NCT05513586

A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Immunodeficiency Diseases (PID)

Interventions

Type	Name	Description
DRUG	TAK-771	Immune Globulin Infusion (IGI) 10% and Recombinant Human Hyaluronidase (rHuPH20)

Timeline

• Start date: 2022-09-13
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2022-08-24
• Last updated: 2025-11-17

Locations

9 sites across 1 country: Japan