Eltrombopag for the Treatment of Thrombocytopenia Due to Low- and Intermediate Risk Myelodysplastic Syndromes

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

June 11, 2011

Primary Completion Date

February 2, 2017

Study Completion Date

October 31, 2026

Conditions
Myelodysplastic SyndromesThrombocytopenia
Interventions
DRUG

Eltrombopag/Revolade

Eltrombopag 50 mg once daily has been selected as the starting dose for this study. Thereafter, dependent on platelet response the dose of study medication can be increased by 50 mg every 2 weeks, up to a maximum dose of 300 mg once daily (150 mg in subjects of East Asian ethnicity).

OTHER

Placebo

The administration is the same of eltrombopag

Trial Locations (64)

89100

Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria

Unknown

CHU Amiens, Amiens

Centre d'Avignon, Avignon

Hôpital de la Côte Basque, Bayonne

Centre d'Avicenne, Hôpital d'Avicenne, Bobigny

CHU de Haut-Lévèque, Bordeaux

Centre Hospitalier de Boulogne Sur Mer, Boulogne-sur-Mer

CHU Clémenceau, Caen

Centre Henri Mondor, Créteil

CHU de Grenoble, Grenoble

Centre Le Mans, Le Mans

Hôpital Saint Vincent de Paul, Lille

CHRU de Limoges, Limoges

Centre de Marseille, Marseille

CHU Brabois, Nancy

Centre de Nantes, Nantes

Hopital Archet 1, Nice

Centre Hospitalier Universitaire de Nimes, Nîmes

Centre de St Louis, Hôpital St Louis, Paris

Centre Hospitalier de la Région d'Annecy, Pringy

Centre de Rouen, Centre Henri Becquerel, Rouen

CHU Purpan, Toulouse

CHU de Bretonneau, Tours

Heinrich-Heine-Universität Düsseldorf, Düsseldorf

Universitätsmedizin Mannheim, Mannheim

A.O. SS. Antonio e Biagio e Cesare Arrigo, Alessandria

Ospedale Riuniti, Ancona

Ospedale Cardinal Massaia, Asti

A.O. S. Giovanni Moscati, Avellino

Policlinico Università di Bari, Bari

Ospedale A. Perrino, Brindisi

"Ospedale Roberto Binaghi", Cagliari

Ospedale L'Annunziata, Cosenza

Ospedale Ferrarotto, Catania

Ospedale Garibaldi, Catania

Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

Azienda Ospedaliera Universitaria Careggi, Florence

Università degli Studi di Genova, Genova

Ospedale Vito Fazzi, Lecce

IRCCS Ospedale Maggiore Policlinico, Milan

Ospedale Niguarda, Milan

Ospedale Civile Spirito Santo, Pescara

Arcispedale di Santa Maria Nuova, Reggio Emilia

A.O. San Camillo Forlanini, Roma

Ospedale Sant'Eugenio, Roma

Policlinico Agostino Gemelli, Roma

Università Campus Bio Medico di Roma, Roma

Azienda Ospedaliera Sant'Andrea, Rome

IRCCS Istituto Regina Elena, Rome

Ospedale Nuova Regina Margherita, Rome

Policlinico Umberto I, Rome

Policlinico Universitario Tor Vergata, Rome

A.O.U. San Giovanni di Dio e Ruggì D'Aragona, Salerno

Policlinico Santa Maria alle Scotte, Siena

A.O. Santa Maria, Terni

A.O. Citta' della Salute e della Scienza di Torino, Torino

U.O. Citta' della Salute e della Scienza di Torino, Torino

General Hospital Celje, Celje

Univerzitetni klinini center Ljubljana, Ljubljana

University Medical Centre Maribor, Maribor

General Hospital Murska Sobota, Murska Sobota

General Hospital Nova Gorica, Nova Gorica

General Hospital Novo mesto, Novo Mesto

General Hospital Slovenj Gradec, Slovenj Gradec

All Listed Sponsors
lead

Associazione Qol-one

OTHER