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NCT00628498 · ClinicalTrials.gov registry record · Phase 3
Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study
A Phase 3 study of Hepatic Veno-Occlusive Disease, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,206
- Enrollment target
- 20
- Study locations
NCT00628498: Completed Phase 3 study of Hepatic Veno-Occlusive Disease, sponsored by Jazz Pharmaceuticals.
NCT00628498 is a Phase 3 study of Hepatic Veno-Occlusive Disease that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 1,206 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00628498, a Phase 3 study of Hepatic Veno-Occlusive Disease, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,206 participants
- Enrollment target
- 20
- Study locations
Study Summary
Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available to patients in the U.S.
Conditions Studied
Interventions
- DRUG Defibrotide
Study Locations (20)
California
- City of Hope Medical Center - Duarte
- The University of California, San Diego - La Jolla
- Loma Linda University - Loma Linda
- Long Beach Memorial Medical Center - Long Beach
- Children's Hospital of Los Angeles - Los Angeles
- Children's Hospital & Research Center Oakland - Oakland
- Children's Hospital of Orange County (CHOC) - Orange
- Sutter Institute for Medical Research - Sacramento
- University of California Davis Health System - Sacramento
- Rady's Children's Hospital - San Diego - San Diego
- University of California San Francisco Medical Center - San Francisco
- Stanford University Medical Center - Stanford
Arizona
- Phoenix Children's Hospital - Phoenix
- Mayo Clinic Cancer Center - Phoenix
- Arizona Oncology - Scottsdale
- University Medical Center - Tucson
Colorado
- Children's Hospital Colorado - Aurora
- US Oncology - Denver - Denver
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- University of Arkansas for Medical Services - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,206 participants |
| Start Date | 2007-12 |
| Est. Completion | 2016-09 |
| Phase | Phase 3 |
What the finished NCT00628498 record still lists
NCT00628498 is an interventional study that assigns participants to a tested intervention. Its 1,206 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% higher).
The record links to 1 condition, with Hepatic Veno-Occlusive Disease appearing as the primary indexed condition, and to 1 intervention - of which Defibrotide is the first listed.
NCT00628498 names 20 study sites across 5 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT00628498 about?
NCT00628498 is a clinical study titled "Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study". Single arm, open-label study to provide Defibrotide to patients diagnosed with VOD. Defibrotide is no longer available though the Emergency Use IND mechanism (also known as compassionate use, or single patient named use). This protocol is the only mechanism by which Defibrotide can be made available...
What is the current status of trial NCT00628498?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,206 participants. The study started on 2007-12. Estimated completion is 2016-09.
What conditions does trial NCT00628498 study?
This clinical trial studies the following conditions: Hepatic Veno-Occlusive Disease.
What interventions are being tested in trial NCT00628498?
The interventions under investigation include: Defibrotide (DRUG).
Who is sponsoring clinical trial NCT00628498?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00628498 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00628498's enrollment target sits among peer trials
1,206 219th of 2000 higher than 1,782 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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