CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
Blinded (placebo) +2 moredrug
Likely dose
Open Label (Avatrombopag tablets) 10 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/NCT00625443
NCT00625443Phase 2Completed
CompareCT.gov

A Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP) Who Completed 28 Days of Study Treatment in Protocol 501-CL-003

Eisai Inc.·interventional·Posted Feb 28, 2008·Updated Mar 16, 2018

In Brief

A Phase 2 clinical trial evaluating Blinded (placebo), Open Label (Avatrombopag tablets), and 1 other intervention for Idiopathic Thrombocytopenic Purpura. Completed, enrolled 53 participants across 12 sites.

Detailed Summary

The purpose of this study is to determine the safety and efficacy of AKR-501 (avatrombopag) administered in participants with chronic Idiopathic Thrombocytopenic Purpura (ITP) who were enrolled into and completed 28 days of study treatment in Protocol 501-CL-003 (NCT00441090).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Thrombocytopenic Purpura
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 28, 2008
Enrollment StartMay 1, 2007
Primary CompletionJun 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.3 years ago

Interventions

Blinded (placebo)drug

Placebo Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack) Duration - 6 months

Open Label (Avatrombopag tablets)drug

Dose 10 mg Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack) Duration - 6 months

Blinded (Avatrombopoag tablets)drug

Dose: 2.5, 5, 10, or 20 mg Orally, once daily administered under fasting conditions (at least 1 hr prior to or at least 2 hours after a meal or snack) Duration - 6 months