Defibrotide for Patients with Hepatic Veno-Occlusive Disease (VOD): A Treatment IND Study (UNDER CFR 312.34)
Conditions
Hepatic Veno-Occlusive Disease
What is the purpose of this trial?
This is a multicenter, single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. The primary objective of this Treatment IND is to provide Defibrotide under 21 CFR 312.34 (Treatment use of an investigational new drug). The Treatment IND will collect additional usage, tolerability and safety data from patients with VOD. Efficacy analysis will be done for patients who meet eligibility criteria for the previous Phase 3 study Protocol 2005-01 Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoietic Stem Cell Transplant Patients: A Historically Controlled, Multi-Center Phase 3 Study to Determine Safety and Efficacy”. Additional safety data collected from all patients who receive a dose of Defibrotide will be used to support the New Drug Application and the labeling for Defibrotide.
Participation Guidelines
- Age:
- 18 Years and older
- Gender:
- Both
Click here for detailed information about who can participate in this trial.
- Sponsor:
- Gentium S.P.A.
- Dates:
- February 2012
- Last Updated:
- Study HIC#:
- 1202009694
Clinicaltrials.gov ID: Yale5273815
