At a glance
ClinicalIndex Comparison Record- ✓Completed or about to complete Study TAK-771-3004 (NCT05150340)
- ✓Willing and able to comply with protocol requirements
- ✓Written and/or electronic informed consent obtained (parent/guardian consent if <18 years)
- ✕Serious medical condition developed during prior study that would impact safety or medical care
- ✕Women of childbearing potential with positive pregnancy test
- ✕Women of childbearing potential unwilling to use adequate birth-control measures
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating TAK-771 for Primary Immunodeficiency Diseases (PID). Completed, enrolled 15 participants across 9 sites.
Detailed 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.
Study Details
Timeline
Interventions
Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)