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A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants
Sponsor: Takeda
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.
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)
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2022-09-13
Completion Date
2025-10-30
Last Updated
2026-05-19
Healthy Volunteers
No
Conditions
Interventions
TAK-771
Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)
Locations (9)
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Hospital of University of Occupational and Environmental Health
Kitakyushu, Fukuoka, Japan
Kanagawa Children's Medical Center
Yokohama, Kanagawa, Japan
Tokyo Medical Dental University Hospital
Bunkyo-ku, Tokyo, Japan
Kyushu University Hospital
Fukuoka, Japan
Gifu University Hospital
Gifu, Japan
Hiroshima University Hospital
Hiroshima, Japan
Saitama Prefectual Children's Medical Center
Saitama, Japan
Shizuoka Childrens Hospital
Shizuoka, Japan