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

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.

Timeline

Start

2021-09-07

Primary completion

2022-03-29

Completion

2024-10-31

Publications

• Koh K, Nogami K, Kakuda H, Okimoto Y, Hino M, Tanigawara Y, Li Z, Suzuki C, Terashio S, Ueda H, Ohga S. A Phase 1/2, Open-Label, Single-Dose, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Human Plasma-Derived Protein C Concentrate in Japanese Patients with Severe Congenital Protein C Deficiency (SCPCD). J Blood Med. 2026 Mar 13;17:535025. doi: 10.2147/JBM.S535025. eCollection 2026.

Drugs

Indications