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Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study (Under CFR 312.34)


Phase 3
N/A
N/A
Open (Enrolling)
Both
Hepatic Veno-Occlusive Disease

Thank you

Trial Information

Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study (Under CFR 312.34)


Inclusion Criteria:



Entry criteria include the following:

1. Clinical diagnosis of VOD, made by Baltimore Criteria, Modified Seattle Criteria, or
biopsy proven:

1.1 Baltimore Criteria- Bilirubin ≥2 mg/dL and at least 2 of the following clinical
findings:

- Ascites (radiographic or physical exam)

- Weight gain of ≥5% compared to the day of conditioning-- if this value is not
available, the weight on the date of admission to the SCT unit may be used)

- Hepatomegaly; increased over baseline.

1.2 Modified Seattle Criteria: At least two of the following

- Bilirubin ≥2 mg/dL

- Ascites (radiographic or physical exam) and/or weight gain ≥5% above baseline
weight (defined as weight on the first day of conditioning- if this value is not
available, the weight on the date of admission to the SCT unit may be used)

- hepatomegaly increased over baseline

1.3 Patients that do not meet the Baltimore Criteria or Modified Seattle Criteria
and have biopsy proven VOD are eligible.

2. Patient must also provide written informed consent.

Exclusion Criteria:

- Use of any medication which increases the risk of hemorrhage is disallowed. Use of
heparin or other anticoagulants is disallowed within 12 hours unless being used for
routine central venous line management, fibrinolytic instillation for central venous
line occlusion, intermittent dialysis or ultrafiltration of CVVH.

- Clinically significant uncontrolled acute bleeding, defined as hemorrhage requiring >
15 cc/kg of packed red blood cells (e.g., a pediatric patient weighing 20 kg and
requiring > 300cc of packed red blood cells/24 hours, or an adult patient weighing 70
kg and requiring >3 units of packed red blood cells/24 hours) to replace blood loss,
OR bleeding from a site which in the Investigator's opinion constitutes a potential
life-threatening source (e.g. pulmonary hemorrhage or CNS bleeding), irrespective of
amount of blood loss, at any point from the date of SCT through the date of severe
VOD diagnosis.

- Hemodynamic instability as defined by a requirement for multiple pressors, or
inability to maintain mean arterial pressure (for children: to maintain mean arterial
pressure within 1 standard deviation of age-adjusted levels) with single pressor
support.

- Woman who are pregnant.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response of VOD

Outcome Time Frame:

D+100 from SCT or 100 days from start of chemotherapy

Safety Issue:

No

Principal Investigator

Carin Heringa, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gentium, S.p.A.

Authority:

United States: Food and Drug Administration

Study ID:

P2006-05

NCT ID:

NCT00628498

Start Date:

December 2007

Completion Date:

Related Keywords:

  • Hepatic Veno-Occlusive Disease
  • VOD
  • Hepatic Veno-Occlusive Disease
  • Budd-Chiari Syndrome

Name

Location

Johns Hopkins University Baltimore, Maryland  21205
Memorial Sloan Kettering Cancer Center New York, New York  10021
Cleveland Clinic Foundation Cleveland, Ohio  44195
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Medical University of South Carolina Charleston, South Carolina  29425-0721
University of California Davis Medical Center Sacramento, California  95817
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
University Hospitals of Cleveland Cleveland, Ohio  44106
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Rochester Medical Center Rochester, New York  14642
Hackensack University Medical Center Hackensack, New Jersey  07601
Long Beach Memorial Medical Center Long Beach, California  90806
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Miami Children's Hospital Miami, Florida  33155-4069
All Children's Hospital St. Petersburg, Florida  33701
Carolinas Medical Center Charlotte, North Carolina  28232-2861
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Texas Children's Cancer Center Houston, Texas  77030-2399
West Virginia University Hospitals Morgantown, West Virginia  26506-9300
Phoenix Children's Hospital Phoenix, Arizona  85016-7710
Yale Cancer Center New Haven, Connecticut  06520-8028
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Rady Children's Hospital - San Diego San Diego, California  92123-4282
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
Akron Children's Hospital Akron, Ohio  44308-1062
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15213
Massachusetts General Hospital Boston, Massachusetts  02114-2617
City of Hope Duarte, California  91010
Children's Medical Center of Dallas Dallas, Texas  75235
Children's Hospital of Alabama Birmingham, Alabama  35233
Duke University Medical Center Durham, North Carolina  27710
University of Arizona Health Sciences Center Tucson, Arizona  85724
Children's Hospital & Research Center Oakland Oakland, California  94609
University of Louisville Louisville, Kentucky  40202
University of Chicago Chicago, Illinois  60637
Moffitt Cancer Center Tampa, Florida  33612
Oregon Health and Science University Portland, Oregon  97201
Georgetown University Hospital Washington, District of Columbia  20007
Mayo Clinic- Jacksonville Jacksonville, Florida  32224
Florida Hospital Orlando, Florida  32803
University of Maryland Medical Center Baltimore, Maryland  21201-1595
Stanford Hospital and Clinics Stanford, California  94305
The Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Northside Hospital Atlanta, Georgia  30342
University of North Carolina at Chapel Hill Chapel Hill, North Carolina  27599
Penn State Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
The Children'S Hospital Denver, Colorado  80218
Nebraska Medical Center Omaha, Nebraska  68198
Cincinnati Children's Hospital Cincinnati, Ohio  45229
University of Michigan Health System Ann Arbor, Michigan  
University of Iowa Hospitals & Clinics Iowa City, Iowa  52242
University of Minnesota Medical Center, Fairview Minneapolis, Minnesota  55455
Children's Mercy Hospital and Clinics Kansas City, Missouri  64108
Boston Children's Hospital Boston, Massachusetts  02115
Hawaii Pacific Health Lihue, Hawaii  96766
Helen DeVos Children's Hospital Grand Rapids, Michigan  49503
Cardinal Glennon Children's Medical Center St. Louis, Missouri  63104
Mayo Clinic -Hematology/Oncology Scottsdale, Arizona  85259
The University of California, San Diego La Jolla, California  92037
University of California San Francisco Children's Hospital San Francisco, California  94143
Indiana Bone Marrow Transplant (St. Francis Hospital) Beechgrove, Indiana  46107
Indiana University/Riley Hospital for Children Indianapolis, Indiana  46202
Children's Hospital New Orleans New Orleans, Louisiana  70118
Rochester Methodist Hospital, Mayo Clinic Rochester, Minnesota  55905
Children's Hospitals and Clinics of Minnesota- St. Paul Saint Paul, Minnesota  55102
Cohen Children's Medical Center New Hyde Park, New York  11040
Columbia University Medical Center/ New York Presbyterian Hospital New York, New York  10032
New York Presbyterian Hospital- Weill Cornell Medical College New York, New York  10065
The University of Oklahoma Health Science Center Oklahoma City, Oklahoma  73104
Avera Hematology & Transplant Clinic Sioux Falls, South Dakota  57105
Cook Children's Hospital Fort Worth, Texas  76104
Methodist Hospital (Texas Transplant) San Antonio, Texas  78229
Providence Sacred Heart Children's Hospital Spokane, Washington  99220
Wolfson Children's Hospital Jacksonville, Florida  32207
Jackson Memorial- University of Miami Health System- Pediatrics Miami, Florida  33136
Lurie Children's Hospital of Chicago Chicago, Illinois  60611
The University of Utah- Primary Children's Medical Center Salt Lake City, Utah  84113
Seattle Children's Hospital/ University of Washington Medical Center Seattle, Washington  98105
Medical College of Wisconsin/ Children's Hospitalof Wisconsin Milwaukee, Wisconsin  53226