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Multicenter Interventional Lymphangioleiomyomatosis (LAM) Early Disease Trial

NCT03150914 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-24

No results posted yet for this study

Summary

This is a study to determine if early, long-term low dose sirolimus is effective for preventing progression to more advanced stages.

Conditions

  • LAM
  • Lymphangioleiomyomatosis

Interventions

DRUG

Sirolimus

mTOR inhibitor or placebo

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • The LAM Foundation

    collaborator OTHER

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Francis X. McCormack, M.D. · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150914 on ClinicalTrials.gov