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Observational Study of Freeze-dried Human Protein C Concentrate TAK-662 Injection for Patients With Congenital Protein C Deficiency in Japan
Led by Takeda · Updated on 2026-07-31
7
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the use of Freeze-dried Human Protein C Concentrate TAK-662 for treating people with congenital protein C deficiency in Japan. The main goal is to assess adverse events and effectiveness of TAK-662 in managing this condition. This observational study records how TAK-662 is used under routine medical practice without involvement from the study sponsor. Participants will receive TAK-662 through intravenous injection during their usual care. The study observes participants receiving TAK-662 for an initial period of up to 12 months to evaluate adverse events. For those who continue with long-term supplementation after acute or short-term treatment, monitoring may extend up to 24 months to collect additional safety data. During the study, researchers will document adverse events including treatment-emergent effects and specific concerns like venous thromboembolism and purpura fulminans. Participants will be monitored regularly as part of their routine care, with safety and effectiveness tracked up to 24 months depending on treatment duration. The total participation time varies depending on the length of TAK-662 supplementation.
CONDITIONS
Brief Title
A Study of Freeze-dried Human Protein C Concentrate (TAK-662) in Participants With Congenital Protein C Deficiency
Research Team
T
Takeda Contact
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