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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 UniversityBaltimore, Maryland  21205
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Cleveland Clinic FoundationCleveland, Ohio  44195
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of California Davis Medical CenterSacramento, California  95817
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University Hospitals of ClevelandCleveland, Ohio  44106
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Rochester Medical CenterRochester, New York  14642
Hackensack University Medical CenterHackensack, New Jersey  07601
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Texas Children's Cancer CenterHouston, Texas  77030-2399
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Yale Cancer CenterNew Haven, Connecticut  06520-8028
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Akron Children's HospitalAkron, Ohio  44308-1062
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Massachusetts General HospitalBoston, Massachusetts  02114-2617
City of HopeDuarte, California  91010
Children's Medical Center of DallasDallas, Texas  75235
Children's Hospital of AlabamaBirmingham, Alabama  35233
Duke University Medical CenterDurham, North Carolina  27710
University of Arizona Health Sciences CenterTucson, Arizona  85724
Children's Hospital & Research Center OaklandOakland, California  94609
University of LouisvilleLouisville, Kentucky  40202
University of ChicagoChicago, Illinois  60637
Moffitt Cancer CenterTampa, Florida  33612
Oregon Health and Science UniversityPortland, Oregon  97201
Georgetown University HospitalWashington, District of Columbia  20007
Mayo Clinic- JacksonvilleJacksonville, Florida  32224
Florida HospitalOrlando, Florida  32803
University of Maryland Medical CenterBaltimore, Maryland  21201-1595
Stanford Hospital and ClinicsStanford, California  94305
The Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Northside HospitalAtlanta, Georgia  30342
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
The Children'S HospitalDenver, Colorado  80218
Nebraska Medical CenterOmaha, Nebraska  68198
Cincinnati Children's HospitalCincinnati, Ohio  45229
University of Michigan Health SystemAnn Arbor, Michigan  
University of Iowa Hospitals & ClinicsIowa City, Iowa  52242
University of Minnesota Medical Center, FairviewMinneapolis, Minnesota  55455
Children's Mercy Hospital and ClinicsKansas City, Missouri  64108
Boston Children's HospitalBoston, Massachusetts  02115
Hawaii Pacific HealthLihue, Hawaii  96766
Helen DeVos Children's HospitalGrand Rapids, Michigan  49503
Cardinal Glennon Children's Medical CenterSt. Louis, Missouri  63104
Mayo Clinic -Hematology/OncologyScottsdale, Arizona  85259
The University of California, San DiegoLa Jolla, California  92037
University of California San Francisco Children's HospitalSan Francisco, California  94143
Indiana Bone Marrow Transplant (St. Francis Hospital)Beechgrove, Indiana  46107
Indiana University/Riley Hospital for ChildrenIndianapolis, Indiana  46202
Children's Hospital New OrleansNew Orleans, Louisiana  70118
Rochester Methodist Hospital, Mayo ClinicRochester, Minnesota  55905
Children's Hospitals and Clinics of Minnesota- St. PaulSaint Paul, Minnesota  55102
Cohen Children's Medical CenterNew Hyde Park, New York  11040
Columbia University Medical Center/ New York Presbyterian HospitalNew York, New York  10032
New York Presbyterian Hospital- Weill Cornell Medical CollegeNew York, New York  10065
The University of Oklahoma Health Science CenterOklahoma City, Oklahoma  73104
Avera Hematology & Transplant ClinicSioux Falls, South Dakota  57105
Cook Children's HospitalFort Worth, Texas  76104
Methodist Hospital (Texas Transplant)San Antonio, Texas  78229
Providence Sacred Heart Children's HospitalSpokane, Washington  99220
Wolfson Children's HospitalJacksonville, Florida  32207
Jackson Memorial- University of Miami Health System- PediatricsMiami, Florida  33136
Lurie Children's Hospital of ChicagoChicago, Illinois  60611
The University of Utah- Primary Children's Medical CenterSalt Lake City, Utah  84113
Seattle Children's Hospital/ University of Washington Medical CenterSeattle, Washington  98105
Medical College of Wisconsin/ Children's Hospitalof WisconsinMilwaukee, Wisconsin  53226