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A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases

Primary Purpose

Primary Immunodeficiency Diseases (PID)

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TAK-881
HYQVIA
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immunodeficiency Diseases (PID) focused on measuring Immunoglobulin replacement therapy; facilitated subcutaneous, Immunoglobulin; primary immunodeficiency disease

Eligibility Criteria

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

Inclusion Criteria Participant must have a documented diagnosis of a form of primary humoral immunodeficiency involving a defect in antibody formation and requiring immunoglobulin (IgG) replacement, as defined according to the International Union of Immunological Societies (IUIS) Committee. Participant is 2 years to <16 years at the time of signing the informed consent form (ICF) for the single arm treatment part of the study OR 16 years or older at the time of signing the ICF for the crossover part of the study. Participant has received regular intravenous immune globulin (IVIG) or HYQVIA with a treatment interval of every 21 or 28 days over a period of at least 12 weeks prior to screening at a minimum dose of 0.3 grams per kilograms per body weight per 4 weeks (g/kg BW/4 weeks). Variations in the treatment interval of up to ±5 days are acceptable. Participant has a serum trough level of IgG greater than (>) 5 grams per liter (g/L) at screening (sample taken prior to last prestudy IgG infusion and after signing the ICF). If female of childbearing potential, participant presents with a negative pregnancy test and agrees to employ an acceptable form of contraception for the duration of the study. Participant/Parent/Legal Guardian is willing and able to comply with the requirements of the protocol. Informed Consent The participant or the participant's parent/legal guardian is willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator. The participant / Participant's parent/legal guardian has provided informed consent/assent, if applicable, (that is, in writing, documented via a signed and dated ICF and/or eConsent, if available), and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria Participant has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2. Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent): Persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5* the upper limit of normal (ULN) for the testing laboratory. Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] less than and equal to (<=) 500 per cubic millimeter (/mm^3). 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). Participant has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator. Participant has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IV immunoglobulin, SC immunoglobulin, and/or immune serum globulin infusions. Known substance or prescription drug abuse within 12 months of screening. Participant has immunoglobulin A (IgA) deficiency (IgA less than 0.07 g/L) with known anti-IgA antibodies and a history of hypersensitivity. Participant has a known allergy to hyaluronidase. Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening. Participant has a bleeding disorder, or a platelet count less than 20,000 per microliter (mcL), or in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of immune globulin subcutaneous (IGSC) therapy. History or current diagnosis of thrombotic episodes; venous thrombus that occurred in association with a medical device >2 years prior to screening are allowed. Participant has severe dermatitis that would preclude adequate sites for safe product administration in the opinion of the investigator. Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening. Participant is scheduled to participate in another clinical study involving an IP (except for participants scheduled to enroll in a long-term follow-up study with TAK-881) or investigational device during the course of this study. Participant is a family member or employee of the investigator or the investigator's site staff. If female, participant is pregnant or lactating at the time of screening.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Randomized Crossover Treatment Epoch: TAK-881 followed by HYQVIA (Sequence 1)

    Randomized Crossover Treatment Epoch: HYQVIA followed by TAK-881 (Sequence 2)

    Single Arm Treatment Epoch: TAK-881

    Arm Description

    Participants aged >=16 years will receive 6 or 8 full doses of TAK-881 followed by 6 or 8 full doses HYQVIA in sequence 1. The first full dose of TAK-881 will be administered either 2 weeks after the second ramp-up dose (if applicable) or 3 or 4 weeks after the last infusion of their pre study immunoglobulin G (IgG) treatment (if ramp-up is not applicable).

    Participants aged >=16 years will receive 6 or 8 full doses of HYQVIA followed by 6 or 8 full doses of TAK-881 in Sequence 2. The first full dose of HYQVIA will be administered either 2 weeks after the second ramp-up dose (if applicable) or 3 or 4 weeks after the last infusion of their pre study IgG treatment (if ramp-up is not applicable).

    Pediatric participants aged 2 to <16 years will receive 6 or 8 full doses of TAK-881. The first full dose of TAK-881, will be administered either 2 weeks after the second ramp-up dose (if applicable) or 3 or 4 weeks after the last infusion of their pre study IgG treatment (if ramp-up is not applicable).

    Outcomes

    Primary Outcome Measures

    Area Under the Curve During the Dosing Interval at Steady-State (AUC0-tau;ss) of total IgG with TAK-881 and HYQVIA in Participants Aged >=16 Years with PIDD

    Secondary Outcome Measures

    Annualized Rate of all Infections in Participants
    Annualized Rate of Acute Serious Bacterial Infections (ASBIs) in Participants
    Annualized Rate of Episodes of Fever in Participants
    Time to First ASBI in Participants
    Duration of Infections in Participants
    Number of Days Lost From School, Work, Daycare, or to Perform Normal Daily Activities Due To Infection and/or their treatment or other Illnesses (non-Infection)
    Number of Days on Antibiotics in Participants
    Number of Hospitalizations With Indications (Infection or other Illnesses)
    Number of Days of Hospitalization
    Number of Acute Physician Visits (Office and Emergency Room) Due to Infection or Other Illnesses
    Maximum Concentration (Cmax) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD
    Time to Maximum Concentration (Tmax) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD
    Terminal half-life (t1/2) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD
    Apparent Clearance (CL/F) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD
    Apparent Volume of Distribution (Vz/F) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD
    AUC0-tau; ss Per Week (AUC0-tau; ss/week) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 years with PIDD
    Maximum Concentration (Cmax) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    Time to Maximum Concentration (Tmax) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    Terminal half-life (t1/2) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    Apparent Clearance (CL/F) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    Apparent Volume of Distribution (Vz/F) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    AUC0-tau; ss Per Week (AUC0-tau; ss/week) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    Trough Level of Total IgG in Participants Aged 2 to <16 Years and >=16 Years with PIDD
    Trough Level of IgG Subclasses in Participants Aged 2 to <16 Years and >=16 Years with PIDD
    Trough Level of Antigen Specific IgG Antibodies in Participants Aged 2 to <16 Years and >=16 Years with PIDD
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
    Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs
    Number of Participants With Positive Binding Antibodies (Titer Greater than and equal to [>=] 1:160) and With Positive Neutralizing Antibodies to rHuPH20
    Number of Infusions per Month at Full Dose With Both TAK-881 and HYQVIA in all Participants
    Duration of Infusions (minutes) at Full Dose With Both TAK-881 and HYQVIA in all Participants
    Monthly Infusion (minutes/month) Time at Full Dose With Both TAK-881 and HYQVIA in all Participants
    Number of Infusions Sites (Needle Sticks) per Infusion at Full Dose With Both TAK-881 and HYQVIA in all Participants
    Number of Infusions Sites (Needle Sticks) per Month at Full Dose With Both TAK-881 and HYQVIA in all Participant
    Maximum Infusion Rate per Site (mL/hour/site) at Full Dose With Both TAK-881 and HYQVIA in all Participants
    Infusion Volume per Site (mL/site) at Full Dose With Both TAK-881 and HYQVIA in all Participants

    Full Information

    First Posted
    January 26, 2023
    Last Updated
    September 22, 2023
    Sponsor
    Takeda
    Collaborators
    Takeda Development Center Americas, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05755035
    Brief Title
    A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
    Official Title
    Multicenter, Prospective, Open-label, Randomized, Crossover Study to Evaluate Pharmacokinetics (PK), Safety, and Tolerability of TAK-881 in Primary Immunodeficiency Diseases (PIDD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 30, 2023 (Anticipated)
    Primary Completion Date
    February 10, 2026 (Anticipated)
    Study Completion Date
    September 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Takeda
    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 main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16 years old and older. The participants will be treated with TAK-881/HYQVIA or HYQVIA/TAK-881 with the same dose and dosing interval of immunoglobulin for up to 51 weeks (for participants greater than or equal to [>=]16 years) and only with TAK-881 for up to 27 weeks (for participants aged 2 to less than [<]16 years) as they were treated with another immunoglobulin before enrollment. Participants will need to visit the clinic every 3 or 4 weeks during the duration of the study.
    Detailed Description
    The study consists of a screening epoch, a ramp-up epoch (if needed) and treatment epochs. Participants who have been receiving intravenous IgG (IVIG) before the study, will enter a ramp-up epoch which will start 3 or 4 weeks after the last IVIG pre study dose before screening. Participants who have already been receiving HYQVIA treatment before the study, will directly enter the treatment epochs after screening. Participants aged greater than or equal to [>=]16 years will be randomized at a 1:1 ratio to one of the following treatment sequences: either TAK-881 followed by HYQVIA or HYQVIA followed by TAK-881. Each participant aged greater than or equal to [>=]16 years will complete both crossover epochs. Pediatric participants aged 2 to less than [<]16 years will complete a single arm treatment with the study drug (TAK-881 only).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Immunodeficiency Diseases (PID)
    Keywords
    Immunoglobulin replacement therapy; facilitated subcutaneous, Immunoglobulin; primary immunodeficiency disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Crossover Assignment
    Model Description
    This study consists of crossover randomized epoch (participants aged >=16 years) and single arm epoch (participants aged 2 to <16 years).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    71 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Randomized Crossover Treatment Epoch: TAK-881 followed by HYQVIA (Sequence 1)
    Arm Type
    Experimental
    Arm Description
    Participants aged >=16 years will receive 6 or 8 full doses of TAK-881 followed by 6 or 8 full doses HYQVIA in sequence 1. The first full dose of TAK-881 will be administered either 2 weeks after the second ramp-up dose (if applicable) or 3 or 4 weeks after the last infusion of their pre study immunoglobulin G (IgG) treatment (if ramp-up is not applicable).
    Arm Title
    Randomized Crossover Treatment Epoch: HYQVIA followed by TAK-881 (Sequence 2)
    Arm Type
    Experimental
    Arm Description
    Participants aged >=16 years will receive 6 or 8 full doses of HYQVIA followed by 6 or 8 full doses of TAK-881 in Sequence 2. The first full dose of HYQVIA will be administered either 2 weeks after the second ramp-up dose (if applicable) or 3 or 4 weeks after the last infusion of their pre study IgG treatment (if ramp-up is not applicable).
    Arm Title
    Single Arm Treatment Epoch: TAK-881
    Arm Type
    Experimental
    Arm Description
    Pediatric participants aged 2 to <16 years will receive 6 or 8 full doses of TAK-881. The first full dose of TAK-881, will be administered either 2 weeks after the second ramp-up dose (if applicable) or 3 or 4 weeks after the last infusion of their pre study IgG treatment (if ramp-up is not applicable).
    Intervention Type
    Biological
    Intervention Name(s)
    TAK-881
    Other Intervention Name(s)
    Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20).
    Intervention Description
    Participants will receive SC infusion of TAK-881.
    Intervention Type
    Biological
    Intervention Name(s)
    HYQVIA
    Other Intervention Name(s)
    Immune Globulin Infusion (Human), 10% Solution with Recombinant Human Hyaluronidase (rHuPH20).
    Intervention Description
    Participants will receive SC infusion of HYQVIA.
    Primary Outcome Measure Information:
    Title
    Area Under the Curve During the Dosing Interval at Steady-State (AUC0-tau;ss) of total IgG with TAK-881 and HYQVIA in Participants Aged >=16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch
    Secondary Outcome Measure Information:
    Title
    Annualized Rate of all Infections in Participants
    Time Frame
    Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)
    Title
    Annualized Rate of Acute Serious Bacterial Infections (ASBIs) in Participants
    Time Frame
    Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)
    Title
    Annualized Rate of Episodes of Fever in Participants
    Time Frame
    Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)
    Title
    Time to First ASBI in Participants
    Time Frame
    Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)
    Title
    Duration of Infections in Participants
    Time Frame
    Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)
    Title
    Number of Days Lost From School, Work, Daycare, or to Perform Normal Daily Activities Due To Infection and/or their treatment or other Illnesses (non-Infection)
    Time Frame
    Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)
    Title
    Number of Days on Antibiotics in Participants
    Time Frame
    Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)
    Title
    Number of Hospitalizations With Indications (Infection or other Illnesses)
    Time Frame
    Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)
    Title
    Number of Days of Hospitalization
    Time Frame
    Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)
    Title
    Number of Acute Physician Visits (Office and Emergency Room) Due to Infection or Other Illnesses
    Time Frame
    Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)
    Title
    Maximum Concentration (Cmax) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch
    Title
    Time to Maximum Concentration (Tmax) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch
    Title
    Terminal half-life (t1/2) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch
    Title
    Apparent Clearance (CL/F) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch
    Title
    Apparent Volume of Distribution (Vz/F) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch
    Title
    AUC0-tau; ss Per Week (AUC0-tau; ss/week) of total IgG with TAK-881 and HYQVIA at Steady-State in Participants Aged >=16 years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 14, 21, 28 days (post-infusion) of last infusion in each cross-over epoch
    Title
    Maximum Concentration (Cmax) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)
    Title
    Time to Maximum Concentration (Tmax) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)
    Title
    Terminal half-life (t1/2) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)
    Title
    Apparent Clearance (CL/F) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)
    Title
    Apparent Volume of Distribution (Vz/F) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)
    Title
    AUC0-tau; ss Per Week (AUC0-tau; ss/week) of TAK-881 at Steady-State in Participants Aged 2 to <= 16 Years with PIDD
    Time Frame
    3-Week dosing: Day 1 (pre and post-infusion), 24, 48, 72 hours and 7, 14, 21 days (post-infusion); 4-Week dosing: Day 1 (pre and post-infusion), 24, 48 and 72 hours and 7, 21, 28 days (post-infusion)
    Title
    Trough Level of Total IgG in Participants Aged 2 to <16 Years and >=16 Years with PIDD
    Time Frame
    Up to 27 Weeks (2 to <16 years) and 51 Weeks (>=16 years)
    Title
    Trough Level of IgG Subclasses in Participants Aged 2 to <16 Years and >=16 Years with PIDD
    Time Frame
    Up to 27 Weeks (2 to <16 years) and 51 Weeks (>=16 years)
    Title
    Trough Level of Antigen Specific IgG Antibodies in Participants Aged 2 to <16 Years and >=16 Years with PIDD
    Time Frame
    Up to 27 Weeks (2 to <16 years) and 51 Weeks (>=16 years)
    Title
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
    Time Frame
    Up to 28 Weeks (2 to <16 years) and 52 Weeks (>=16 years)
    Title
    Number of Participants With Infusion Withdrawals, Interruptions, and Infusion Rate Reductions due to TAK-881-related TEAEs
    Time Frame
    From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)
    Title
    Number of Participants With Positive Binding Antibodies (Titer Greater than and equal to [>=] 1:160) and With Positive Neutralizing Antibodies to rHuPH20
    Time Frame
    From start of study drug administration, up to 25 Week (2 to <16 years) and 49 Week (>=16 years)
    Title
    Number of Infusions per Month at Full Dose With Both TAK-881 and HYQVIA in all Participants
    Time Frame
    From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)
    Title
    Duration of Infusions (minutes) at Full Dose With Both TAK-881 and HYQVIA in all Participants
    Time Frame
    From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)
    Title
    Monthly Infusion (minutes/month) Time at Full Dose With Both TAK-881 and HYQVIA in all Participants
    Time Frame
    From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)
    Title
    Number of Infusions Sites (Needle Sticks) per Infusion at Full Dose With Both TAK-881 and HYQVIA in all Participants
    Time Frame
    From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)
    Title
    Number of Infusions Sites (Needle Sticks) per Month at Full Dose With Both TAK-881 and HYQVIA in all Participant
    Time Frame
    From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)
    Title
    Maximum Infusion Rate per Site (mL/hour/site) at Full Dose With Both TAK-881 and HYQVIA in all Participants
    Time Frame
    From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)
    Title
    Infusion Volume per Site (mL/site) at Full Dose With Both TAK-881 and HYQVIA in all Participants
    Time Frame
    From start of study drug administration, up to 22 Week (2 to <16 years) and 46 Week (>=16 years)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Participant must have a documented diagnosis of a form of primary humoral immunodeficiency involving a defect in antibody formation and requiring immunoglobulin (IgG) replacement, as defined according to the International Union of Immunological Societies (IUIS) Committee. Participant is 2 years to <16 years at the time of signing the informed consent form (ICF) for the single arm treatment part of the study OR 16 years or older at the time of signing the ICF for the crossover part of the study. Participant has received regular intravenous immune globulin (IVIG) or HYQVIA with a treatment interval of every 21 or 28 days over a period of at least 12 weeks prior to screening at a minimum dose of 0.3 grams per kilograms per body weight per 4 weeks (g/kg BW/4 weeks). Variations in the treatment interval of up to ±5 days are acceptable. Participant has a serum trough level of IgG greater than (>) 5 grams per liter (g/L) at screening (sample taken prior to last prestudy IgG infusion and after signing the ICF). If female of childbearing potential, participant presents with a negative pregnancy test and agrees to employ an acceptable form of contraception for the duration of the study. Participant/Parent/Legal Guardian is willing and able to comply with the requirements of the protocol. Informed Consent The participant or the participant's parent/legal guardian is willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator. The participant / Participant's parent/legal guardian has provided informed consent/assent, if applicable, (that is, in writing, documented via a signed and dated ICF and/or eConsent, if available), and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria Participant has a known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for hepatitis C virus (HCV), PCR for human immunodeficiency virus (HIV) Type 1/2. Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent): Persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5* the upper limit of normal (ULN) for the testing laboratory. Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] less than and equal to (<=) 500 per cubic millimeter (/mm^3). 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). Participant has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site, at the discretion of the investigator. Participant has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IV immunoglobulin, SC immunoglobulin, and/or immune serum globulin infusions. Known substance or prescription drug abuse within 12 months of screening. Participant has immunoglobulin A (IgA) deficiency (IgA less than 0.07 g/L) with known anti-IgA antibodies and a history of hypersensitivity. Participant has a known allergy to hyaluronidase. Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening. Participant has a bleeding disorder, or a platelet count less than 20,000 per microliter (mcL), or in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of immune globulin subcutaneous (IGSC) therapy. History or current diagnosis of thrombotic episodes; venous thrombus that occurred in association with a medical device >2 years prior to screening are allowed. Participant has severe dermatitis that would preclude adequate sites for safe product administration in the opinion of the investigator. Participant has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to screening. Participant is scheduled to participate in another clinical study involving an IP (except for participants scheduled to enroll in a long-term follow-up study with TAK-881) or investigational device during the course of this study. Participant is a family member or employee of the investigator or the investigator's site staff. If female, participant is pregnant or lactating at the time of screening.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Takeda Contact
    Phone
    +1-877-825-3327
    Email
    medinfoUS@takeda.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Study Director
    Organizational Affiliation
    Takeda
    Official's Role
    Study Director

    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/93ce00d8c19e4041?idFilter=%5B%22TAK-881-3001
    Description
    To obtain more information on the study, click here/on this link

    Learn more about this trial

    A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases

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