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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Hospital of University of Occupational and Environmental Health
Kitakyushu, Fukuoka, Japan
Gifu University Hospital
Gifu, Gifu, Japan
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.
Time frame: Up to 3 years
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
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Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Kanagawa Children's Medical Center
Yokohama, Kanagawa, Japan
Saitama Prefectual Children's Medical Center
Saitama, Saitama, Japan
Shizuoka Childrens Hospital
Shizuoka, Shizuoka, Japan
Tokyo Medical Dental University Hospital
Bunkyo-ku, Tokyo, Japan