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NCT03253913 · ClinicalTrials.gov registry record · Phase 2
Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial
A Phase 2 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT03253913 is a Phase 2 study that has completed, run by University of Cincinnati. The registered enrollment target is 25 participants.
The verdict
NCT03253913, a Phase 2 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
RESULT is a phase II dose-escalating, open-label, safety and efficacy study to determine if there is a potential benefit of resveratrol in combination with sirolimus in patients with lymphangioleiomyomatosis (LAM). The primary study objective is to assess the change in serum vascular endothelial growth factor-D (VEGF-D) level after 24 weeks of treatment with a combination of resveratrol and sirolimus as compared to the VEGF-D level in patients on a stable dose of sirolimus alone. The secondary objectives of this study include an assessment of the safety and adverse effect profile of combined resveratrol and sirolimus in adult patients with LAM, and to determine the effect of treatment with a combination of resveratrol and sirolimus on changes in lung function and quality of life.
Interventions
- DRUG Sirolimus
- DRUG Resveratrol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-03-31 |
| Est. Completion | 2022-10-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03253913
The ClinicalTrials.gov registry entry for NCT03253913 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 Cincinnati, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sirolimus is the first listed.
NCT03253913 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03253913 about?
NCT03253913 is a clinical study titled "Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial". RESULT is a phase II dose-escalating, open-label, safety and efficacy study to determine if there is a potential benefit of resveratrol in combination with sirolimus in patients with lymphangioleiomyomatosis (LAM). The primary study objective is to assess the change in serum vascular endothelial gro...
What is the current status of trial NCT03253913?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2018-03-31. Estimated completion is 2022-10-15.
What interventions are being tested in trial NCT03253913?
The interventions under investigation include: Sirolimus (DRUG), Resveratrol (DRUG).
Who is sponsoring clinical trial NCT03253913?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
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