An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease
Primary Immunodeficiency Disease
About this trial
This is an interventional treatment trial for Primary Immunodeficiency Disease
Eligibility Criteria
Inclusion Criteria:
Participant has completed or is about to complete Takeda Clinical Study TAK-664-3001.
A participant is considered to have completed Study TAK-664-3001 successfully if they fulfill the following criterion: Completed Epoch 2, in which IGSC, 20% is administered weekly (completion of Epoch 3, in which IGSC, 20% is administered biweekly, is not mandatory for participation in TAK-664-3002 study).
- Written 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.
- Participant is willing and able to comply with the requirements of the protocol.
Exclusion Criteria:
- Participant has developed a new serious medical condition during participation in Study TAK-664-3001 such that the Participant's safety or medical care would be impacted by participation in the extension study TAK-664-3002.
- Participant is scheduled to participate in another non-Takeda clinical study involving an Investigational Product or investigational device in the course of this study.
- If a female of childbearing potential, Participant is pregnant or has a negative pregnancy test but does not agree to employ adequate birth control measures for the duration of the study.
Sites / Locations
- Nagoya University Hospital
- Kurume University Hospital
- Kanazawa University Hospital
- National defense medical college Hospital
- Kyushu University Hospital
- Gifu University Hospital
- Hiroshima University Hospital
- Tokyo Medical Dental University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Epoch 2 in previous study: Immune Globulin Subcutaneous 20% Solution (IGSC)
Epoch 3 in previous study: Immune Globulin Subcutaneous 20% Solution (IGSC)
Participants will receive between 50 and 200 mg/kg of Immunoglobulin Globulin subcutaneous (IGSC) infusion, 20 percent (%) once a week until the study drug becomes commercially available (approximately 3 years). All participants of this arm will have assigned Epoch 2 of previous study (TAK-664-3001). The dose of IGSC will be established in previous study.
Participants will receive between 100 and 400 mg/kg of Immunoglobulin Globulin subcutaneous (IGSC) infusion, 20 percent (%) once every 2 weeks until the study drug becomes commercially available (approximately 3 years). All participants of this arm will have assigned Epoch 3 of previous study (TAK-664-3001).The dose of IGSC will be established in previous study (TAK-664-3001). For participants who discontinue Epoch 3 and enter Study TAK-664-3002, the dose regimen will be determined on a case-by-case basis.