View Clinical Trial (Medical Research Study)
Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study (Under CFR 312.34)
| City: |
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Hershey |
| State: |
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Pennsylvania |
| Zip Code: |
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17033 |
| Conditions: |
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Hepatic Veno-Occlusive Disease |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
Entry criteria include both of the following:
1.1 Clinical diagnosis of VOD, defined by jaundice (bilirubin ≥2 mg/dL) and at least 2 of
the following clinical findings:
- Ascites
- 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.
Patients that do not meet the criteria in Section 1.1 (i.e. have two of the major criteria
but not three) and have biopsy proven VOD are eligible.
1.2 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.
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| NCT ID: |
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NCT00628498 |
| Primary Contact: |
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Study Director
Carin Heringa, M.D.
Gentium, S.p.A.
Fahmina Rahman, MPH
Phone: 1-312-706-6261
Email: 0265-002Gentium@iconplc.com
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| Backup Contact: |
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Email: ahannah@gentium.it
Alison Hannah, M.D.
Phone: 707.824.4684
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| Location Contact: |
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Hershey, Pennsylvania 17033
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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