clinical trial · NCT05369208
Evaluation of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults With Chronic ITP
Sobi, Inc.·phase3·completed·n = 19
Immune ThrombocytopeniaAvatrombopag Oral Tablet
brief summary
Evaluate the efficacy, safety, and PK of avatrombopag given for 26 weeks in Japanese adults with chronic immune thrombocytopenia (ITP).
started
Jun 15, 2022
primary completion
Jan 17, 2024
completion
Oct 29, 2025
last updated
Jun 3, 2026
detailed 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.
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol