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A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Primary Purpose

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HYQVIA
0.25% albumin placebo solution with rHuPH20
IGIV GAMMAGARD LIQUID/KIOVIG
IGIV GAMUNEX®-C
Sponsored by
Baxalta now part of Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammatory Demyelinating Polyradiculoneuropathy focused on measuring Autoimmune Diseases, Polyneuropathies, Nervous System Diseases, Peripheral Nervous System Diseases, Polyradiculoneuropathy, Autoimmune Diseases of the Nervous System, Immunoglobulins, Immune System Diseases, Demyelinating Diseases, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Neuromuscular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males or females of age greater than or equal to (>=)18 years old at the time of screening.
  2. Participant has a documented diagnosis of definite or probable Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) (focal atypical CIDP and pure sensory atypical CIDP will be excluded), as confirmed by a neurologist specializing/experienced in neuromuscular diseases to be consistent with the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2010 criteria (European Federation of Neurological Societies, 2010). Fulfillment of electrodiagnostic criteria must be confirmed by an independent qualified/experienced central reader.
  3. Participant has responded to IgG treatment in the past (partial or complete resolution of neurological symptoms and deficits), and must currently be on stable doses of IGIV treatment within the dose range equivalent to a cumulative monthly dose of 0.4 to 2.4 gram per kilogram (g/kg) BW (inclusive) administered intravenously for at least 12 weeks prior to screening. The dosing interval of IGIV treatment must be between 2 and 6 weeks (inclusive). Variations in the dosing interval of up to ± 7 days or monthly dose amount of up to ± 20% between participant's pre-study Immunoglobulin G (IgG) infusions are within acceptable limits.
  4. INCAT disability score between 0 and 7 (inclusive). Participants with INCAT scores of 0, 1 (whether from upper or lower extremities), or 2 (if at least 1 point is from an upper extremity) at screening and/or baseline will be required to have a history of significant disability as defined by an INCAT disability score of 2 (must be exclusively from the lower extremities) or greater documented in the medical record. Participants will be eligible if one of the below eligibility criteria are met:

    Screening and Baseline INCAT disability score of between 3 and 7 inclusive.

    1. Screening and/or Baseline INCAT disability score of 2 (both points are from lower extremities).
    2. Screening and/or Baseline INCAT disability score of 2 (both points are not from lower extremities) AND has at least a score of 2 or greater documented in the medical record prior to screening. If a score was greater than 2 documented in the medical record prior to screening at least 2 points must be from lower extremities.
    3. Screening and/or Baseline INCAT disability score of 0 or 1 AND has at least a score of 2 or greater (both from lower extremities) documented in the medical record prior to screening, at least 2 points must be from lower extremities.
  5. If female of childbearing potential, the participant must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the study and for at least 30 days after the last administration of investigational product (IP).
  6. Participant is willing and able to sign an Informed Consent Form (ICF).
  7. Participant is willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

  1. Participants with Focal atypical CIDP or pure sensory atypical CIDP.
  2. Any neuropathy of other causes, including:

    1. Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth [CMT] disease), and hereditary sensory and autonomic neuropathies (HSANs).
    2. Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and non-diabetic lumbosacral radiculoplexus neuropathy, lymphoma, and amyloidosis.
    3. Multifocal acquired demyelinating sensory and motor neuropathy (MADSAM).
    4. Multifocal motor neuropathy (MMN).
    5. Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy.
  3. Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titer antibodies to myelin-associated glycoprotein.
  4. Prominent sphincter disturbance.
  5. Central demyelinating disorders (eg, multiple sclerosis).
  6. Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures (eg, arthritis, stroke, Parkinson's disease, and diabetic peripheral neuropathy) (Participants with clinically diagnosed diabetes mellitus who do not have diabetic peripheral neuropathy, who have adequate glycemic control with Hemoglobin A1C; also known as glycosylated or glycated hemoglobin (HbA1C) of less than (<) 7.5% at screening, and who agree to maintain adequate glycemic control during the study are allowed).
  7. Congestive heart failure (New York Heart Association [NYHA] Class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (ie, diastolic blood pressure greater than (>) 100 millimeter of mercury (mmHg) and/or systolic blood pressure >160 mmHg).
  8. History of deep vein thrombosis or thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) in the past 12 months.
  9. Condition(s) which could alter protein catabolism and/or IgG utilization (eg, protein-losing enteropathies, nephrotic syndrome).
  10. Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) estimated based on CKD-EPI equation (Levey et al., 2009) at the time of screening.
  11. Participant with active malignancy requiring chemotherapy and/or radiotherapy, or history of malignancy with less than 2 years of complete remission prior to screening. Exceptions are: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment.
  12. Clinically significant anemia or hemoglobin (Hgb) level of less than (<) 10.0 grams per deciliter (g/dL) at screening.
  13. Hypersensitivity or adverse reactions (AR's) (eg, urticaria, breathing difficulty, severe hypotension, or anaphylaxis) to human blood products such as human IgG, albumin, or other blood components.
  14. Known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin (such as bee or wasp venom).
  15. Known history of or immunoglobulin A (IgA) deficiency (<8 milligram per deciliter [mg/dL]) at screening.
  16. Abnormal laboratory values at screening:

    1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5* upper limit of normal (ULN)
    2. Platelet count <100,000 cells per microliter (cells/mcL).
    3. Absolute neutrophil count (ANC) <1000 cells/mcL.
  17. Ongoing/active infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) Type 1/2 infection.
  18. The participant has received or is currently receiving treatment with immunomodulatory/ immunosuppressive agents within 6 months prior to screening.
  19. Participant has received or is currently receiving treatment with corticosteroids dose within 8 weeks prior to screening, regardless of indication.
  20. Participant has undergone plasma exchange (PE) within 3 months prior to screening.
  21. The participant has any disorder or condition that in the investigator's judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study.
  22. The participant is nursing or intends to begin nursing during the course of the study.
  23. Participant has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment, or is scheduled to participate in another clinical study (with the exception of the HYQVIA/HyQvia extension study in CIDP) involving an IP or investigational device during the course of this study.
  24. The participant is a family member or employee of the investigator.
  25. Participants with acquired or inherited thrombophilic disorders. These will include the specific types of acquired or inherited thrombophilic disorders that could put participants at risk of develop thrombotic events. Examples include:

    a. Hereditary Thrombophilias i. Factor V Leiden mutation. ii. Prothrombin 20210A mutation. iii. Protein C deficiency. iv. Protein S deficiency. v. Antithrombin deficiency. b. Acquired thrombophilias i. Antiphospholipid antibody syndrome. ii. Activated protein C Resistance acquired. iii. Homocystinemia.

Sites / Locations

  • Barrow Neurological Institute
  • Arizona Neuromuscular Research Center
  • HonorHealth Neurology
  • University of California-Irvine
  • Forbes Norris Mda/als Ctr
  • Regents of the University of colorado
  • Immunoe Research Centers
  • University of South Florida
  • University of Kansas Medical Center Research Institute, Inc.
  • William Beaumont Hospital
  • Neurology Center of Las Vegas
  • Rutgers New Jersey Medical School
  • Hospital for Special Surgery
  • Wake Forest University
  • University of Cincinnati
  • Cleveland Clinic
  • Austin Neuromuscular Center
  • The Methodist Hospital Research Institute
  • University Texas Physicians CAR
  • Hospital Italiano
  • Hospital Britanico de Buenos Aires
  • Complejo Medico de la Policia Federal Argentina Churruca Visca
  • Instituto de Investigaciones Neurologicas Raul Carrea, FLENI
  • Instituto de Neurologia de Curitiba - Hospital Ecoville
  • HUAP - UFF - Hospital Universitario Antonio Pedro - Universidade Federal Fluminense
  • Hospital das Clínicas da Faculdade de Medicina da UNICAMP
  • Hospital das Clínicas FMRP-USP
  • Hospital Sao Paulo
  • University of Alberta Hospital
  • LHSC - University Hospital
  • Toronto General Hospital
  • Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"
  • Clinical Hospital Centre Rijeka
  • Clinical Hospital Centar Zagreb
  • University Hospital Centre "Sestre Milosrdnice"
  • Fakultni nemocnice Brno
  • Fakultni nemocnice Ostrava
  • Fakultni nemocnice v Motole
  • Århus Universitetshospital
  • CHU de Nice Hôpital Pasteur 2
  • Hôpital de la Timone
  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
  • Hopital Neurologique Pierre Wertheimer
  • Universitaetsmedizin Goettingen
  • Universitaetsklinikum Essen
  • Universitaetsklinikum Leipzig AoeR
  • University Hospital of Patra
  • Chaim Sheba Medical Center
  • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Istituto Clinico Humanitas
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Azienda Ospedaliero Universitaria San Martino
  • Azienda Ospedaliera Universitaria Policlinico G. Martino
  • Casa di Cura del Policlinico
  • Fondazione Istituto Neurologico Casimiro Mondino
  • Azienda Ospedaliero Universitaria Pisana
  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
  • Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
  • Oslo Universitetssykehus HF, Ullevål
  • COPERNICUS Podmiot Leczniczy Sp. z o. o.,
  • Uniwersyteckie Centrum Kliniczne
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
  • Clinical Center of Serbia
  • Military Medical Academy
  • Clinical Center Nis
  • Univerzitna nemocnica Bratislava Nemocnica ak. L. Derera, II. Neurologicka klinika
  • Fakultna nemocnica Nitra
  • Hospital Universitari de Bellvitge
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario Virgen del Rocio
  • Hallands sjukhus
  • Pamukkale Uni. Med. Fac.
  • Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
  • Dokuz Eylul University Faculty of Medicine
  • Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
  • Celal Bayar University Medical Faculty
  • Southmead Hospital
  • King's College Hospital
  • The Walton Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Epoch 1: HYQVIA/HyQvia

Epoch 1: Placebo with rHuPH20

Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG

Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG

Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C

Arm Description

Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, following by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.

Participants received rHuPH20 80 U/I0 mL placebo solution, followed by SC placebo infusion at matching infusion volume as the participant's pre-randomization monthly equivalent IG dose when administered every 2, 3, or 4 weeks for 31.54 weeks or until relapse.

Participants who were enrolled to receive placebo with rHuPH20 and achieved chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg bi-weekly (BW), followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.

Participants who were enrolled to receive HYQVIA/HyQvia (rHuPH20) and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 28.67 weeks or until relapse.

Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.

Outcomes

Primary Outcome Measures

Epoch 1: Relapse Rate
Relapse rate is defined as the percentage of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
Epoch 2: Responder Rate
Responder rate is defined as clinically meaningful improvement in functional ability defined as a decrease of >=1 point in the adjusted INCAT disability score at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.

Secondary Outcome Measures

Epoch 1: Percentage of Participants Who Experience a Worsening of Functional Disability
Defined as one or more of the following: an increase of >=1 point relative to the pre-subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) scores; who experience CIDP worsening (defined as a >=8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand); >=4 points decrease in raw Rasch-built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score (at the time of withdrawal from the SC treatment period). Participants are rounded off to nearest single decimal point.
Time to Relapse
Time to relapse is defined as time from the date of the first SC administration of HYQVIA/HyQvia or placebo with rHuPH20 to the date of relapse. Participants who did not relapse were censored at their end of study.
Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS)
The Rasch-Built Overall Disability Scale (R-ODS) is a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participant with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (i.e, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion. The centile metric R-ODS score range is 0 to 100. Higher scores indicate better condition. The centile metric R-ODS score was used in the ANCOVA analysis. ANCOVA was used for the analysis.
Epoch 1: Number of Participants Experiencing Any Treatment-Emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality
An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
Epoch 1: Number of Participants Experiencing Causally Related Serious and/or Non-Serious Adverse Events (SAEs and/or AEs)
AE=any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g.,abnormal laboratory finding), symptom (e.g.,rash, pain, discomfort, fever, dizziness, etc.), disease (e.g.,peritonitis,bacteremia,etc.), outcome of death temporally associated with use of IP,considered causally related to the IP. SAE=untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, thromboembolic events, hemolytic anemia. Non-SAE=AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Epoch 1: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
Epoch 1: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality
AE: any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. SAE: an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. Participants can have more than one adverse event.
Epoch 1: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Epoch 1: Number of Adverse Events (AEs) Temporally Associated With Infusions
AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Participants can have more than one temporally associated with infusion adverse event.
Epoch 1: Number of Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Associated With Infusions
AR plus suspected AR: any AE that meets any of the criteria: AE considered by either investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following end of IP infusion, or AE for which causality assessment is missing or indeterminate. SAE: untoward medical occurrence that at any dose meets one or more of following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. Nonserious AE is AE that does not meet the criteria. Infusion per event = number of events / total number of infusions administered (started) to participants in analysis set. Participants can have more than one AR/suspected AR associated with infusion.
Epoch 1: Number of Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. Participants can have more than one TEAE associated with infusion.
Epoch 1: Number of Treatment-emergent Local Infusion Site Reactions Associated With Infusions
AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. Treatment-emergent adverse events (TEAEs) are defined as adverse events that occurred during or after administration of the first dose of IP. Infusion site adverse events and injection site adverse events refer to the same type of adverse events.
Epoch 1: Number of Infusions in Participants for Which the Infusion Rate Was Reduced And/Or the Infusion Was Interrupted or Stopped Due to Intolerability And/Or Adverse Events (AEs)
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Participant
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-year
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE.
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Infusion
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Participant
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per 1000 Participant-Year
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
Epoch 1: Number of Participants Who Develop Binding and/or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)
Number of participants who developed binding and/or neutralizing antibodies to rHuPH20 in Epoch 1 were reported. High-binding antibodies is defined as number of participants who had at least one anti-rHuPH20 antibody titer ≥1:160 during treatment.
Epoch 2: Number of Participants Experiencing Any Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality
Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events regardless of causality in Epoch 2 was reported.
Epoch 2: Number of Participants Experiencing Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs)
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Epoch 2: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs
An adverse reaction/suspected adverse reaction is defined as an Adverse Event that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion.
Epoch 2: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality
A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Participants can have more than one adverse event.
Epoch 2: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Epoch 2: Number of Adverse Events (AEs) Temporally Associated With Infusions
AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Participants can have more than one adverse event.
Epoch 2: Number of Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Associated With Infusions
A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Participants can have more than one AR/SAR.
Epoch 2: Number of Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. Participants can have more than one treatment-emergent systemic AEs.
Epoch 2: Number of Treatment-emergent Local Infusion Site Reactions Associated With Infusions
AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. TEAEs are defined as adverse events that occurred during or after administration of the first dose of IP. Infusion site adverse events and injection site adverse events refer to the same type of adverse events.
Epoch 2: Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-Year
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE.
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected Ars, Expressed as Number of Events Per Infusion
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Participant
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per 1000 Participant-Year
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
Epoch 2: Percentage of Participants With Clinically Meaningful Improvement in Functional Ability
Defined as one or more of the following: a decrease of >=1 point in the adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) score at 2 consecutive time points; who experience CIDP improvement (defined as ≥8 kilo Pascal (kPa) increase in hand grip strength in the more affected hand; >=4 points increase in Rasch-built Overall Disability Scale (R-ODS)) at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.

Full Information

First Posted
September 11, 2015
Last Updated
May 23, 2023
Sponsor
Baxalta now part of Shire
Collaborators
Takeda Development Center Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02549170
Brief Title
A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Official Title
A Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) and Immune Globulin Infusion (Human), 10% (GAMMAGARD LIQUID/KIOVIG) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2015 (Actual)
Primary Completion Date
February 23, 2022 (Actual)
Study Completion Date
February 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxalta now part of Shire
Collaborators
Takeda Development Center Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to learn more about the following treatment options in adults with CIDP: Subcutaneous self-infusion with HyQvia. Intravenous infusion with Gammagard/Kiovig. Gammagard and Kiovig are the brand names for the same immunoglobulin compound. The study is in two parts. In Part 1, participants receive either HyQvia or a placebo subcutaneously. In Part 2 (only for participants who have a CIPD relapse during Part 1), participants will receive Gammagard Liquid/Kiovig intravenously. US participants will receive Gamunex-C. The first SC infusion will be given in the study clinic. The remaining SC infusions may be given in the study clinic or the participant's home. This will be decided by the study doctor and whether the participant or their caregiver can do the self-infusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Keywords
Autoimmune Diseases, Polyneuropathies, Nervous System Diseases, Peripheral Nervous System Diseases, Polyradiculoneuropathy, Autoimmune Diseases of the Nervous System, Immunoglobulins, Immune System Diseases, Demyelinating Diseases, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Neuromuscular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epoch 1: HYQVIA/HyQvia
Arm Type
Experimental
Arm Description
Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, following by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.
Arm Title
Epoch 1: Placebo with rHuPH20
Arm Type
Placebo Comparator
Arm Description
Participants received rHuPH20 80 U/I0 mL placebo solution, followed by SC placebo infusion at matching infusion volume as the participant's pre-randomization monthly equivalent IG dose when administered every 2, 3, or 4 weeks for 31.54 weeks or until relapse.
Arm Title
Epoch 2: E1: Placebo Relapse - E2: GGL/KIOVIG
Arm Type
Experimental
Arm Description
Participants who were enrolled to receive placebo with rHuPH20 and achieved chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg bi-weekly (BW), followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 25.63 weeks or until relapse.
Arm Title
Epoch 2: E1: HYQVIA Relapse - E2: GGL/KIOVIG
Arm Type
Experimental
Arm Description
Participants who were enrolled to receive HYQVIA/HyQvia (rHuPH20) and achieved CIDP relapse during Epoch 1 received the induction dose of GGL/KIOVIG 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 28.67 weeks or until relapse.
Arm Title
Epoch 2: E1: Placebo Relapse - E2: GAMMUNEX-C
Arm Type
Experimental
Arm Description
Participants who were enrolled to receive placebo with rHuPH20 and achieved CIDP relapse during Epoch 1 received the induction dose of GAMMUNEX-C 2 g/kg BW, followed by IV infusion at the same monthly equivalent dose as the participant's pre-randomization IGIV dosing regimen when administered every 3 weeks for 24.33 weeks or until relapse.
Intervention Type
Biological
Intervention Name(s)
HYQVIA
Other Intervention Name(s)
10%) with recombinant human hyaluronidase (rHuPH20), Immune Globulin Infusion 10% (Human) (IGI, IGI, 10% with rHuPH20
Intervention Description
Participants will receive HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
Intervention Type
Biological
Intervention Name(s)
0.25% albumin placebo solution with rHuPH20
Intervention Description
Participants will receive placebo solution (0.25% human albumin in Lactated Ringer's solution) and rHuPH20.
Intervention Type
Biological
Intervention Name(s)
IGIV GAMMAGARD LIQUID/KIOVIG
Other Intervention Name(s)
Immune Globulin Infusion (Human), Intravenous immunoglobulin G, 10% (GAMMAGARD LIQUID/KIOVIG), GAMMAGARD LIQUID
Intervention Description
Participants will receive GAMMAGARD LIQUID/KIOVIG
Intervention Type
Biological
Intervention Name(s)
IGIV GAMUNEX®-C
Other Intervention Name(s)
Immune Globulin Infusion (Human), Intravenous immunoglobulin G, Approved IGIV product for US sites
Intervention Description
Participants will receive GAMUNEX®-C
Primary Outcome Measure Information:
Title
Epoch 1: Relapse Rate
Description
Relapse rate is defined as the percentage of participants who experience a worsening of functional disability. Worsening of functional disability defined as an increase of >=1 point relative to the pre- subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. The INCAT disability score is an effective and responsive tool to assess clinical response to treatment in CIDP. The disability score ranges from 0 to 10 points, where 0 is normal (eg, no upper limb problems and walking not affected) and 10 is severely incapacitated (eg, inability to move either arm for any purposeful movement and restricted to wheelchair, unable to stand and walk a few steps with help).
Time Frame
Week 32 End of Epoch 1 Treatment (EOET1)/Unscheduled relapse visit assessment (UV)/Early Termination (ET)
Title
Epoch 2: Responder Rate
Description
Responder rate is defined as clinically meaningful improvement in functional ability defined as a decrease of >=1 point in the adjusted INCAT disability score at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.
Time Frame
Up to 6 Months post-Epoch 1 (End of Epoch 2 Treatment [EOE2T])/Unscheduled visit assessment (UV)/Early Termination
Secondary Outcome Measure Information:
Title
Epoch 1: Percentage of Participants Who Experience a Worsening of Functional Disability
Description
Defined as one or more of the following: an increase of >=1 point relative to the pre-subcutaneous (SC) treatment baseline score in 2 consecutive adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) scores; who experience CIDP worsening (defined as a >=8 kilo Pascal (kPa) decrease in the hand grip strength in the more affected hand); >=4 points decrease in raw Rasch-built Overall Disability Scale (R-ODS) relative to the pre-SC treatment baseline score (at the time of withdrawal from the SC treatment period). Participants are rounded off to nearest single decimal point.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Time to Relapse
Description
Time to relapse is defined as time from the date of the first SC administration of HYQVIA/HyQvia or placebo with rHuPH20 to the date of relapse. Participants who did not relapse were censored at their end of study.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Change From Pre-Subcutaneous (SC) Treatment Baseline in Rasch-built Overall Disability Scale (R-ODS)
Description
The Rasch-Built Overall Disability Scale (R-ODS) is a participant self-reported, linearly-weighted overall disability scale that was specifically designed to capture activity and social participation limitations in participant with immune-mediated peripheral neuropathies including CIDP. The R-ODS is comprised of 24 items for which participants are asked to rate their functioning (i.e, no difficulty, some difficulty, or could not do) related to a variety of everyday tasks at the moment of completion. The centile metric R-ODS score range is 0 to 100. Higher scores indicate better condition. The centile metric R-ODS score was used in the ANCOVA analysis. ANCOVA was used for the analysis.
Time Frame
Pre-subcutaneous (SC) treatment baseline, end of Epoch 1 treatment (approximately 7.3 months)
Title
Epoch 1: Number of Participants Experiencing Any Treatment-Emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality
Description
An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Number of Participants Experiencing Causally Related Serious and/or Non-Serious Adverse Events (SAEs and/or AEs)
Description
AE=any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g.,abnormal laboratory finding), symptom (e.g.,rash, pain, discomfort, fever, dizziness, etc.), disease (e.g.,peritonitis,bacteremia,etc.), outcome of death temporally associated with use of IP,considered causally related to the IP. SAE=untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, thromboembolic events, hemolytic anemia. Non-SAE=AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs
Description
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality
Description
AE: any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. SAE: an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. Participants can have more than one adverse event.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions
Description
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Number of Adverse Events (AEs) Temporally Associated With Infusions
Description
AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an Investigational Product (IP) that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Participants can have more than one temporally associated with infusion adverse event.
Time Frame
During an infusion or within 72 hours after completion of an infusion (up to Week 32)
Title
Epoch 1: Number of Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Associated With Infusions
Description
AR plus suspected AR: any AE that meets any of the criteria: AE considered by either investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following end of IP infusion, or AE for which causality assessment is missing or indeterminate. SAE: untoward medical occurrence that at any dose meets one or more of following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. Nonserious AE is AE that does not meet the criteria. Infusion per event = number of events / total number of infusions administered (started) to participants in analysis set. Participants can have more than one AR/suspected AR associated with infusion.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Number of Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions
Description
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. Participants can have more than one TEAE associated with infusion.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Number of Treatment-emergent Local Infusion Site Reactions Associated With Infusions
Description
AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. Treatment-emergent adverse events (TEAEs) are defined as adverse events that occurred during or after administration of the first dose of IP. Infusion site adverse events and injection site adverse events refer to the same type of adverse events.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Number of Infusions in Participants for Which the Infusion Rate Was Reduced And/Or the Infusion Was Interrupted or Stopped Due to Intolerability And/Or Adverse Events (AEs)
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Participant
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-year
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Infusion
Description
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Participant
Description
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per 1000 Participant-Year
Description
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 1: Number of Participants Who Develop Binding and/or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)
Description
Number of participants who developed binding and/or neutralizing antibodies to rHuPH20 in Epoch 1 were reported. High-binding antibodies is defined as number of participants who had at least one anti-rHuPH20 antibody titer ≥1:160 during treatment.
Time Frame
Week 32 (EOET1)/UV/ET
Title
Epoch 2: Number of Participants Experiencing Any Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs), Regardless of Causality
Description
Number of participants experiencing any treatment-emergent serious and/or non-serious adverse events regardless of causality in Epoch 2 was reported.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Number of Participants Experiencing Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs)
Description
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Number of Participants With Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs
Description
An adverse reaction/suspected adverse reaction is defined as an Adverse Event that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Number of Treatment-emergent Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions Regardless of Causality
Description
A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Participants can have more than one adverse event.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Number of Causally Related Serious and/or Non-serious Adverse Events (SAEs and/or AEs) Associated With Infusions
Description
AE: any untoward medical occurrence in participant administered IP. AE can therefore be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), outcome of death temporally associated with use of IP, whether or not considered causally related to the IP. SAE: untoward medical occurrence that at any dose meets following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization/results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect, is medically important event, (e.g., thromboembolic events, hemolytic anemia). Non-SAE:AE not meeting this criteria. AE recorded by investigator as possibly/probably related to IP is considered related AE, any AE recorded as unlikely/not related is considered unrelated AE.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Number of Adverse Events (AEs) Temporally Associated With Infusions
Description
AEs occurring during an infusion or within 72 hours after completion of an infusion. An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Participants can have more than one adverse event.
Time Frame
During an infusion or within 72 hours after completion of an infusion (up to Week 32)
Title
Epoch 2: Number of Serious and/or Non-serious Adverse Reactions (ARs) Plus Suspected ARs Associated With Infusions
Description
A SAE is defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome is fatal/results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event, thromboembolic events, hemolytic anemia. A nonserious AE is an AE that does not meet the criteria. An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Participants can have more than one AR/SAR.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Number of Treatment-emergent Systemic Adverse Events (AEs) Associated With Infusions
Description
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. Participants can have more than one treatment-emergent systemic AEs.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Number of Treatment-emergent Local Infusion Site Reactions Associated With Infusions
Description
AE=any untoward medical occurrence in participant administered an IP that does not have causal relationship with treatment. AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Adverse reaction/suspected adverse reaction=AE that is considered by the investigator to be possibly or probably related to IP administration, or for which the causality is indeterminate or missing, or that begins during infusion of IP or within 72 hours following the end of IP infusion. TEAEs are defined as adverse events that occurred during or after administration of the first dose of IP. Infusion site adverse events and injection site adverse events refer to the same type of adverse events.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Intolerability and/or Adverse Events (AEs)
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Infusion
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per Participant
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Rates of Systemic and Local Adverse Events (AEs), Regardless of Causality, Expressed as Number of Events Per 1000 Participant-year
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed As Number of Events Per Infusion
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Rates of Causally Related Systemic and Local Adverse Events (AEs), Expressed as Number of Events Per Participant-Year
Description
An AE is defined as any untoward medical occurrence in participant administered an IP that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an IP, whether or not considered causally related to the IP. An AE that is recorded by the investigator as possibly related or probably related to IP was considered a related AE, and any AE recorded as unlikely related or not related was considered unrelated AE.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected Ars, Expressed as Number of Events Per Infusion
Description
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per infusion is assessed at the group level as follows: Per infusion = number of events / total number of infusions administered (started) to participants in the analysis set.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per Participant
Description
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data is reported for number of events per participant which is assessed at the group level as follows: AE per participant = number of AEs/ total number of participants in the safety analysis set.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Rates of Systemic and Local Adverse Reactions (ARs) Plus Suspected ARs, Expressed as Number of Events Per 1000 Participant-Year
Description
An AR plus suspected AR is any AE that meets any of the following criteria: an AE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or that begins during infusion of IP or within 72 h following the end of IP infusion, or AE for which causality assessment is missing or indeterminate. Data for number of events per 1000 participant-years is assessed as follows: Per 1000 participant-years = 1000 x (number of events / total number of days of exposure, i.e., the sum of duration of treatment for all participants in the safety analysis set, divided by 365.25)
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1
Title
Epoch 2: Percentage of Participants With Clinically Meaningful Improvement in Functional Ability
Description
Defined as one or more of the following: a decrease of >=1 point in the adjusted Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) score at 2 consecutive time points; who experience CIDP improvement (defined as ≥8 kilo Pascal (kPa) increase in hand grip strength in the more affected hand; >=4 points increase in Rasch-built Overall Disability Scale (R-ODS)) at the completion of the intravenous (IV) treatment period [6 months] or at the last study visit of the IV treatment period, relative to the pre-IV treatment baseline score.
Time Frame
Throughout Epoch 2, up to 6 months post-Epoch 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females of age greater than or equal to (>=)18 years old at the time of screening. Participant has a documented diagnosis of definite or probable Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) (focal atypical CIDP and pure sensory atypical CIDP will be excluded), as confirmed by a neurologist specializing/experienced in neuromuscular diseases to be consistent with the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2010 criteria (European Federation of Neurological Societies, 2010). Fulfillment of electrodiagnostic criteria must be confirmed by an independent qualified/experienced central reader. Participant has responded to IgG treatment in the past (partial or complete resolution of neurological symptoms and deficits), and must currently be on stable doses of IGIV treatment within the dose range equivalent to a cumulative monthly dose of 0.4 to 2.4 gram per kilogram (g/kg) BW (inclusive) administered intravenously for at least 12 weeks prior to screening. The dosing interval of IGIV treatment must be between 2 and 6 weeks (inclusive). Variations in the dosing interval of up to ± 7 days or monthly dose amount of up to ± 20% between participant's pre-study Immunoglobulin G (IgG) infusions are within acceptable limits. INCAT disability score between 0 and 7 (inclusive). Participants with INCAT scores of 0, 1 (whether from upper or lower extremities), or 2 (if at least 1 point is from an upper extremity) at screening and/or baseline will be required to have a history of significant disability as defined by an INCAT disability score of 2 (must be exclusively from the lower extremities) or greater documented in the medical record. Participants will be eligible if one of the below eligibility criteria are met: Screening and Baseline INCAT disability score of between 3 and 7 inclusive. Screening and/or Baseline INCAT disability score of 2 (both points are from lower extremities). Screening and/or Baseline INCAT disability score of 2 (both points are not from lower extremities) AND has at least a score of 2 or greater documented in the medical record prior to screening. If a score was greater than 2 documented in the medical record prior to screening at least 2 points must be from lower extremities. Screening and/or Baseline INCAT disability score of 0 or 1 AND has at least a score of 2 or greater (both from lower extremities) documented in the medical record prior to screening, at least 2 points must be from lower extremities. If female of childbearing potential, the participant must have a negative pregnancy test at screening and agree to employ a highly effective contraceptive measure throughout the course of the study and for at least 30 days after the last administration of investigational product (IP). Participant is willing and able to sign an Informed Consent Form (ICF). Participant is willing and able to comply with the requirements of the protocol. Exclusion Criteria: Participants with Focal atypical CIDP or pure sensory atypical CIDP. Any neuropathy of other causes, including: Hereditary demyelinating neuropathies, such as hereditary sensory and motor neuropathy (HSMN) (Charcot-Marie-Tooth [CMT] disease), and hereditary sensory and autonomic neuropathies (HSANs). Neuropathies secondary to infections, disorders, or systemic diseases such as Borrelia burgdorferi infection (Lyme disease), diphtheria, systemic lupus erythematosus, POEMS (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes) syndrome, osteosclerotic myeloma, diabetic and non-diabetic lumbosacral radiculoplexus neuropathy, lymphoma, and amyloidosis. Multifocal acquired demyelinating sensory and motor neuropathy (MADSAM). Multifocal motor neuropathy (MMN). Drug-, biologic-, chemotherapy-, or toxin-induced peripheral neuropathy. Immunoglobulin M (IgM) paraproteinemia, including IgM monoclonal gammopathy with high titer antibodies to myelin-associated glycoprotein. Prominent sphincter disturbance. Central demyelinating disorders (eg, multiple sclerosis). Any chronic or debilitating disease, or central nervous disorder that causes neurological symptoms or may interfere with assessment of CIDP or outcome measures (eg, arthritis, stroke, Parkinson's disease, and diabetic peripheral neuropathy) (Participants with clinically diagnosed diabetes mellitus who do not have diabetic peripheral neuropathy, who have adequate glycemic control with Hemoglobin A1C; also known as glycosylated or glycated hemoglobin (HbA1C) of less than (<) 7.5% at screening, and who agree to maintain adequate glycemic control during the study are allowed). Congestive heart failure (New York Heart Association [NYHA] Class III/IV), unstable angina, unstable cardiac arrhythmias, or uncontrolled hypertension (ie, diastolic blood pressure greater than (>) 100 millimeter of mercury (mmHg) and/or systolic blood pressure >160 mmHg). History of deep vein thrombosis or thromboembolic events (eg, cerebrovascular accident, pulmonary embolism) in the past 12 months. Condition(s) which could alter protein catabolism and/or IgG utilization (eg, protein-losing enteropathies, nephrotic syndrome). Known history of chronic kidney disease, or glomerular filtration rate (GFR) of <60 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) estimated based on CKD-EPI equation (Levey et al., 2009) at the time of screening. Participant with active malignancy requiring chemotherapy and/or radiotherapy, or history of malignancy with less than 2 years of complete remission prior to screening. Exceptions are: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment. Clinically significant anemia or hemoglobin (Hgb) level of less than (<) 10.0 grams per deciliter (g/dL) at screening. Hypersensitivity or adverse reactions (AR's) (eg, urticaria, breathing difficulty, severe hypotension, or anaphylaxis) to human blood products such as human IgG, albumin, or other blood components. Known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or animal origin (such as bee or wasp venom). Known history of or immunoglobulin A (IgA) deficiency (<8 milligram per deciliter [mg/dL]) at screening. Abnormal laboratory values at screening: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5* upper limit of normal (ULN) Platelet count <100,000 cells per microliter (cells/mcL). Absolute neutrophil count (ANC) <1000 cells/mcL. Ongoing/active infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) Type 1/2 infection. The participant has received or is currently receiving treatment with immunomodulatory/ immunosuppressive agents within 6 months prior to screening. Participant has received or is currently receiving treatment with corticosteroids dose within 8 weeks prior to screening, regardless of indication. Participant has undergone plasma exchange (PE) within 3 months prior to screening. The participant has any disorder or condition that in the investigator's judgment may impede the participant's participation in the study, pose increased risk to the participant, or confound the results of the study. The participant is nursing or intends to begin nursing during the course of the study. Participant has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment, or is scheduled to participate in another clinical study (with the exception of the HYQVIA/HyQvia extension study in CIDP) involving an IP or investigational device during the course of this study. The participant is a family member or employee of the investigator. Participants with acquired or inherited thrombophilic disorders. These will include the specific types of acquired or inherited thrombophilic disorders that could put participants at risk of develop thrombotic events. Examples include: a. Hereditary Thrombophilias i. Factor V Leiden mutation. ii. Prothrombin 20210A mutation. iii. Protein C deficiency. iv. Protein S deficiency. v. Antithrombin deficiency. b. Acquired thrombophilias i. Antiphospholipid antibody syndrome. ii. Activated protein C Resistance acquired. iii. Homocystinemia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Shire
Official's Role
Study Director
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Arizona Neuromuscular Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
HonorHealth Neurology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
University of California-Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Forbes Norris Mda/als Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Regents of the University of colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Immunoe Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Kansas Medical Center Research Institute, Inc.
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073-6769
Country
United States
Facility Name
Neurology Center of Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0525
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Austin Neuromuscular Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Texas Physicians CAR
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hospital Italiano
City
Ciudad Autonoma Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Complejo Medico de la Policia Federal Argentina Churruca Visca
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
1416
Country
Argentina
Facility Name
Instituto de Investigaciones Neurologicas Raul Carrea, FLENI
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1428AQK
Country
Argentina
Facility Name
Instituto de Neurologia de Curitiba - Hospital Ecoville
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
81210-310
Country
Brazil
Facility Name
HUAP - UFF - Hospital Universitario Antonio Pedro - Universidade Federal Fluminense
City
Niterói
State/Province
Rio Do Janeiro
ZIP/Postal Code
24033-900
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da UNICAMP
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13083-887
Country
Brazil
Facility Name
Hospital das Clínicas FMRP-USP
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Hospital Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04039-032
Country
Brazil
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
LHSC - University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"
City
Medellin
ZIP/Postal Code
00000
Country
Colombia
Facility Name
Clinical Hospital Centre Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Clinical Hospital Centar Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Centre "Sestre Milosrdnice"
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Århus Universitetshospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
CHU de Nice Hôpital Pasteur 2
City
Nice Cedex 1
State/Province
Alpes Maritimes
ZIP/Postal Code
06001
Country
France
Facility Name
Hôpital de la Timone
City
Marseille cedex 5
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13385
Country
France
Facility Name
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
City
Bordeaux Cedex
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Neurologique Pierre Wertheimer
City
Bron cedex
State/Province
Rhone
ZIP/Postal Code
69677
Country
France
Facility Name
Universitaetsmedizin Goettingen
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
State/Province
Nordrhein Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitaetsklinikum Leipzig AoeR
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
University Hospital of Patra
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico G. Martino
City
Messina
ZIP/Postal Code
98122
Country
Italy
Facility Name
Casa di Cura del Policlinico
City
Milano
ZIP/Postal Code
20144
Country
Italy
Facility Name
Fondazione Istituto Neurologico Casimiro Mondino
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Oslo Universitetssykehus HF, Ullevål
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
COPERNICUS Podmiot Leczniczy Sp. z o. o.,
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
City
Łódź
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Univerzitna nemocnica Bratislava Nemocnica ak. L. Derera, II. Neurologicka klinika
City
Bratislava
ZIP/Postal Code
83101
Country
Slovakia
Facility Name
Fakultna nemocnica Nitra
City
Nitra
ZIP/Postal Code
95001
Country
Slovakia
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hallands sjukhus
City
Halmstad
ZIP/Postal Code
302 33
Country
Sweden
Facility Name
Pamukkale Uni. Med. Fac.
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Dokuz Eylul University Faculty of Medicine
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
City
Konya
ZIP/Postal Code
42075
Country
Turkey
Facility Name
Celal Bayar University Medical Faculty
City
Manisa
ZIP/Postal Code
45040
Country
Turkey
Facility Name
Southmead Hospital
City
Bristol
State/Province
Avon
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
King's College Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Walton Centre
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L9 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f6b5fc54db2bf003ab45bd5
Description
To obtain more information on the study, click here/on this link

Learn more about this trial

A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

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