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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: Completed Phase 2 study, sponsored by University of Cincinnati.
NCT03253913 is a Phase 2 study that has completed, run by University of Cincinnati. 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
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.
Primary Outcome
Change in serum VEGF-D level in pg/ml after treatment with a combination of resveratrol and sirolimus as compared to the historical VEGF-D level in patients on a stable dose of sirolimus alone. Baseline VEGF-D values represent serum VEGF-D levels on stable dose of sirolimus alone prior to starting study drug.
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 |
What the finished NCT03253913 record still lists
NCT03253913 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 2 interventions - of which Sirolimus is the first listed.
NCT03253913 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03253913'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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