CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
Avatrombopag +2 moredrug
Likely dose
Avatrombopag 80 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/NCT00914927
NCT00914927Phase 2Completed

A Phase 2, Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics of Once-Daily Oral E5501 Tablets Used Up to 7 Days in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures

Eisai Inc.·interventional·Posted Jun 5, 2009·Updated Jan 23, 2018

In Brief

A Phase 2 clinical trial evaluating Avatrombopag and Placebo for Thrombocytopenia Related to Chronic Liver Disease. Completed, enrolled 130 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy of once-daily Oral avatrombopagin subjects with chronic liver diseases and thrombocytopenia prior to elective surgical or diagnostic procedures, to evaluate the safety of short-term administration of avatrombopag and to evaluate the pharmacokinetics (PK) of E5501.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 5, 2009
Enrollment StartMay 1, 2009
Primary CompletionNov 11, 2011
Study CompletionDec 21, 2011
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 17.1 years ago

Interventions

Avatrombopagdrug

Avatrombopag first Dose 80 mg followed by 10 mg a day for up to 6 additional days

Avatrombopagdrug

Avatrombopag first Dose 80 mg followed by 20 mg a day for 3 days and then Placebo for 3 additional days

Placebodrug

Placebo or inactive substance once a day for up to 7 days