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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborators: FDA Office of Orphan Products Development; National Heart, Lung, and Blood Institute (NHLBI); National Institute of Allergy and Infectious Diseases (NIAID); National Jewish Health; The University of Texas Health Science Center at Tyler; University of Chicago
• Treatments: Clofazimine

Criteria

Inclusion Criteria:

• At least 2 positive MAC sputum cultures in the last 12 months with at least one obtained within 12 weeks prior to randomization

• Meet ATS/IDSA 2007 pulmonary disease criteria

• Adult males and females age 18 or over

• Ability to provide informed consent for the use of study drug

Exclusion Criteria:

• Any patient who is unwilling or unable to provide consent or to comply with this protocol

• Cavitary NTM disease

• Patients who are currently taking or within the prior 12 weeks received any of the following: bedaquiline, or any component of ATS/IDSA multi-drug recommended therapy (macrolide, ethambutol, rifampin) for MAC

• Current usage of inhaled amikacin, tobramycin, or gentamicin

• In the judgment of the investigator, the patient is not a candidate for observation (e.g. severe symptoms, extensive disease burden) but rather should be treated with standard multi-drug therapy

• Prior use of clofazimine that has resulted in an allergy to clofazimine or a severe adverse reaction

• Current usage of medications associated with QT prolongation (see Appendix C for full list of prohibited concomitant medications)

• Corrected QT (QTc) interval on electrocardiogram (ECG) > 470 ms for females or 450 ms for males, calculated using Fridericia's formula60,61

• Advanced lung disease (FEV<30%)

• HIV

• Active pulmonary tuberculosis requiring treatment at screening

• Active pulmonary malignancy or chemotherapy or radiation within 1 year of screening

• Use of chronic systemic corticosteroids at doses of 15 mg/day for more than 12 weeks

• Prior lung or other solid organ transplant

• Pregnancy, or breastfeeding that will continue during treatment