An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

PHASE2CompletedINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

February 21, 2018

Primary Completion Date

May 12, 2020

Study Completion Date

May 12, 2020

Conditions
Graft-versus-host DiseaseAcute-graft-versus-host Disease
Interventions
DRUG

Defibrotide

6.25 mg/kg via 2-hour IV infusion every 6 hours

DRUG

Standard of Care

Administered according to local institutional guidelines, physician preference, and patient need.

Trial Locations (62)

1099

Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon

1200

Cliniques Universitaires Saint-Luc, Brussels

1756

Specialized Hospital for Active Treatment of Haematological Diseases - Sofia, Sofia

3000

UZ Leuven, Leuven

4020

Ordensklinikum Linz, Krankenhaus der Elisabethinen GmbH, Linz

6020

Universitätsklinikum Innsbruck, Innsbruck

9000

UZ Gent, Ghent

10000

Klinichki Bolnicki Centar Zagreb, Zagreb

10467

Montefiore Einstein Cancer Center, The Bronx

12462

Attikon University General Hospital, Athens

13125

Helios Klinikum Berlin Buch, Berlin

15006

Hospital Universitario Marques de Valdecilla, A Coruña

15236

Klinikum Frankfurt (Oder) GmbH, Brandenburg

17033

Penn State Milton S Hershey Medical Center, Hershey

20162

ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda, Milan

26500

University General Hospital of Patras, Pátrai

26506

West Virginia University Hospital, Morgantown

27514

University of North Carolina at Chapel Hill, Chapel Hill

28222

Hospital Universitario Puerta de Hierro - Majadahonda, Madrid

29425

MUSC-Hollings Cancer Center, Charleston

30322

Emory University Hospital, Atlanta

31059

Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse

32224

Mayo Clinic Jacksonville - PPDS, Jacksonville

32804

Blood & Marrow Transplant Center, Orlando

35010

Hospital de Gran Canaria Doctor Negrin, Las Palmas de Gran Canaria

37007

Complejo Asistencial Universitario de Salamanca - H. Clinico, Salamanca

37075

University Medicine Göttingen Germany, Göttingen

40202

James Graham Brown Cancer Center, Louisville

41013

Hospital Universitario Virgen del Rocio, Seville

Hospital Clinico Universitario de Valencia, Valencia

41236

Azienda Ospedaliero Universitaria di Parma, Parma

44892

Medizinische Universitätsklinik Knappschaftskrankenhaus, Bochum

50937

Uniklinik Köln, Cologne

59037

CHRU Lille, Lille

60611

Northwestern Memorial Hospital, Chicago

66205

University of Kansas Medical Center, Westwood

68167

Klinikum Mannheim Universitätsklinikum gGmbH, Mannheim

68198

University of Nebraska Medical Center, Omaha

70121

Ochsner Clinic Foundation, New Orleans

81675

Klinikum rechts der Isar der Technischen Universität München, München

90033

USC Norris Cancer Center, Los Angeles

90095

Mattel Children's Hospital UCLA, Los Angeles

92141

Hospital d Instructions des Armees Percy, Clamart

93053

Klinikum der Universitat Regensburg, Regensburg

94143

University of California, San Francisco Medical Center, San Francisco

94304

Stanford University, Palo Alto

94805

Institut Gustave Roussy, Villejuif

98108

VA Puget Sound Health Care System, Seattle

H1T 2M4

Hôpital Maisonneuve-Rosemont, Montreal

H3T 1C5

Sainte Justine Hospital, Montreal

H4A 3J1

McGill University Health Center, Montreal

01307

Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden

06120

Universitaetsklinikum Halle (Saale), Halle

04103

Universitatsklinikum Leipzig, Leipzig

00165

Ospedale Pediatrico Bambino Gesù, Roma

00-001

Centrum Onkologii im. Marii Sklodowskiej-Curie, Warsaw

53-439

Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku, Wroclaw

B9 5SS

Birmingham Heartlands Hospital, Birmingham

LS9 7TF

St James University Hospital, Leeds

St. James University Hospital, Leeds

LE1 5WW

Leicester Royal Infirmary, Leicester

Manchester Royal Infirmary, Manchester

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY