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ACTIVE NOT RECRUITING
NCT02968212
PHASE2

Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)

Sponsor: Oregon Health and Science University

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the clinical effectiveness and safety of clofazimine when used to treat Mycobacteria avium complex (MAC) lung disease. Funding Source - FDA OOPD

Official title: Phase 2 Study of Clofazimine for the Treatment of Pulmonary Mycobacterium Avium Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2017-04-11

Completion Date

2026-03

Last Updated

2025-09-05

Healthy Volunteers

No

Interventions

DRUG

Clofazimine

All participants in the experimental/treatment arm on this protocol will take a loading dose of 200 mg daily in soft capsule form of clofazimine for 16 weeks, dropping to 100 mg daily for the next 8 weeks.

OTHER

sugar pill

All participants in the placebo arm on this protocol will take placebo in soft capsule form daily dropping to a smaller dose after 16 weeks to mirror the treatment arm dosing.

Locations (7)

National Jewish Health

Denver, Colorado, United States

University of South Florida

Tampa, Florida, United States

University of Chicago

Chicago, Illinois, United States

Louisiana State University

Baton Rouge, Louisiana, United States

National Heart, Lung and Blood Institute

Bethesda, Maryland, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Texas Health Science Center

Tyler, Texas, United States