Jazz Pharmaceuticals plc, a global biopharmaceutical company, announced that enrollment in the phase 3 clinical study of defibrotide for the prevention of hepatic veno-occlusive disease (VOD) post-hematopoietic stem-cell transplantation (HSCT) in high-risk or very high-risk patients is being discontinued.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that enrollment in the Phase 3 clinical study of defibrotide for the prevention of hepatic veno-occlusive disease (VOD) post-hematopoietic stem-cell transplantation (HSCT) in high-risk or very high-risk patients is being discontinued. Enrollment in the study was stopped early based on the recommendation from an Independent Data Monitoring Committee (IDMC), which concluded it would be highly unlikely to reach statistical significance for the primary endpoint of VOD-free survival at Day +30 post-HSCT in the final analysis if the study were to complete enrollment.