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

JRCT ID: jRCT2031240322

Registered date:05/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Congenital Protein C Deficiency
• Date of first enrollment: 06/09/2024
• Target sample size: 7
• Study type: Observational

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 1.All participants with congenital protein C deficiency who are administered therapy with Freeze-dried Human Protein C Concentrate (TAK-662).
• Exclude criteria: none

Related Information

• Primary Sponsor: Contact for Clinical Trial Information
• Secondary ID(s): NCT06590974