Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00628498

Public ClinicalTrials.gov record NCT00628498. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 11:19 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.

Study identification

NCT ID
NCT00628498
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Jazz Pharmaceuticals
Industry
Enrollment
1,206 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2007 (Type not available)
Primary completion
Jul 2016 (Actual)
Completion
Sep 2016 (Actual)
Last update posted
Nov 30, 2017

2007 – 2016

United States locations

U.S. sites
125
U.S. states
41
U.S. cities
90
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233 —
Phoenix Children's Hospital Phoenix Arizona 85016 —
Mayo Clinic Cancer Center Phoenix Arizona 85054 —
Arizona Oncology Scottsdale Arizona 85258 —
University Medical Center Tucson Arizona 85724 —
University of Arkansas for Medical Services Little Rock Arkansas 72205 —
City of Hope Medical Center Duarte California 91010 —
The University of California, San Diego La Jolla California 92037 —
Loma Linda University Loma Linda California 92354 —
Long Beach Memorial Medical Center Long Beach California 90806 —
Children's Hospital of Los Angeles Los Angeles California 90027 —
Children's Hospital & Research Center Oakland Oakland California 94609 —
Children's Hospital of Orange County (CHOC) Orange California 92868 —
Sutter Institute for Medical Research Sacramento California 95816 —
University of California Davis Health System Sacramento California 95817 —
Rady's Children's Hospital - San Diego San Diego California 92123 —
University of California San Francisco Medical Center San Francisco California 94143 —
Stanford University Medical Center Stanford California 94305 —
Children's Hospital Colorado Aurora Colorado 80045 —
US Oncology - Denver Denver Colorado 80218 —
Yale - New Haven Hospital New Haven Connecticut 06520 —
Nemours-Al duPont Hospital for Children Wilmington Delaware 19803 —
Georgetown University Hospital Washington D.C. District of Columbia 20007 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
UF Health Shands Hospital Gainesville Florida 32610 —
Jackson Memorial- University of Miami Health System- Pediatrics Miami Florida 33136 —
Nicklaus Children's Hospital (Miami Children's Hospital) Miami Florida 33155 —
Florida Hospital Orlando Florida 42803 —
All Children's Hospital Specialty Physicians St. Petersburg Florida 33701 —
H. Lee Moffitt Cancer Center & Research Institute Tampa Florida 33612 —
Childrens Healthcare of Atlanta Atlanta Georgia 30322 —
Emory University Hospital Atlanta Georgia 30322 —
Northside Hospital Atlanta Georgia 30342 —
Kapi'olani Medical Center for Women and Children Honolulu Hawaii 96826 —
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
Northwest Memorial Hospital Chicago Illinois 60611 —
Rush University Medical Center Chicago Illinois 60612 —
Pediatric Hematology/Oncology MC4060 - University of Chicago Chicago Illinois 60637 —
Cardinal Bernardin Cancer-Loyola University Medical Center Maywood Illinois 60153 —
Riley Hospital for Children Indianapolis Indiana 46202 —
Indiana Blood and Marrow Transplantation Clinical Lab LLC/St. Francis Hospital Indianapolis Indiana 46237 —
University of Iowa Hospitals & Clinics Iowa City Iowa 52242 —
University of Kansas Cancer Center Kansas City Kansas 66160 —
Pediatric Blood and Cancer Disorders Clinic Louisville Kentucky 40202 —
University of Louisville Research Foundation Louisville Kentucky 40202 —
Tulane University Hospital & Clinic (Tuhc) - Tulane Cancer Center Comprehensive Clinic (Tcccc) New Orleans Louisiana 70112 —
Children's Hospital New Orleans Louisiana 70118 —
University of Maryland - Greenebaum Cancer Center Baltimore Maryland 21201 —
Johns Hopkins University Baltimore Maryland 21287 —
National Institutes of Health Bethesda Maryland 20892 —
Tufts Medical Center Boston Massachusetts 02111 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Boston Children's Hospital DFCI/CHB-Pediatrics Boston Massachusetts 02115 —
Dana-Farber Cancer Institute Boston Massachusetts 02115 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
University of Michigan Health System Ann Arbor Michigan 48109 —
Wayne State University/Children's Hospital of Michigan Detroit Michigan 48201 —
Henry Ford Hospital Detroit Michigan 48202 —
Helen DeVos Children's Hospital - Spectrum Health Grand Rapids Michigan 49503 —
Children's Hospitals and Clinics of Minnesota and Minneapolis Minneapolis Minnesota 55404 —
University of Minnesota Medical Center Minneapolis Minnesota 55455 —
Mayo Clinic Rochester Minnesota 55905 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Children's Mercy Hospital and Clinics - Infectious Diseases Kansas City Missouri 64108 —
Cardinal Glennon Children's Medical Center/St. Louis University Department of Pediatrics St Louis Missouri 63104 —
Washington University/St. Louis Children's Hospital St Louis Missouri 63110 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Hackensack University Medical Center - Joseph M. Sanzari Childrens Hospital Hackensack New Jersey 07601 —
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey 08903 —
Presbyterian Hospital Albuquerque New Mexico 87106 —
Roswell Park Cancer Institute Buffalo New York 14263 —
Steven and Alexandra Cohen Children's Medical Center New Hyde Park New York 11040 —
New York University School of Medicine New York New York 10016 —
Memorial Sloan Kettering Cancer Center New York New York 10021 —
Mount Sinai Hospital - BMT Program New York New York 10029 —
Mount Sinai Medical Center New York New York 10029 —
Morgan Stanley Children's Hospital - Columbia University Medical Center New York New York 10032 —
Weill Cornell Medical College - New York Presbyterian Hospital New York New York 10065 —
University of Rochester Medical Center, Strong Memorial Hospital Rochester New York 14642 —
Stony Brook University Hospital Stony Brook New York 11794 —
Montefiore Medical Center The Bronx New York 10467 —
New York Medical College Valhalla New York 10595 —
The University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599 —
Levine Children's Hospital Charlotte North Carolina 28203 —
Duke University Medical Center Durham North Carolina 27710 —
Wake Forest Baptist Health Winston-Salem North Carolina 27157 —
Children's Hospital Medical Akron Ohio 44308 —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229 —
The Jewish Hospital Cincinnati Ohio 45236 —
Case Western Reserve University (Cwru) - University Hospitals of Cleveland (Uhc) Cleveland Ohio 44106 —
Robert J Tomsich Pathology & Laboratory Medicine Institute Cleveland Ohio 44195 —
Nationwide Children's Hospital - Ohio State University College of Medicine (OSUCOM) Columbus Ohio 43205 —
The Ohio State University, James Cancer Hospital Columbus Ohio 43210 —
The University of Oklahoma Health Science Center Oklahoma City Oklahoma 73104 —
Doernbecher Children's Hospital - Oregon Health and Science University Portland Oregon 97239 —
Oregon Health and Science University Portland Oregon 97239 —
Geisinger Medical Center Danville Pennsylvania 17822 —
Milton S. Hershey Medical Center Hershey Pennsylvania 17033 —
The Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15219 —
West Penn Allegheny Health System Pittsburgh Pennsylvania 15224 —
Medical University of South Carolina Charleston South Carolina 29425 —
Greenville Health System Cancer Institute Greenville South Carolina 29605 —
Avera Cancer Institute Sioux Falls South Dakota 57105 —
Methodist University Hospital Memphis Tennessee 38104 —
St. Jude Children's Research Hospital - Department of Bone Marrow Transplantation and Cellular Therapy Memphis Tennessee 38105 —
The Children's Hospital at TriStar Centennial Nashville Tennessee 37203 —
Vanderbilt Ingram Cancer Center Nashville Tennessee 37232 —
Children's Medical Center of Dallas Dallas Texas 75235 —
San Antonio Military Medical Center Fort Sam Houston Texas 78234 —
Cook Children's Health Care Hospital Fort Worth Texas 76104 —
Baylor College of Medicine Houston Texas 77030 —
Texas Children's Hospital Houston Texas 77030 —
The University of Texas - MD Anderson Cancer Center Houston Texas 77030 —
University of Texas MD Anderson Cancer Center Houston Texas 77030 —
Methodist Healthcare System of San Antonio San Antonio Texas 78229 —
University of Utah Salt Lake City Utah 84132 —
University of Virginia Health System Charlottesville Virginia 22908 —
Children's Hospital of the King's Daughter Norfolk Virginia 23507 —
Virginia Commonwealth University Richmond Virginia 23298 —
Fred Hutchinson Cancer Research Center/Seattle Children Hospital Seattle Washington 98109 —
Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington 99204 —
Mary Babb Randolph Cancer Center - West Virginia University Hospital Morgantown West Virginia 26505 —
University of Wisconsin, American Family Children's Hospital, Medical School Madison Wisconsin 53792 —
Medical College of Wisconsin/ Children's Hospitalof Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00628498, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 30, 2017 · Synced Oct 30, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00628498 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →