Clinical Trial: Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult

Brief Summary: This study is to compare the efficacy and safety of defibrotide versus best supportive care in the prevention of hepatic veno-occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic stem cell transplant who are at high risk or very high risk of developing VOD.

Detailed Summary:
Sponsor: Jazz Pharmaceuticals

Current Primary Outcome: Veno-Occlusive Disease (VOD)-Free Survival at Day 30 Post-Hemotopoietic Stem Cell Transplant (HSCT) [ Time Frame: 30 Days Post-Transplant ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Veno-Occlusive Disease (VOD)-Free Survival at Day 100 Post-Hemotopoietic Stem Cell Transplant (HSCT) [ Time Frame: 100 Days Post-Transplant ]

Original Secondary Outcome: Same as current

Information By: Jazz Pharmaceuticals

Dates:
Date Received: July 27, 2016
Date Started: September 2016
Date Completion: February 2021
Last Updated: April 26, 2017
Last Verified: April 2017