Trials / Completed
CompletedNCT02851407
Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 372 (actual)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- 1 Month
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Defibrotide | |
| OTHER | Best Supportive Care |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2020-10-20
- Completion
- 2020-10-20
- First posted
- 2016-08-01
- Last updated
- 2022-03-02
- Results posted
- 2022-03-02
Locations
114 sites across 14 countries: United States, Australia, Belgium, Canada, France, Germany, Israel, Italy, Japan, New Zealand, South Korea, Spain, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02851407. Inclusion in this directory is not an endorsement.