Pediatric Trial Investigating the Incidence & Outcome of Veno-Occlusive Disease With the Prophylactic Use of Defibrotide

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

January 31, 2009

Study Completion Date

July 31, 2009

Conditions
Hepatic Veno-Occlusive Disease
Interventions
DRUG

Defibrotide

Defibrotide 25 mg/kg/d

DRUG

Defibrotide

Defibrotide 25 mg/kg/d iv in 4 doses beginning at day of conditioning until day +30 or until discharge from inpatient care (with a minimum treatment of 14 days) if VOD does not occur.

DRUG

Defibrotide

Defibrotide 25 mg/kg/d iv therapeutically when patients fulfil modified Seattle criteria

Trial Locations (30)

Unknown

University Hospital, Graz

St Anna Kinderspital, Vienna

Inst. Gustave Roussy, Villejuif

University Hospital, Dresden

Klinik Kinder-Onkologie, Düsseldorf

Johann-Wolfgang Goethe Universität, Frankfurt

Universitätsspital Eppendorf, Hamburg

Medical School, Hanover

University Hospital, Heidelberg

Kinderklinik, Jena

Christian-Albrecht -University, Kiel

Kinderpoliklinik Uni, München

Poliklinik Kinderheilkunde, Münster

Universitätsspital, Tübingen

Our Lady's Hospital for Sick Children, Dublin

Schneider Children's MC, Petah Tikva

Institute G. Gaslini, Genova

Ospedale S. Gerardo, Monza

Clinica di Oncoematologia Pediatrica, Padua

University Hospital, Utrecht

Sahlgrenska University Hospital, Gothenburg

University Hospital, Huddinge

University Hospital, Lund

University Hospital, Uppsala

University Children Hospital, Basel

Inselspital, Bern

Hopital Cantonal Universitaire, Geneva

University Hospital, Zurich

Great Ormond Street Hospital, London

Children's Hospital, Manchester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Jazz Pharmaceuticals

INDUSTRY

collaborator

Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

lead

European Society for Blood and Marrow Transplantation

NETWORK