NCT04842643

An Extension Study of TAK-664 for Japanese People With Primary Immunodeficiency Disease

A Phase 3, Open-label, Non-controlled, Multi-dose, Extension Study to Evaluate the Long-term Safety and Tolerability of IGSC, 20% in Japanese Subjects With Primary Immunodeficiency Disease (PID)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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 be about to complete it before joining this study. Participants will continue treatment with IGCS, 20% in this study. The main aim of this study is to check for side effects from long-term treatment with IGSC, 20% . This medicine is not yet licensed in Japan, so participants will be treated with IGSC, 20% until it becomes commercially available.

Conditions

• Primary Immunodeficiency Disease

Interventions

Type	Name	Description
BIOLOGICAL	IGSC 20% infusion	IGSC 20% infusion,

Timeline

• Start date: 2021-04-27
• Primary completion: 2024-04-25
• Completion: 2024-04-25
• First posted: 2021-04-13
• Last updated: 2025-01-20
• Results posted: 2025-01-20

Locations

8 sites across 1 country: Japan