Back to resultsA Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants
Primary Purpose
Primary Immunodeficiency Diseases (PID)
Status
Active
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TAK-771
Sponsored by
About this trial
This is an interventional treatment trial for Primary Immunodeficiency Diseases (PID)
Eligibility Criteria
Inclusion Criteria:
- Participant have completed or is about to complete Study TAK-771-3004 (NCT05150340).
- Written and/or electronic informed consent is obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration. If a participant is <18 years of age, written and/or electronic informed consent should also be obtained from the participant's legally authorized representative in addition to written informed assent by a participant if appropriate.
- Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
- Participant has developed a new serious medical condition during Study TAK-771-3004 such that the participant's safety or medical care would be impacted by participation in the study.
- Participant is willing to participate in other clinical trials.
Women of childbearing potential who meet any one of the following criteria:
- Participant presents with a positive pregnancy test.
- Participant does not agree to employ adequate birth-control measures (eg, intrauterine device, condom [for male partner], or birth-control pills) throughout the course of the study.
Sites / Locations
- Nagoya University Hospital
- Hospital of University of Occupational and Environmental Health
- Kanagawa Children's Medical Center
- Tokyo Medical Dental University Hospital
- Kyushu University Hospital
- Gifu University Hospital
- Hiroshima University Hospital
- Saitama Prefectual Children's Medical Center
- Shizuoka Childrens Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAK-771
Arm Description
TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution.
Outcomes
Primary Outcome Measures
Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
TEAEs are defined as AEs with onset after date-time of first dose of investigational drug or medical conditions present prior to the start of investigational drug but increased in severity or relationship after date-time of first dose of investigational drug.
Percentage of Participants who Develop Anti-rHuPH20 Binding Antibody Titers of Greater Than or Equal to 1:160 and who Develop Neutralizing Antibodies to rHuPH20
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05513586
Brief Title
A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants
Official Title
A Phase 3, Open-label, Non-controlled, Extension Study to Evaluate the Long-term Safety of TAK-771 in Japanese Patients With Primary Immunodeficiency Disease (PID)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main aim of the study is to check side effect from the study treatment with TAK-771 in long term.
Participants can have taken part in the previous study TAK-771-3004 (NCT05150340). For those who can take part, the participants will receive injections of TAK-771 after the end of the previous study. The participants will be treated with TAK-771 for totally 3 years.
There will be many clinic visits. The number of visits will depend on the infusion cycles of study drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immunodeficiency Diseases (PID)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAK-771
Arm Type
Experimental
Arm Description
TAK-771 includes Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20). Participants will receive SC infusion of rHuPH20 solution at a dose of 80 U/g IgG first, followed by SC infusion of 10% IGI within 10 minutes of completion of the infusion of rHuPH20 solution.
Intervention Type
Drug
Intervention Name(s)
TAK-771
Other Intervention Name(s)
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
Intervention Description
Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)
Primary Outcome Measure Information:
Title
Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
Description
TEAEs are defined as AEs with onset after date-time of first dose of investigational drug or medical conditions present prior to the start of investigational drug but increased in severity or relationship after date-time of first dose of investigational drug.
Time Frame
Up to 3 years
Title
Percentage of Participants who Develop Anti-rHuPH20 Binding Antibody Titers of Greater Than or Equal to 1:160 and who Develop Neutralizing Antibodies to rHuPH20
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant have completed or is about to complete Study TAK-771-3004 (NCT05150340).
Written and/or electronic informed consent is obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration. If a participant is <18 years of age, written and/or electronic informed consent should also be obtained from the participant's legally authorized representative in addition to written informed assent by a participant if appropriate.
Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
Participant has developed a new serious medical condition during Study TAK-771-3004 such that the participant's safety or medical care would be impacted by participation in the study.
Participant is willing to participate in other clinical trials.
Women of childbearing potential who meet any one of the following criteria:
Participant presents with a positive pregnancy test.
Participant does not agree to employ adequate birth-control measures (eg, intrauterine device, condom [for male partner], or birth-control pills) throughout the course of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Hospital of University of Occupational and Environmental Health
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Kanagawa Children's Medical Center
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Tokyo Medical Dental University Hospital
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan
Facility Name
Gifu University Hospital
City
Gifu
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
Country
Japan
Facility Name
Saitama Prefectual Children's Medical Center
City
Saitama
Country
Japan
Facility Name
Shizuoka Childrens Hospital
City
Shizuoka
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).
Links:
URL
https://clinicaltrials.takeda.com/study-detail/972f9fef5a9d434a
Description
To obtain more information on the study, click here/on this link
Learn more about this trial
A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants
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