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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.

Detailed Summary:
Sponsor: Jazz Pharmaceuticals

Current Primary Outcome: Survival at Day +100 or from HSCT or 100 days from start of chemotherapy [ Time Frame: Day +100 from HSCT or 100 days from start of chemotherapy ]

Original Primary Outcome: Complete response of VOD [ Time Frame: D+100 from SCT ]

Current Secondary Outcome: Tolerability & Safety Data from Patients with VOD [ Time Frame: From time of Consent to 30 Days Post of Last Administration of Study Drug ]

Original Secondary Outcome: Survival [ Time Frame: D+100 ]

Information By: Jazz Pharmaceuticals

Dates:
Date Received: February 25, 2008
Date Started: December 2007
Date Completion:
Last Updated: January 20, 2017
Last Verified: January 2017