Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study
Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study
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.
Inclusion Criteria:
Entry criteria include the following:
Clinical diagnosis of VOD, made by Baltimore Criteria, Modified Seattle Criteria, or biopsy proven:
1.1 Baltimore Criteria- Bilirubin ≥2 mg/dL and at least 2 of the following clinical findings:
1.2 Modified Seattle Criteria: At least two of the following
1.3 Patients that do not meet the Baltimore Criteria or Modified Seattle Criteria and have biopsy proven VOD are eligible.
Patient must also provide written informed consent.
Exclusion Criteria:
Indianapolis, Indiana 46237, United States
New Orleans, Louisiana 70112, United States
Minneapolis, Minnesota 55404, United States
Kansas City, Missouri 64108, United States
St Louis, Missouri 63104, United States
Hackensack, New Jersey 07601, United States
New York, New York 10032, United States
New York, New York 10065, United States
Rochester, New York 14642, United States
Cleveland, Ohio 44106, United States
Columbus, Ohio 43205, United States
Portland, Oregon 97239, United States
Memphis, Tennessee 38105, United States
Seattle, Washington 98109, United States
Spokane, Washington 99204, United States
Morgantown, West Virginia 26505, United States
Madison, Wisconsin 53792, United States