Clinical trial
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in…
NCT00358501 · Jazz Pharmaceuticals, Industry · Completed
Key facts
| NCT number | NCT00358501 |
|---|---|
| Title | Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients |
| Official title | Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients: A Historically-Controlled, Multi-Center Phase 3 Study to Determine Safety & Efficacy |
| Lead sponsor | Jazz Pharmaceuticals, Industry |
| Collaborators | FDA Office of Orphan Products Development U.S. Fed |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Severe Hepatic Veno-Occlusive Disease |
| Intervention type | Drug |
| Interventions | Defibrotide |
| Enrollment | 134 |
| Start date | Jul 1, 2006 |
| Primary completion | Sep 1, 2008 |
| Completion | Mar 1, 2015 |
| First posted | Aug 1, 2006 |
| Last update posted | Jan 30, 2017 |
| Countries | Canada, United States |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: