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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,206

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

July 31, 2016

Study Completion Date

September 30, 2016

Conditions
Hepatic Veno-Occlusive Disease
Interventions
DRUG

Defibrotide

"Defibrotide is a single-stranded polydeoxyribonucleotide derived from porcine intestinal mucosa by controlled depolymerisation. Defibrotide has a complex mechanism of action with antithrombotic, anti-ischemic, anti-inflammatory, anti-adhesive and thrombolytic properties but no significant systemic anti-coagulant effects.~Defibrotide is dose intravenously as a 2-hour infusion every 6 hours at a dose of 25 mg/kg/day. Recommended duration of therapy is 21 days."

DRUG

Defibrotide

Trial Locations (125)

10016

New York University School of Medicine, New York

10021

Memorial Sloan Kettering Cancer Center, New York

10029

Mount Sinai Hospital - BMT Program, New York

Mount Sinai Medical Center, New York

10032

Morgan Stanley Children's Hospital - Columbia University Medical Center, New York

10065

Weill Cornell Medical College - New York Presbyterian Hospital, New York

10467

Montefiore Medical Center, The Bronx

10595

New York Medical College, Valhalla

11040

Steven and Alexandra Cohen Children's Medical Center, New Hyde Park

11794

Stony Brook University Hospital, Stony Brook

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester Medical Center, Strong Memorial Hospital, Rochester

15219

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

15224

West Penn Allegheny Health System, Pittsburgh

17033

Milton S. Hershey Medical Center, Hershey

17822

Geisinger Medical Center, Danville

19104

The Children's Hospital of Philadelphia, Philadelphia

19803

Nemours-Al duPont Hospital for Children, Wilmington

20007

Georgetown University Hospital, Washington D.C.

20010

Children's National Medical Center, Washington D.C.

20892

National Institutes of Health, Bethesda

21201

University of Maryland - Greenebaum Cancer Center, Baltimore

21287

Johns Hopkins University, Baltimore

22908

University of Virginia Health System, Charlottesville

23298

Virginia Commonwealth University, Richmond

23507

Children's Hospital of the King's Daughter, Norfolk

26505

Mary Babb Randolph Cancer Center - West Virginia University Hospital, Morgantown

27157

Wake Forest Baptist Health, Winston-Salem

27599

The University of North Carolina at Chapel Hill, Chapel Hill

27710

Duke University Medical Center, Durham

28203

Levine Children's Hospital, Charlotte

29425

Medical University of South Carolina, Charleston

29605

Greenville Health System Cancer Institute, Greenville

30322

Childrens Healthcare of Atlanta, Atlanta

Emory University Hospital, Atlanta

30342

Northside Hospital, Atlanta

32610

UF Health Shands Hospital, Gainesville

33136

Jackson Memorial- University of Miami Health System- Pediatrics, Miami

33155

Nicklaus Children's Hospital (Miami Children's Hospital), Miami

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

33701

All Children's Hospital Specialty Physicians, St. Petersburg

35233

Children's Hospital of Alabama, Birmingham

37203

The Children's Hospital at TriStar Centennial, Nashville

37232

Vanderbilt Ingram Cancer Center, Nashville

38104

Methodist University Hospital, Memphis

38105

St. Jude Children's Research Hospital - Department of Bone Marrow Transplantation and Cellular Therapy, Memphis

39216

University of Mississippi Medical Center, Jackson

40202

Pediatric Blood and Cancer Disorders Clinic, Louisville

University of Louisville Research Foundation, Louisville

42803

Florida Hospital, Orlando

43205

Nationwide Children's Hospital - Ohio State University College of Medicine (OSUCOM), Columbus

43210

The Ohio State University, James Cancer Hospital, Columbus

44106

Case Western Reserve University (Cwru) - University Hospitals of Cleveland (Uhc), Cleveland

44195

Robert J Tomsich Pathology & Laboratory Medicine Institute, Cleveland

44308

Children's Hospital Medical, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45236

The Jewish Hospital, Cincinnati

46202

Riley Hospital for Children, Indianapolis

46237

Indiana Blood and Marrow Transplantation Clinical Lab LLC/St. Francis Hospital, Indianapolis

48109

University of Michigan Health System, Ann Arbor

48201

Wayne State University/Children's Hospital of Michigan, Detroit

48202

Henry Ford Hospital, Detroit

49503

Helen DeVos Children's Hospital - Spectrum Health, Grand Rapids

52242

University of Iowa Hospitals & Clinics, Iowa City

53226

Medical College of Wisconsin/ Children's Hospitalof Wisconsin, Milwaukee

53792

University of Wisconsin, American Family Children's Hospital, Medical School, Madison

55404

Children's Hospitals and Clinics of Minnesota and Minneapolis, Minneapolis

55455

University of Minnesota Medical Center, Minneapolis

55905

Mayo Clinic, Rochester

57105

Avera Cancer Institute, Sioux Falls

60153

Cardinal Bernardin Cancer-Loyola University Medical Center, Maywood

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

Northwest Memorial Hospital, Chicago

60612

Rush University Medical Center, Chicago

60637

Pediatric Hematology/Oncology MC4060 - University of Chicago, Chicago

63104

Cardinal Glennon Children's Medical Center/St. Louis University Department of Pediatrics, St Louis

63110

Washington University/St. Louis Children's Hospital, St Louis

64108

Children's Mercy Hospital and Clinics - Infectious Diseases, Kansas City

66160

University of Kansas Cancer Center, Kansas City

68198

University of Nebraska Medical Center, Omaha

70112

Tulane University Hospital & Clinic (Tuhc) - Tulane Cancer Center Comprehensive Clinic (Tcccc), New Orleans

70118

Children's Hospital, New Orleans

72205

University of Arkansas for Medical Services, Little Rock

73104

The University of Oklahoma Health Science Center, Oklahoma City

75235

Children's Medical Center of Dallas, Dallas

76104

Cook Children's Health Care Hospital, Fort Worth

77030

Baylor College of Medicine, Houston

Texas Children's Hospital, Houston

The University of Texas - MD Anderson Cancer Center, Houston

University of Texas MD Anderson Cancer Center, Houston

78229

Methodist Healthcare System of San Antonio, San Antonio

78234

San Antonio Military Medical Center, Fort Sam Houston

80045

Children's Hospital Colorado, Aurora

80218

US Oncology - Denver, Denver

84132

University of Utah, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

85054

Mayo Clinic Cancer Center, Phoenix

85258

Arizona Oncology, Scottsdale

85724

University Medical Center, Tucson

87106

Presbyterian Hospital, Albuquerque

90027

Children's Hospital of Los Angeles, Los Angeles

90806

Long Beach Memorial Medical Center, Long Beach

91010

City of Hope Medical Center, Duarte

92037

The University of California, San Diego, La Jolla

92123

Rady's Children's Hospital - San Diego, San Diego

92354

Loma Linda University, Loma Linda

92868

Children's Hospital of Orange County (CHOC), Orange

94143

University of California San Francisco Medical Center, San Francisco

94305

Stanford University Medical Center, Stanford

94609

Children's Hospital & Research Center Oakland, Oakland

95816

Sutter Institute for Medical Research, Sacramento

95817

University of California Davis Health System, Sacramento

96826

Kapi'olani Medical Center for Women and Children, Honolulu

97239

Doernbecher Children's Hospital - Oregon Health and Science University, Portland

Oregon Health and Science University, Portland

98109

Fred Hutchinson Cancer Research Center/Seattle Children Hospital, Seattle

99204

Providence Sacred Heart Medical Center and Children's Hospital, Spokane

06520

Yale - New Haven Hospital, New Haven

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02115

Boston Children's Hospital DFCI/CHB-Pediatrics, Boston

Dana-Farber Cancer Institute, Boston

02215

Beth Israel Deaconess Medical Center, Boston

07601

Hackensack University Medical Center - Joseph M. Sanzari Childrens Hospital, Hackensack

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY