Status:
COMPLETED
Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study
Lead Sponsor:
Jazz Pharmaceuticals
Conditions:
Hepatic Veno-Occlusive Disease
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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 singl...
Eligibility Criteria
Inclusion
- Entry criteria include the following:
- Clinical diagnosis of VOD, made by Baltimore Criteria, Modified Seattle Criteria, or biopsy proven:
- 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.
- 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
- 3 Patients that do not meet the Baltimore Criteria or Modified Seattle Criteria and have biopsy proven VOD are eligible.
- Patient must also provide written informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
1206 Patients enrolled
Trial Details
Trial ID
NCT00628498
Start Date
December 1 2007
End Date
September 1 2016
Last Update
November 30 2017
Active Locations (125)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Mayo Clinic Cancer Center
Phoenix, Arizona, United States, 85054
4
Arizona Oncology
Scottsdale, Arizona, United States, 85258