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Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP

Primary Purpose

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HYQVIA
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

Eligibility Criteria

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

Inclusion Criteria:

  1. Has completed Epoch 1 of Study 161403 without CIDP worsening.
  2. If female of childbearing potential, the participant must have a negative pregnancy test at baseline and agree to employ adequate birth control measures (eg, birth control pills/patches, intrauterine device, or diaphragm or condom [for male partner] with spermicidal jelly or foam) throughout the course of the study.

Exclusion Criteria:

  1. Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this Extension Study.
  2. New medical condition that developed during participation in study 161403 that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of investigational medicinal product (IMP) and/or conduct of the study.
  3. Participant is scheduled to participate in another non-Baxalta clinical study involving an IP or investigational device during the course of this study.
  4. The participant is nursing or intends to begin nursing during the course of the study
  5. Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study (with the exception of study 161403) involving an IP or investigational device during the course of this study.
  6. The participant is a family member or employee of the investigator.

Sites / Locations

  • Arizona Neuromuscular Research Center
  • Hosp.Britanico de Buenos Aires
  • Instituto de Neurologia de Curitiba - Hospital Ecoville
  • University of Alberta Hospital
  • LHSC - University Hospital
  • Toronto General Hospital, University Health Network
  • Institucion Prestadora de Servicios de Salud de la Universidad de Antioquia "IPS UNIVERSITARIA"
  • Fakultni nemocnice Ostrava
  • Fakultni nemocnice v Motole
  • Århus Universitetshospital
  • CHU de Nice
  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
  • Hopital Neurologique Pierre Wertheimer
  • Universitaetsklinikum Leipzig AoeR
  • University Hospital of Patra
  • Azienda Ospedaliero Universitaria San Martino
  • Azienda Ospedaliera Universitaria Policlinico G. Martino
  • Fondazione Istituto Neurologico Casimiro Mondino
  • Azienda Ospedaliero Universitaria Pisana
  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
  • Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
  • 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
  • Fakultna nemocnica Nitra
  • Hospital Universitari Vall d'Hebron
  • Pamukkale Uni. Med. Fac.
  • Dokuz Eylul University Faculty of Medicine
  • Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi
  • Celal Bayar University Medical Faculty
  • King's College Hospital
  • The Walton Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HYQVIA

Arm Description

Subjects will continue to receive HYQVIA/HyQvia infusions every 2, or 3, or 4 weeks (±3 days) following the same dose and dosing regimen of the Phase 3 pivotal study (Study 161403).

Outcomes

Primary Outcome Measures

Number of Participants Experiencing any Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs), Regardless of Causality
Number of participants experiencing any treatment-emergent SAEs and/or AEs, regardless of causality will be assessed. An AE is defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. A serious adverse event (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.
Number of Participants Experiencing Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs)
Number of participants experiencing causally related SAEs and/or AEs will be assessed.
Number of Participants with Serious and/or Non-Serious Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs)
Number of participants with serious and/or non-serious ARs plus suspected ARs will be assessed. 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 an AE that begins during infusion of IP or within 72 hours following the end of IP infusion, or an AE for which causality assessment is missing or indeterminate.
Rate of Adverse Events (AEs) that may be a Result of Immune-Mediated Responses
Rate of AEs that may be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other factors such as allergic reactions, immune complex mediated reactions -local, Immune complex mediated reactions-systemic which will be expressed as the number of events per infusion and per participant-year will be assessed.
Number of Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions, Regardless of Causality
Causality is a determination of whether there is a reasonable possibility that the IP is etiologically related to/associated with the AE. Number of treatment-emergent serious adverse events (SAEs) and/or adverse events (AEs) associated with infusions, regardless of causality will be assessed.
Number of Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions
Number of causally related serious adverse events (SAEs) and/or adverse events (AEs) associated with infusions will be assessed.
Number of Adverse Events (AEs) Temporally Associated with Infusions
Number of AEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion will be assessed.
Number of Serious and/or Non-Serious Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Associated with Infusions
Number of serious and/or non-serious ARs plus suspected ARs associated with infusions will be assessed.
Number of Infusions Associated with One or More Systemic Adverse Events (AEs)
Number of infusions associated with 1 or more systemic AEs will be assessed.
Number of Infusions Associated with One or More Local Infusion Site Reactions
Number of infusions associated with 1 or more local infusion site reactions will be assessed.
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)
Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs will be assessed.
Rates of Systemic and local Adverse Events (AEs), Regardless of Causality
Rates of systemic and local AEs, regardless of causality will be expressed as number of events per infusion, per participant, and per participant-year.
Rates of Causally Related Systemic and Local Adverse Events (AEs)
Rates of causally related systemic and local AEs, will be expressed as number of events per infusion, per participant, and per participant-year.
Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs)
Rates of systemic and local adverse reactions (ARs) plus suspected ARs, will be expressed as number of events per infusion, per participant, and per participant-year.
Number of Participants with an Adverse Event (AE) that led to Discontinuation from Study
Number of participants with an adverse event (AE) that led to discontinuation from study will be assessed.
Number of Moderate or Severe Adverse Events (AEs) that may be a Result of Immune-Mediated Responses
Number of moderate or severe adverse events (AEs) that may be a result of immune-mediated responses will be assessed.
Rate per Infusion of Moderate or Severe Adverse Events (AEs) that may be a Result of Immune-Mediated Responses
Rate per infusion of moderate or severe adverse events (AEs) that may be a result of immune-mediated responses will be assessed.
Number of Participants Experiencing Treatment-Emergent Local Infusion Site Reactions
Number of participants experiencing treatment-emergent local infusion site reactions will be assessed. All local infusion site treatment-emergent AEs will be reported as adverse reactions.
Number of Participants with Treatment-Emergent with Local Tolerability Events
Number of participants with treatment-emergent with local tolerability events during the first 8 weeks of open-label extension study 161505 among participants originally randomized to placebo (no ramp up), versus during the 8 week-ramp-up period for participants originally randomized to HYQVIA in double-blind Study 161403 will be assessed.
Number of Participants in whom Infusion Rate was Reduced and/or the Infusion was Interrupted or Stopped due to Intolerability and/or Adverse Events (AEs)
Number of participants in whom infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs will be assessed.
Number of Participants with Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate per Site, and Infusion Volume per Site
Number of participants experiencing local infusion reactions, as a function of dosing interval, infusion rate per site, and infusion volume per site will be assessed.
Number of Participants whose Anti-Hyaluronidase Antibody Titers Rise by Greater Than or Equal (> or =) ( 4 Fold from the Original Baseline Value from Study 161403 Using Combined Data from Both Studies (161403 and 161505)
Number of participants whose anti-hyaluronidase antibody titers rise by > or = 4 fold from the original baseline value from study 161403 using combined data from both studies (161403 and 161505) will be assessed.
Incidence of Binding Antibodies to rHuPH20
Incidence of binding antibodies to rHuPH20 will be assessed.
Incidence of Neutralizing Antibodies to rHuPH20
Incidence of neutralizing antibodies to rHuPH20 will be assessed.
Number of Participants with a Decline of Anti-rHuPH20 Antibody Titers to the Antibody Titer Level at Baseline in Study 161403 or Study 161601 and/or to Less than (<)160 at the Study Completion or Early Discontinuation
Number of participants with a decline of anti-rHuPH20 antibody titers to the antibody titer level at baseline in Study 161403 or Study 161601 and/or to <160 at the study completion or early discontinuation will be assessed.
Number of Participants who have Greater than (>) 10,000 Titer of Binding Antibodies to rHuPH20: Neutralizing Antibodies and Cross Reactivity with Hyal-1,2 and 4
Number of participants who have >10,000 titer of binding antibodies to rHuPH20: neutralizing antibodies and cross reactivity with Hyal-1,2 and 4 will be assessed.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2016
Last Updated
July 21, 2023
Sponsor
Baxalta now part of Shire
Collaborators
Takeda Development Center Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02955355
Brief Title
Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
Official Title
Long-Term Tolerability and Safety of Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) for the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
July 4, 2023 (Actual)
Study Completion Date
July 4, 2023 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have completed study 161403 will be able to take part in this study. The main aim of the study is to evaluate side effects in the long-term treatment with HYQVIA/HyQvia. All participants will receive HYQVIA/HyQvia in the same way as they were receiving in study 161403. The dosing interval of HYQVIA/HyQvia can be adjusted after 12 weeks of treatment in study 161505 if the study doctor determines that it is safe to do so. Participants will visit the clinic within 1 week after the first and second dose of HYQVIA/HyQvia and then every 12 weeks for the duration of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyradiculoneuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HYQVIA
Arm Type
Experimental
Arm Description
Subjects will continue to receive HYQVIA/HyQvia infusions every 2, or 3, or 4 weeks (±3 days) following the same dose and dosing regimen of the Phase 3 pivotal study (Study 161403).
Intervention Type
Biological
Intervention Name(s)
HYQVIA
Other Intervention Name(s)
IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) (IGI 10%) with recombinant human hyaluronidase (rHuPH20)
Intervention Description
Participants will receive subcutaneous (SC) HYQVIA/HyQvia which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
Primary Outcome Measure Information:
Title
Number of Participants Experiencing any Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs), Regardless of Causality
Description
Number of participants experiencing any treatment-emergent SAEs and/or AEs, regardless of causality will be assessed. An AE is defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. A serious adverse event (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.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Participants Experiencing Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs)
Description
Number of participants experiencing causally related SAEs and/or AEs will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Participants with Serious and/or Non-Serious Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs)
Description
Number of participants with serious and/or non-serious ARs plus suspected ARs will be assessed. 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 an AE that begins during infusion of IP or within 72 hours following the end of IP infusion, or an AE for which causality assessment is missing or indeterminate.
Time Frame
Throughout the study period of approximately 7 years
Title
Rate of Adverse Events (AEs) that may be a Result of Immune-Mediated Responses
Description
Rate of AEs that may be a result of immune-mediated response to either immunoglobulin, rHuPH20, or other factors such as allergic reactions, immune complex mediated reactions -local, Immune complex mediated reactions-systemic which will be expressed as the number of events per infusion and per participant-year will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Treatment-Emergent Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions, Regardless of Causality
Description
Causality is a determination of whether there is a reasonable possibility that the IP is etiologically related to/associated with the AE. Number of treatment-emergent serious adverse events (SAEs) and/or adverse events (AEs) associated with infusions, regardless of causality will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Causally Related Serious Adverse Events (SAEs) and/or Adverse Events (AEs) Associated with Infusions
Description
Number of causally related serious adverse events (SAEs) and/or adverse events (AEs) associated with infusions will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Adverse Events (AEs) Temporally Associated with Infusions
Description
Number of AEs temporally associated with infusions defined as AEs occurring during or within 72 hours after completion of an infusion will be assessed.
Time Frame
During or within 72 hours after completion of an infusion
Title
Number of Serious and/or Non-Serious Adverse Reactions (ARs) Plus Suspected Adverse Reactions (ARs) Associated with Infusions
Description
Number of serious and/or non-serious ARs plus suspected ARs associated with infusions will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Infusions Associated with One or More Systemic Adverse Events (AEs)
Description
Number of infusions associated with 1 or more systemic AEs will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Infusions Associated with One or More Local Infusion Site Reactions
Description
Number of infusions associated with 1 or more local infusion site reactions will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
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
Number of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Rates of Systemic and local Adverse Events (AEs), Regardless of Causality
Description
Rates of systemic and local AEs, regardless of causality will be expressed as number of events per infusion, per participant, and per participant-year.
Time Frame
Throughout the study period of approximately 7 years
Title
Rates of Causally Related Systemic and Local Adverse Events (AEs)
Description
Rates of causally related systemic and local AEs, will be expressed as number of events per infusion, per participant, and per participant-year.
Time Frame
Throughout the study period of approximately 7 years
Title
Rates of Systemic and Local Adverse Reactions (ARs) plus Suspected Adverse Reactions (ARs)
Description
Rates of systemic and local adverse reactions (ARs) plus suspected ARs, will be expressed as number of events per infusion, per participant, and per participant-year.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Participants with an Adverse Event (AE) that led to Discontinuation from Study
Description
Number of participants with an adverse event (AE) that led to discontinuation from study will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Moderate or Severe Adverse Events (AEs) that may be a Result of Immune-Mediated Responses
Description
Number of moderate or severe adverse events (AEs) that may be a result of immune-mediated responses will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Rate per Infusion of Moderate or Severe Adverse Events (AEs) that may be a Result of Immune-Mediated Responses
Description
Rate per infusion of moderate or severe adverse events (AEs) that may be a result of immune-mediated responses will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Participants Experiencing Treatment-Emergent Local Infusion Site Reactions
Description
Number of participants experiencing treatment-emergent local infusion site reactions will be assessed. All local infusion site treatment-emergent AEs will be reported as adverse reactions.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Participants with Treatment-Emergent with Local Tolerability Events
Description
Number of participants with treatment-emergent with local tolerability events during the first 8 weeks of open-label extension study 161505 among participants originally randomized to placebo (no ramp up), versus during the 8 week-ramp-up period for participants originally randomized to HYQVIA in double-blind Study 161403 will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Participants in whom Infusion Rate was Reduced and/or the Infusion was Interrupted or Stopped due to Intolerability and/or Adverse Events (AEs)
Description
Number of participants in whom infusion rate was reduced and/or the infusion was interrupted or stopped due to intolerability and/or AEs will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Participants with Local Infusion Reactions, as a Function of Dosing Interval, Infusion Rate per Site, and Infusion Volume per Site
Description
Number of participants experiencing local infusion reactions, as a function of dosing interval, infusion rate per site, and infusion volume per site will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Participants whose Anti-Hyaluronidase Antibody Titers Rise by Greater Than or Equal (> or =) ( 4 Fold from the Original Baseline Value from Study 161403 Using Combined Data from Both Studies (161403 and 161505)
Description
Number of participants whose anti-hyaluronidase antibody titers rise by > or = 4 fold from the original baseline value from study 161403 using combined data from both studies (161403 and 161505) will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Incidence of Binding Antibodies to rHuPH20
Description
Incidence of binding antibodies to rHuPH20 will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Incidence of Neutralizing Antibodies to rHuPH20
Description
Incidence of neutralizing antibodies to rHuPH20 will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Participants with a Decline of Anti-rHuPH20 Antibody Titers to the Antibody Titer Level at Baseline in Study 161403 or Study 161601 and/or to Less than (<)160 at the Study Completion or Early Discontinuation
Description
Number of participants with a decline of anti-rHuPH20 antibody titers to the antibody titer level at baseline in Study 161403 or Study 161601 and/or to <160 at the study completion or early discontinuation will be assessed.
Time Frame
Throughout the study period of approximately 7 years
Title
Number of Participants who have Greater than (>) 10,000 Titer of Binding Antibodies to rHuPH20: Neutralizing Antibodies and Cross Reactivity with Hyal-1,2 and 4
Description
Number of participants who have >10,000 titer of binding antibodies to rHuPH20: neutralizing antibodies and cross reactivity with Hyal-1,2 and 4 will be assessed.
Time Frame
Throughout the study period of approximately 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has completed Epoch 1 of Study 161403 without CIDP worsening. If female of childbearing potential, the participant must have a negative pregnancy test at baseline and agree to employ adequate birth control measures (eg, birth control pills/patches, intrauterine device, or diaphragm or condom [for male partner] with spermicidal jelly or foam) throughout the course of the study. Exclusion Criteria: Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this Extension Study. New medical condition that developed during participation in study 161403 that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of investigational medicinal product (IMP) and/or conduct of the study. Participant is scheduled to participate in another non-Baxalta clinical study involving an IP or investigational device during the course of this 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 investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study (with the exception of study 161403) involving an IP or investigational device during the course of this study. The participant is a family member or employee of the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Neuromuscular Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Hosp.Britanico de Buenos Aires
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
1280
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
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, University Health Network
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
050010
Country
Colombia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
State/Province
Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Prague 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Århus Universitetshospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
CHU de Nice
City
Nice
State/Province
Alpes Maritimes
ZIP/Postal Code
06002
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
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
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
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 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
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
Fakultna nemocnica Nitra
City
Nitra
ZIP/Postal Code
95001
Country
Slovakia
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pamukkale Uni. Med. Fac.
City
Denizli
ZIP/Postal Code
20070
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
45030
Country
Turkey
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/5f6b5fc54db2bf003ab45c9a
Description
To obtain more information on the study, click here/on this link

Learn more about this trial

Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP

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