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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 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 25 participants.
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.
Interventions
- DRUG Defibrotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2020-07-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03384693
The ClinicalTrials.gov registry entry for NCT03384693 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Defibrotide is the first listed.
NCT03384693 reports 0 study locations.
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.
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