RecruitingNCT06590974

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)


Sponsor

Takeda

Enrollment

7 participants

Start Date

Sep 6, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Inclusion Criteria1

  • \- All participants with congenital protein C deficiency who are administered with Freeze-dried Human Protein C Concentrate (TAK-662).

Exclusion Criteria1

  • \- None

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Interventions

DRUGFreeze-dried Human Protein C Concentrate

Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection


Locations(1)

Takeda selected site

Tokyo, Tokyo, Japan

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NCT06590974