At a glance
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Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study
In Brief
A Phase 3 clinical trial evaluating Defibrotide for Hepatic Veno-Occlusive Disease. Completed, enrolled 1,206 participants across 125 sites.
Detailed 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 single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.
Study Details
Timeline
Interventions
Defibrotide is a single-stranded polydeoxyribonucleotide derived from porcine intestinal mucosa by controlled depolymerisation. Defibrotide has a complex mechanism of action with antithrombotic, anti-ischemic, anti-inflammatory, anti-adhesive and thrombolytic properties but no significant systemic anti-coagulant effects. Defibrotide is dose intravenously as a 2-hour infusion every 6 hours at a dose of 25 mg/kg/day. Recommended duration of therapy is 21 days.