CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 204 enrolled
Drug / intervention
avatrombopag (lower baseline platelet count) +3 moredrug
Likely dose
avatrombopag (lower baseline platelet count) 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01976104
NCT01976104Phase 3Completed
CompareCT.gov

A Randomized, Global, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Once-daily Oral Avatrombopag for the Treatment of Adults With Thrombocytopenia Associated With Liver Disease Prior to an Elective Procedure

Eisai Inc.·interventional·Posted Nov 5, 2013·Updated Feb 27, 2018

In Brief

A Phase 3 clinical trial evaluating avatrombopag (lower baseline platelet count), placebo (lower baseline platelet count), and 2 other interventions for Thrombocytopenia Associated With Liver Disease. Completed, enrolled 204 participants across 120 sites in 17 countries.

Detailed Summary

This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombocytopenia Associated With Liver Disease
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Israel, Italy, Japan, Mexico, Romania, Russia, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 5, 2013
Enrollment StartNov 1, 2013
Primary CompletionJan 30, 2017
Study CompletionFeb 21, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.7 years ago

Interventions

avatrombopag (lower baseline platelet count)drug

60 mg avatrombopag (3 x 20 mg tablets)

placebo (lower baseline platelet count)drug

60 mg placebo (3 x 20 mg matching placebo tablets)

avatrombopag (higher baseline platelet count)drug

40 mg avatrombopag (2 x 20 mg tablets)

placebo (higher baseline platelet count)drug

40 mg placebo (2 x 20 mg matching placebo tablets)