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
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
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
An Adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including a clinically significant laboratory finding), symptom, or disease temporally associated with the use of a investigational product, whether or not causality is suspected. A TEAE was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product.
Time frame: From start of study drug administration up to end of study (up to 3.1 years)
Percentage of Participants Who Developed Anti-rHuPH20 Binding Antibody Titers of >=1:160 and Neutralizing Antibodies to rHuPH20
Participants who developed anti-rHuPH20 binding antibody titers of \>=1:160 and neutralizing antibodies to rHuPH20 was reported.
Time frame: From start of study drug administration up to end of study (up to 3.1 years)
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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