Compassionate Use of Defibrotide for Patients With Veno-occlusive Disease of the Liver
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.
|Study Type:||Expanded Access What is Expanded Access?|
|Official Title:||Compassionate Use of Defibrotide for Patients With Veno-Occlusive Disease|
|Study Start Date:||November 2003|
- Veno-occlusive disease
- Hepatic veno-occlusive disease.
Secondary objectives of this protocol include the following:
- To describe the toxicities of defibrotide in patients with VOD.
- To describe the response rate of VOD in patients receiving defibrotide.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143546
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Wing Leung, M.D.||St. Jude Children's Research Hospital|