Pooled Dose Response Analysis of Defibrotide in >1600 Patients for the Treatment of Hepatic Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome

Hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) is a potentially life-threatening complication of hematopoietic stem cell transplant (HSCT) conditioning. Severe cases, classically defined by the presence of multi-organ dysfunction (MOD), may be associated with >80% mortality. In the EU, defibrotide 25 mg/kg/day divided q6h is approved for treatment of severe hepatic VOD/SOS post-HSCT. In the US, defibrotide is available through an ongoing expanded-access protocol.