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NCT03384693 · ClinicalTrials.gov registry record · Phase 2
Defibrotide TMA Prophylaxis Pilot Trial
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT03384693: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT03384693 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03384693, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
Thrombotic microangiopathy (TMA) is a common complication in the stem cell transplant population. Certain populations within the hematopoietic stem cell transplant (HSCT) population are at a higher risk than others. Defibrotide is an endothelial stabilizing agent which may prevent the endothelial damage that triggers TMA in HSCT patients. The feasibility, safety, and efficacy of defibrotide prophylaxis in a pediatric transplant population is unknown. Twenty five patients age 0 to 30 years receiving autologous or allogeneic hematopoeitic stem cell transplant who meet TMA high risk criteria will be enrolled. Patients will receive Defibrotide for 28-35 days starting before conditioning, and will be closely monitored for any adverse events up through 6 months post-transplant. The feasibility of administering defibrotide will be evaluated as well as incidence of TMA.
Primary Outcome
Feasibility will be determined with regard to administration concurrently with chemotherapy and supportive medications before, during, and after stem cell infusion.
Interventions
- DRUG Defibrotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 2 |
What the finished NCT03384693 record still lists
NCT03384693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Defibrotide is the first listed.
NCT03384693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03384693 about?
NCT03384693 is a clinical study titled "Defibrotide TMA Prophylaxis Pilot Trial". Thrombotic microangiopathy (TMA) is a common complication in the stem cell transplant population. Certain populations within the hematopoietic stem cell transplant (HSCT) population are at a higher risk than others. Defibrotide is an endothelial stabilizing agent which may prevent the endothelial da...
What is the current status of trial NCT03384693?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2018-05-01. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT03384693?
The interventions under investigation include: Defibrotide (DRUG).
Who is sponsoring clinical trial NCT03384693?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03384693's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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