Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01687179 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Sirolimus and Hydroxychloroquine in Women With Lymphangioleiomyomatosis
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01687179 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 14 participants.
The verdict
NCT01687179, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
Specific Aim 1: To investigate whether, in Lymphangioleiomyomatosis (LAM) patients, the combination of sirolimus and hydroxychloroquine is safe and well tolerated Specific Aim 2: To investigate whether, in LAM patients, 6 months of combination therapy with sirolimus and hydroxychloroquine results in improvement of indicators of disease, and whether the gains are sustained after stopping therapy. Specific Aim 3: To investigate the potential role of a LAM-specific peripheral blood signature to predict rates of disease progression and determine responsiveness to combination therapy. This will be a phase I dose escalation study of the combination of sirolimus (2 mg adjusted to keep trough levels between 5-15 ng/ml) and hydroxychloroquine (200 mg or 400 mg) taken orally daily. Up to 18 adult women with LAM will be enrolled.
Interventions
- DRUG "Sirolimus" and "Hydroxychloroquine" 200 mg
- DRUG "Sirolimus" and "Hydroxychloroquine" 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01687179
The ClinicalTrials.gov registry entry for NCT01687179 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which "Sirolimus" and "Hydroxychloroquine" 200 mg is the first listed.
NCT01687179 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01687179 about?
NCT01687179 is a clinical study titled "Safety Study of Sirolimus and Hydroxychloroquine in Women With Lymphangioleiomyomatosis". Specific Aim 1: To investigate whether, in Lymphangioleiomyomatosis (LAM) patients, the combination of sirolimus and hydroxychloroquine is safe and well tolerated Specific Aim 2: To investigate whether, in LAM patients, 6 months of combination therapy with sirolimus and hydroxychloroquine results i...
What is the current status of trial NCT01687179?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2012-09. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01687179?
The interventions under investigation include: "Sirolimus" and "Hydroxychloroquine" 200 mg (DRUG), "Sirolimus" and "Hydroxychloroquine" 400 mg (DRUG).
Who is sponsoring clinical trial NCT01687179?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.