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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 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 134 participants.
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.
Interventions
- DRUG Defibrotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2006-07 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00358501
The ClinicalTrials.gov registry entry for NCT00358501 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Defibrotide is the first listed.
NCT00358501 reports 0 study locations.
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.
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