49
Participants
Start Date
February 16, 2012
Primary Completion Date
November 30, 2013
Study Completion Date
March 31, 2014
Avatrombopag
Placebo
Standard of care
"Permitted ITP concomitant background therapies are as follows:~* Corticosteroids and/or azathioprine taken at a stable dose for 4 weeks before randomization;~* Mycophenolate mofetil (MMF) or danazol taken at a stable dose for at least 12 weeks before randomization;~* Cyclosporine A (CsA) (due to the fact that it is a P-glycoprotein-mediated transport \[P-gp\] inhibitor) is to be avoided unless deemed medically necessary; CsA taken at a stable dose for at least 12 weeks before randomization.~At the discretion of the investigator, participants will be allowed to use aspirin, other salicylates, or approved adenosine diphosphate (ADP) receptor antagonists, (eg, clopidogrel, prasugrel) during the study once their platelet count had risen.~Participants treated with proton pump inhibitors (PPIs) and H2 antagonist therapy will receive a stable dose for at least 6 weeks prior to randomization. Treatment with these therapies must have been completed at least 2 weeks prior to randomization."
Adelaide
Bedford Park
Antwerp
Plovdiv
Sofia
Brno
Hradec Králové
Prague
Rotterdam
Christchurch
Palmerston North
Bialystok
Chorzów
Gdansk
Krakow
Lodz
Wroclaw
Singapore
Bratislava
Johannesburg
Dnipropetrovsk
Donetsk
Ivano-Frankivsk
Kyiv
Lviv
Eisai Inc.
INDUSTRY