Clinical Trial: A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Ad
Brief Summary:
Core study:
To compare the efficacy of avatrombopag (in addition to standard) of care to eltrombopag (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia (idiopathic thrombocytopenic purpura [ITP]) as measured by durable platelet response.
Open-label Extension Phase:
To evaluate the safety and tolerability of long-term therapy with avatrombopag in participants with chronic ITP (cITP).
Detailed Summary: The study consisted of three phases: Prerandomization, Randomization (Core Study) and Extension Phase. Participants 18 years of age and over, who meet all the eligibility requirements, were randomized into the study. It was required that splenectomized participants made up at least 35% of the study population and no single platelet count was greater than 35x10^9/L. Participants were centrally stratified at randomization by splenectomy status, baseline platelet count, and use of concomitant ITP medication at baseline and were randomized to receive either double-blind avatrombopag or eltrombopag in a 1:1 ratio. Participants received blinded therapy at a starting dose of 20 mg avatrombopag once daily or 50 mg eltrombopag once daily. Participants were allowed to have their dose titrated up (maximum dose 40 mg avatrombopag and 75 mg for eltrombopag) or down (minimum dose 5 mg for avatrombopag and 25 mg for eltrombopag) depending on their response to study drug. The goal of dose modification was to maintain the platelet count at levels greater than or equal to 50x10^9/L and less than or equal to 150x10^9/L, and to decrease the need for ITP-directed concomitant medications. The duration of treatment in the Core study and the Extension Phase is approximately 26 and 104 weeks, respectively.
Sponsor: Eisai Inc.
Current Primary Outcome: Durable platelet response as defined by the proportion of subjects who have at least 6 of 8 weekly platelet responses during the last 8 weeks of treatment over the 6-month treatment period in absence of rescue therapy [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Eisai Inc.
Dates:
Date Received: September 13, 2011
Date Started: April 2012
Date Completion:
Last Updated: March 10, 2016
Last Verified: February 2016
