A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia

Summary

This is a phase 2, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag for Japanese subjects with thrombocytopenia associated with chronic liver disease. This study will assess the effect of avatrombopag on platelet counts in Japanese subjects. Subjects will be enrolled into 2 cohorts according to the mean platelet count measured at Screening and Baseline. Within the lower baseline platelet count cohort (less than 40 x 10\^9/L), subjects will be randomized in a 1:1:1:3 ratio to receive placebo, 20 mg avatrombopag, 40 mg avatrombopag, or 60 mg avatrombopag for 5 days. Within the higher baseline platelet count cohort (from 40 to less than 50 x 10\^9/L), subjects will be randomized in a 2:1:2 ratio to receive placebo, 20 mg avatrombopag, or 40 mg avatrombopag for 5 days.

Timeline

Start

2014-07

Primary completion

2015-04-01

Completion

2015-04-01

Publications

• Eguchi Y, Takahashi H, Mappa S, Santagostino E. Phase 2 study of avatrombopag in Japanese patients with chronic liver disease and thrombocytopenia. Hepatol Res. 2022 Apr;52(4):371-380. doi: 10.1111/hepr.13755. Epub 2022 Feb 21.

Drugs

Indications