NCT06590974

A Study of Freeze-dried Human Protein C Concentrate (TAK-662) in Participants With Congenital Protein C Deficiency

Special Drug Use Surveillance Study of Ceprotin for Intravenous Injection 1000IU (All-Case Surveillance)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 7 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is conducted in Japan of Freeze-dried Human Protein C Concentrate (TAK-662) used to treat participants with congenital protein C deficiency. The main aim of the study is to evaluate for adverse events and effectiveness of congenital protein C deficiency (TAK-662). During the study, participants with congenital protein C deficiency will be administered with TAK-662 intravenous injection in under routine normal practice. The investigators will evaluate adverse events due to TAK-662 for 12 months. For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, the investigator will evaluate for 24 months as a maximum. The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study.

Conditions

• Protein C Deficiency

Interventions

Type	Name	Description
DRUG	Freeze-dried Human Protein C Concentrate	Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection

Timeline

• Start date: 2024-09-06
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2024-09-19
• Last updated: 2025-08-26

Locations

1 site across 1 country: Japan