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NCT02851407 · ClinicalTrials.gov registry record · Phase 3
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 study of Veno-occlusive Disease, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 372
- Enrollment target
- 20
- Study locations
NCT02851407: Completed Phase 3 study of Veno-occlusive Disease, sponsored by Jazz Pharmaceuticals.
NCT02851407 is a Phase 3 study of Veno-occlusive Disease that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 372 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02851407, a Phase 3 study of Veno-occlusive Disease, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 372 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
VOD-free survival is a composite of survival status and VOD occurrence as determined by modified Seattle criteria adjudicated by a blinded independent EPAC. An event is defined as a VOD diagnosis (as assessed by the EPAC) or death, whichever, is earlier, up to and including Day +30 post-HSCT. The values reported below are participants who did not experience VOD or death by Day +30 post-HSCT.
Conditions Studied
Interventions
- DRUG Defibrotide
- OTHER Best Supportive Care
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Stanford University - Palo Alto
- Rady Childrens Hospital San Diego - San Diego
- University of California San Francisco - San Francisco
New York
- Columbia University Medical Center - New York
- Weill Cornell Medical College - New York
- Memorial Sloan Kettering Cancer Center - New York
Arizona
- Phoenix Children's Hospital - Phoenix
- University of Arizona Cancer Center - Tucson
Florida
- Nicklaus Childrens Hospital - Miami
- Johns Hopkins All Children's Hospital - St. Petersburg
Massachusetts
- Tufts Floating Hospital for Children - Boston
- Dana Farber Cancer Institute - Boston
Alabama
- Children's Hospital of Alabama - Birmingham
Colorado
- Colorado Children's Hospital - Aurora
Delaware
- Alfred I Dupont Hospital For Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2020-10-20 |
| Phase | Phase 3 |
What the finished NCT02851407 record still lists
NCT02851407 is an interventional study that assigns participants to a tested intervention. The registered 372 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Veno-occlusive Disease appearing as the primary indexed condition, and to 2 interventions - of which Defibrotide is the first listed.
NCT02851407 names 20 study sites across 12 states, led by California, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT02851407 about?
NCT02851407 is a clinical study titled "Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients". 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 r...
What is the current status of trial NCT02851407?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 372 participants. The study started on 2016-09-01. Estimated completion is 2020-10-20.
What conditions does trial NCT02851407 study?
This clinical trial studies the following conditions: Veno-occlusive Disease.
What interventions are being tested in trial NCT02851407?
The interventions under investigation include: Defibrotide (DRUG), Best Supportive Care (OTHER).
Who is sponsoring clinical trial NCT02851407?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02851407 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02851407's enrollment target sits among peer trials
372 991st of 2000 higher than 1,009 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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