Compassionate Use of Defibrotide for Patients With Veno-occlusive Disease of the Liver
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|ClinicalTrials.gov Identifier: NCT00143546|
Expanded Access Status : No longer available
First Posted : September 2, 2005
Last Update Posted : April 25, 2017
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.
|Condition or disease||Intervention/treatment|
|Hepatic Veno-occlusive Disease||Drug: Defibrotide|
|Study Type :||Expanded Access|
|Official Title:||Compassionate Use of Defibrotide for Patients With Veno-Occlusive Disease|
|Study Start Date :||November 2003|
- Drug: Defibrotide
Defibrotide to be administered approximately every 6 hours at an initial dose of 6.25 mg/kg/dose. Subsequent doses will be escalated with a plateau of 15 mg/kg/dose (or 60 mg/kg/day total). For patients with persistent VOD, the dose may be escalated by 10 mg/kg/day as needed to a maximum of 110 mg/kg/day total.Other Names:
- Veno-occlusive disease
- Hepatic veno-occlusive disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|