Compassionate Use of Defibrotide for Patients With Veno-occlusive Disease of the Liver
Status:
No longer available
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Veno-occlusive disease (VOD) of the liver is a significant complication for some patients
undergoing hematopoietic stem cell transplantation. This disease is thought to be a toxicity
secondary to chemotherapy or radiation-induced damage to the epithelial cells of the blood
vessels in the liver. VOD is categorized as mild, moderate or severe. Historically, there has
been no method to treat the disease. Recently, however, there have been investigations into
the use of a new agent called defibrotide.
The primary purpose of this protocol is to provide defibrotide to patients with severe VOD.
Because this drug has not been approved by the FDA, use of this medication under the auspices
of this IND treatment plan is for compassionate use only.