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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06590974

Enrollment

Registered

2024-09-19

Start date

2024-09-06

Completion date

2030-06-30

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein C Deficiency

Keywords

Ceprotin/Protein C Deficiency

Brief 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.

Interventions

DRUGFreeze-dried Human Protein C Concentrate

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- None

Design outcomes

Primary

Measure	Time frame
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)	Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)

Secondary

Measure	Time frame
Number of Participants who Experience at Least One TEAE of Venous Thromboembolism	Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)
Number of Participants who Experience at Least One TEAE of Purpura Fulminans	Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum)

Countries

Japan

Contacts

CONTACTTakeda Contact

medinfoUS@takeda.com+1-877-825-3327

STUDY_DIRECTORStudy Director

Takeda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026