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

Recruiting

• Conditions: Protein C Deficiency
• Interventions: Drug: Freeze-dried Human Protein C Concentrate

• Registration Number: NCT06590974
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-05
• Study Start: 2024-09-06
• Study First Posted: 2024-09-11
• Last Update Submitted: 2024-09-17
• Last Update Posted: 2024-09-19
• Primary Completion: 2030-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Freeze-dried Human Protein C Concentrate (TAK-662)	Freeze-dried Human Protein C Concentrate	Participants will be administered Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Takeda selected site; 🇯🇵 Tokyo, Japan