Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02)

PHASE3CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

February 16, 2012

Primary Completion Date

November 30, 2013

Study Completion Date

March 31, 2014

Conditions
Chronic ThrombocytopeniaImmune Thrombocytopenia
Interventions
DRUG

Avatrombopag

DRUG

Placebo

DRUG

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."

Trial Locations (25)

Unknown

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

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT01438840 - Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02) | Biotech Hunter | Biotech Hunter