Compassionate Use of Defibrotide for Patients With Veno-occlusive Disease of the Liver

NO_LONGER_AVAILABLE

Conditions studied: Hepatic Veno-occlusive Disease

In brief

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.

Key facts

Study ID

NCT00143546

Run by

St. Jude Children's Research Hospital

Starts

2003-11-01

Last updated by the study team

2017-04-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with clinical or pathologic diagnosis of veno-occlusive disease. The following criteria will be used:
• Hyperbilirubinemia (greater than or equal to 2mg/dl) and two of the following: (hepatomegaly, ascites, or weight gain [greater than or equal to 5% of baseline]); OR,
• Patient who do not fulfill criteria in #1 but who have pathologic or radiographic evidence of VOD.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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