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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

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial Description

Participants eligible to enroll into this rollover protocol will begin study treatment within 2-5 days of their Day 28 study termination visit in Protocol 501-CL-003 (NCT00441090). Participants who met the primary efficacy response criterion in Protocol 501-CL-003 will continue receiving the same study treatment to which they were assigned in the previous protocol in a double-blinded manner, these being one of the following 5 treatments:

- avatrombopag 2.5 mg daily

- avatrombopag 5 mg daily

- avatrombopag 10 mg daily

- avatrombopag 20 mg daily

- placebo

Participants who did not meet the primary efficacy response criterion in Protocol 501-CL-003 who otherwise meet the eligibility criteria for this rollover protocol will be offered open label avatrombopag 10 mg daily.

This is a parallel group, rollover study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00625443
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 2
Start date May 2007
Completion date October 2009
View Details
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