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NCT00358501 · ClinicalTrials.gov registry record · Phase 3
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 134
- Enrollment target
NCT00358501: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT00358501 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 134 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00358501, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 134 participants
- Enrollment target
Study Summary
The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25 mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2) evaluate serum and endothelial markers of veno-occlusive disease (VOD) through the analysis of blood samples.
Primary Outcome
The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.
Interventions
- DRUG Defibrotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2006-07 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT00358501 record still lists
NCT00358501 is an interventional study that assigns participants to a tested intervention. The registered 134 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 (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Defibrotide is the first listed.
NCT00358501 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00358501 about?
NCT00358501 is a clinical study titled "Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients". The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25 mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2) evaluate serum and endothelial markers of veno-occlusive disease (VOD) through the analysis of blood samples.
What is the current status of trial NCT00358501?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 2006-07. Estimated completion is 2015-03.
What interventions are being tested in trial NCT00358501?
The interventions under investigation include: Defibrotide (DRUG).
Who is sponsoring clinical trial NCT00358501?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00358501's enrollment target sits among peer trials
134 1585th of 2000 higher than 413 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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