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Anti-infective agent

Clofazimine for Mycobacterium Avium Complex Infection

Phase 2
Recruiting
Led By Kevin Winthrop, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet ATS/IDSA 2007 pulmonary disease criteria
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up promis fatigue 7a short form results examined for change from baseline at 24 weeks
Awards & highlights

Study Summary

This trial will test the effectiveness and safety of clofazimine to treat MAC lung disease.

Who is the study for?
Adults over 18 with pulmonary Mycobacterium Avium Complex (MAC) infection, who've had at least two positive MAC sputum cultures in the past year are eligible. They must be able to consent and not have severe lung disease, HIV, active tuberculosis or cancer treatments within a year, high heart rhythm risk (QT prolongation), or use certain drugs.Check my eligibility
What is being tested?
The trial is testing clofazimine's effectiveness and safety against a sugar pill for treating MAC lung disease. Participants will randomly receive either clofazimine or a placebo to compare outcomes between the two groups.See study design
What are the potential side effects?
Clofazimine may cause side effects like stomach pain, nausea, skin discoloration and itching. It can also potentially affect heart rhythms and interact with other medications leading to more serious issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung condition meets specific health standards.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~promis fatigue 7a short form results examined for change from baseline at 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and promis fatigue 7a short form results examined for change from baseline at 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline sputum culture at 24 weeks
Secondary outcome measures
Change from Baseline 6 Minute Walk Test at 24 weeks
C-reactive protein
Change from Baseline CT scan at 24 weeks
+10 more

Side effects data

From 2023 Phase 3 trial • 588 Patients • NCT02409290
31%
Metabolism and nutrition disorders
31%
Investigations
9%
Hepatic disorders (SMQ)
9%
Psychiatric disorders
9%
Gastrointestinal disorders
6%
Hearing and vestibular disorders (SMQ)
6%
Torsade de pointes/QT prolongation (SMQ)
6%
Musculoskeletal and connective tissue disorders
3%
Vascular disorders
3%
Pregnancy, puerperium and perinatal conditions
3%
General disorders and administration site conditions
3%
Social circumstances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Regimen A (Long Regimen)
Regimen C (Oral Regimen)
Regimen B (Control Regimen)
Regimen D (6-month Regimen)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: clofazimineExperimental Treatment1 Intervention
Participants receive lamprene
Group II: sugar pillPlacebo Group1 Intervention
Participants receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clofazimine
2022
Completed Phase 4
~2900

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,280 Previous Clinical Trials
5,487,731 Total Patients Enrolled
University of South FloridaOTHER
416 Previous Clinical Trials
188,863 Total Patients Enrolled
The University of Texas Health Science Center at TylerOTHER
14 Previous Clinical Trials
25,586 Total Patients Enrolled

Media Library

Clofazimine (Anti-infective agent) Clinical Trial Eligibility Overview. Trial Name: NCT02968212 — Phase 2
Mycobacterium Avium Complex Infection Research Study Groups: clofazimine, sugar pill
Mycobacterium Avium Complex Infection Clinical Trial 2023: Clofazimine Highlights & Side Effects. Trial Name: NCT02968212 — Phase 2
Clofazimine (Anti-infective agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02968212 — Phase 2
~6 spots leftby Dec 2024
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