NCT00628498

Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,206 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Veno-Occlusive Disease

Interventions

Type	Name	Description
DRUG	Defibrotide	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.
DRUG	Defibrotide

Timeline

• Start date: 2007-12-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2008-03-05
• Last updated: 2017-11-30
• Results posted: 2017-11-30

Locations

125 sites across 1 country: United States