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
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).
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.
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