Purpura, Thrombocytopenic, Idiopathic Clinical Trial
Official title:
A Phase 2 Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled, Parallel Group Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP).
The purpose of this study is to determine the efficacy, safety and tolerability, of AKR-501 (avatrombopag) tablets, as compared to placebo, in the treatment of participants with chronic Idiopathic Thrombocytopenic Purpura (ITP).
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging,
parallel-group study. The pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD)
relationship of avatrombopag will also be studied. Approximately 65 eligible participants
will be randomized in a 3:3:3:3:1 ratio in a double-blinded fashion into one of five parallel
treatment groups to receive daily doses of either avatrombopag 2.5, 5, 10 or 20 mg or placebo
for 28 days, respectively. Each avatrombopag dosing group will consist of 15 participants
while the placebo group will consist of 5 participants. All study participants will be
evaluated weekly (Days 3, 5, 7, 14, 21 and 28) for safety, efficacy, and (Days 7, 14, 21, and
28) avatrombopag PK while receiving study treatment with a final assessment for safety and
effectiveness to be done 2 weeks after the last study dose (Day 42).
At the completion of Visit Day 28±1, participants who complete 28±1 days of study dosing will
be assessed for eligibility to enroll into the rollover Study 501-CL-004 (NCT00625443) based
on this visit.
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