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A Study of Freeze-dried Human Protein C Concentrate (TAK-662) in Participants With Congenital Protein C Deficiency
Sponsor: Takeda
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.
Official title: Special Drug Use Surveillance Study of Ceprotin for Intravenous Injection 1000IU (All-Case Surveillance)
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
7
Start Date
2024-09-06
Completion Date
2030-06-30
Last Updated
2025-08-26
Healthy Volunteers
No
Conditions
Interventions
Freeze-dried Human Protein C Concentrate
Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection
Locations (1)
Takeda selected site
Tokyo, Tokyo, Japan