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

Veno-occlusive Disease Clinical Trial

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 and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant

Status Completed

Clinical Trial Summary

This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02851407
Study type	Interventional
Source	Jazz Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	September 1, 2016
Completion date	October 20, 2020

View Details

See also
Status	Clinical Trial	Phase
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Active, not recruiting	`NCT02338440` - Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT	Phase 2/Phase 3
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Completed	`NCT00003966` - Defibrotide in Treating Patients With Liver Damage Following Peripheral Stem Cell Transplantation	Phase 2
Completed	`NCT00006083` - Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter	Phase 3