An Efficacy Study for Epoetin Alfa in Anemic Patients With Myelodysplastic Syndromes

PHASE3CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

January 31, 2015

Study Completion Date

January 31, 2016

Conditions
Myelodysplastic Syndromes
Interventions
DRUG

Group 2: Placebo

form= solution for injection, route= subcutaneous use, weekly injections for 24 to 48 weeks

DRUG

Group 1: Epoetin alfa

type = range, unit= IU/Kg, number= 337.5 to 1050 IU/Kg, form= solution for injection, route= subcutaneous use, weekly injections (max 40,000 IU per week for first 8 weeks of treatment, max 80,000 IU per week later) using pre-filled 1mL 40,000 IU syringes for 24 to 48 weeks

Trial Locations (28)

Unknown

Plovdiv

Sofia

Varna

Amiens

Angers

Bobigny

Colmar

Paris

Pessac

Pierre-Bénite

Saint-Priest-en-Jarez

Tours

Vandœuvre-lès-Nancy

Berlin

Dresden

Duisburg

Düsseldorf

Dÿsseldorf

München

Oldenburg

Würzburg

Athens

Goudi-Athens

Larissa

Pátrai

Thessalonikis

Saint Petersburg

Yekaterinburg

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY