Defibrotide

Generic Name
Defibrotide
Brand Names
Defitelio
Drug Type
Biotech
Chemical Formula
-
CAS Number
83712-60-1
Unique Ingredient Identifier
568FY5I1YI
Background

Defibrotide is the sodium salt of a mixture of single-stranded oligodeoxyribonucleotides derived from porcine mucosal DNA. It has been shown to have antithrombotic, anti-inflammatory and anti-ischemic properties (but without associated significant systemic anticoagulant effects). It is marketed under the brand names Dasovas (FM), Noravid, and Prociclide in a...

Indication

Indicated for the treatment of severe hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT).

Associated Conditions
Sinusoidal Obstruction Syndrome (SOS)
Associated Therapies
-

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

First Posted Date
2017-11-13
Last Posted Date
2021-08-18
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
152
Registration Number
NCT03339297
Locations
🇦🇹

Universitätsklinikum Innsbruck, Innsbruck, Austria

🇭🇷

Klinichki Bolnicki Centar Zagreb, Zagreb, Croatia

🇩🇪

Uniklinik Köln, Köln, Germany

and more 59 locations

Defibrotide in the Human Endotoxemia Model --- an Exploratory Trial Investigating the Effects and the Mechanisms of Defibrotide

First Posted Date
2016-08-24
Last Posted Date
2019-12-19
Lead Sponsor
Bernd Jilma
Target Recruit Count
20
Registration Number
NCT02876601
Locations
🇦🇹

Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria

Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients

First Posted Date
2016-08-01
Last Posted Date
2022-03-02
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
372
Registration Number
NCT02851407
Locations
🇯🇵

Osaka City University Hospital, Osaka, Japan

🇯🇵

Medical Hospital Tokyo Medical and Dental University, Tokyo, Japan

🇰🇷

Severance Hospital at Yonsei University Health System, Seoul, Korea, Republic of

and more 111 locations

Myeloablative Conditioning, Prophylactic Defibrotide and Haplo AlloSCT for Patients With Sickle Cell Disease

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2016-02-05
Last Posted Date
2024-07-31
Lead Sponsor
New York Medical College
Target Recruit Count
40
Registration Number
NCT02675959
Locations
🇺🇸

New York Medical College, Valhalla, New York, United States

🇺🇸

University of California Los Angeles, Los Angeles, California, United States

🇺🇸

University of Florida, Gainesville, Florida, United States

and more 1 locations

Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-03-05
Last Posted Date
2017-11-30
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
1206
Registration Number
NCT00628498
Locations
🇺🇸

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

University of Maryland - Greenebaum Cancer Center, Baltimore, Maryland, United States

🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

and more 122 locations

Melphalan, Prednisone, Thalidomide and Defibrotide in Relapsed Multiple Myeloma Patients

First Posted Date
2006-12-04
Last Posted Date
2016-05-10
Lead Sponsor
Silvio Aime
Target Recruit Count
24
Registration Number
NCT00406978
Locations
🇮🇹

Div. Univ. Di Ematologia, Az. Osp. San Giovanni Battista, Torino, TO, Italy

🇮🇹

Dip. Scienze Mediche & IRCAD-Università, UDA Ematologia, Novara, Italy

🇮🇹

Servizio di Ematologia, Azienda Ospedaliera S. Maria Nuova, Reggio Emilia, Italy

and more 2 locations

Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-08-01
Last Posted Date
2017-01-30
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
134
Registration Number
NCT00358501

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

Phase 2
Completed
Conditions
Interventions
First Posted Date
2006-01-09
Last Posted Date
2011-06-09
Lead Sponsor
European Society for Blood and Marrow Transplantation
Target Recruit Count
360
Registration Number
NCT00272948
Locations
🇩🇪

Klinik Kinder-Onkologie, Düsseldorf, Germany

🇬🇧

Children's Hospital, Manchester, United Kingdom

🇮🇹

Institute G. Gaslini, Genova, Italy

and more 20 locations

Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver

Conditions
First Posted Date
2005-12-12
Last Posted Date
2014-07-01
Lead Sponsor
Emory University
Registration Number
NCT00263978
Locations
🇺🇸

Children's Healthcare of Atlanta, Atlanta, Georgia, United States

Compassionate Use of Defibrotide for Patients With Veno-occlusive Disease of the Liver

First Posted Date
2005-09-02
Last Posted Date
2017-04-25
Lead Sponsor
St. Jude Children's Research Hospital
Registration Number
NCT00143546
Locations
🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

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