先天性プロテインC欠乏症の日本人患者を対象としたTAK-662の試験

基本情報

NCT ID

NCT04984889

ステータス

完了

試験のフェーズ

第1/第2相

試験タイプ

介入

目標被験者数

5

治験依頼者名

Takeda

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (4)