NCT04984889

A Study of TAK-662 for Japanese Patients With Congenital Protein C Deficiency

An Open-Label, Single-Dose, Phase 1/2 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Human Protein C (TAK-662) for the Treatment of Congenital Protein C Deficiency in Japanese Subjects Followed by an Extension Part

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Pharmacokinetic Part: This study is for Japanese participants with congenital protein C deficiency. The main aim of this study is to check how much TAK-662 stays in their blood over time. This will help the study sponsor (Takeda) to work out the best dose to give patients in the future. Participants will receive 1 single infusion of TAK-662. They will stay at the clinic until 3 days after the infusion. Then, participants will return to their clinic 7 days after the infusion to check side effects from the study treatment. Extension Part: Participants who will complete the PK part will be given an opportunity to continue TAK-662 administration as 3 different treatment options (on-demand therapy, short-term prophylaxis, and long-term prophylaxis) in the Extension part, until the commercial protein C concentrate is available at each study site or study termination.

Conditions

• Congenital Protein C Deficiency

Interventions

Type	Name	Description
DRUG	TAK-662	Lyophilized, sterile concentrate of human protein C

Timeline

• Start date: 2021-09-07
• Primary completion: 2022-03-29
• Completion: 2024-10-31
• First posted: 2021-08-02
• Last updated: 2025-05-07
• Results posted: 2024-01-05

Locations

4 sites across 1 country: Japan