Status:
COMPLETED
An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease
Lead Sponsor:
Takeda
Conditions:
Primary Immunodeficiency Disease
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
This study is an extension study for participants with primary immunodeficiency disorders who were previously treated with IGSC, 20% in the TAK-664-3001 study. They must have completed that study or b...
Eligibility Criteria
Inclusion
- 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
- 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 device-used-in-clinical-trial 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.
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04842643
Start Date
April 27 2021
End Date
April 25 2024
Last Update
January 20 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
2
Kurume University Hospital
Kurume, Fukuoka, Japan
3
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
4
National defense medical college Hospital
Tokorozawa, Saitama, Japan