A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788

Summary

The purpose of this study is to investigate the efficacy, safety and pharmacokinetics of R788 compared with placebo, and to investigate the safety and efficacy of long term dosing of R788 in patients with chronic idiopathic thrombocytopenic purpura.

Timeline

Start

2019-12-24

Primary completion

2021-12-21

Completion

2023-09-25

Outcome

Met primary endpoint

registry analysis (superiority test); R788 Group vs Placebo Group; p = 0.030; Difference in Percent of Participants 36.4 (95% CI 3.1 to 59.3) NCT04132050 ↗

release “慢性特発性血小板減少性紫斑病を対象とした国内第Ⅲ相臨床試験第Ⅰ期の解析において主要評価項目を達成しましたことをお知らせいたします。” kissei.co.jp ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fostamatinib	Small molecule	—	Oral

Indications