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Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP

Immune Thrombocytopenia Clinical Trial

Official title:
An Open-label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic Immune Thrombocytopenia

Clinical Trial Summary

Evaluate the efficacy, safety, and PK of avatrombopag given for 26 weeks in Japanese adults with chronic immune thrombocytopenia (ITP).

Clinical Trial Description

This Phase 3, multicenter, open label study will evaluate the efficacy, safety, and population pharmacokinetics (PK) of avatrombopag in Japanese adults with chronic ITP. At least 19 subjects will be enrolled. The study will consist of 3 phases: Pre-enrollment, Primary Investigation, and Extension Phase until market authorization in Japan. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05369208
Study type Interventional
Source Sobi, Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 15, 2022
Completion date August 31, 2025
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See also
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