Defibrotide Compassionate Use for Patients With Life Threatening Veno-Occlusive Disease of the Liver

Summary

Severe veno-occlusive disease (VOD) of the liver is a life threatening complication of blood and marrow transplantation. Treatment with currently available (Food and Drug Administration \[FDA\] approved) agents fails in most cases. Recently conducted clinical studies indicate that patients benefit from defibrotide, a non-FDA approved agent. This protocol has been developed not with a research intent, but rather to ensure that defibrotide is used by the blood and marrow transplant programs at Children's Healthcare of Atlanta and at Emory University in a safe, effective and ethical manner.

Timeline

Start

2005-11

Primary completion

2009-06

Completion

2009-06

Drugs

Indications