Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003

Phase 2 Completed 53 enrolled Eisai Inc.

Non-randomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start: 2007-05
Primary completion: 2009-06
Completion: 2009-10

Publications

Bussel JB, Kuter DJ, Aledort LM, Kessler CM, Cuker A, Pendergrass KB, Tang S, McIntosh J. A randomized trial of avatrombopag, an investigational thrombopoietin-receptor agonist, in persistent and chronic immune thrombocytopenia. Blood. 2014 Jun 19;123(25):3887-94. doi: 10.1182/blood-2013-07-514398. Epub 2014 May 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avatrombopag	Small molecule	2.5 mg	Oral
Subject	Avatrombopag	Small molecule	5 mg	Oral
Subject	Avatrombopag	Small molecule	10 mg	Oral
Subject	Avatrombopag	Small molecule	20 mg	Oral

Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003

Summary

Timeline

Publications

Drugs

Indications