Clinical Trial: Compassionate Use of Defibrotide for Patients With Veno-occlusive Disease of the Liver
Study Status: No longer available
Recruit Status: No longer available
Study Type: Expanded Access
Official Title: Compassionate Use of Defibrotide for Patients With Veno-Occlusive Disease
Brief 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.
Detailed Summary:
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.
Sponsor: St. Jude Children's Research Hospital
Current Primary Outcome:
Original Primary Outcome:
- To provide defibrotide to patients with severe veno-occlusive disease of the liver.
- To describe the effects (good and bad) of defibrotide in patients with veno-occlusive disease.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: St. Jude Children's Research Hospital
Dates:
Date Received: September 1, 2005
Date Started: November 2003
Date Completion:
Last Updated: April 24, 2017
Last Verified: April 2017
