Assessment of the Efficacy Safety and Pharmacokinetics of Orally Administered Epetraborole in Patients with Treatment-refractory Mycobacterium avium Complex Lung Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Mycobacterium Avium Complex
  • Age: Between 18 Year(s) - 99 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Willing and able to provide written informed consent.

You may not be eligible for this study if the following are true:

    1. Patients with any of the following:
      • Predominately fibrocavitary MAC lung disease or cavity >3 cm in diameter;
      • Treatment-refractory MACK lung disease > 5 years;
      • Cystic fibrosis;
      • Active allergic bronchopulmonary mycosis;
      • Anticipated surgery for treatment of MAC lung disease;
      • Disseminated MAC infection;
      • Concomitant pulmonary infection requiring antimicrobial therapy.
    2. Active pulmonary malignancy (primary or metastatic) or any malignancy that required or would require chemotherapy or radiation therapy within 1 year prior to randomization through the last follow up visit.
    3. Creatine clearance < 50 mL/min.
    4. Hemoglobin < 10 g/dl; donation of blood or plasma within 28 days prior to randomization or symptomatic loss of blood within 28 days prior to randomization.
    5. Severe hemoptysis (> 100 mL) within 28 days prior to randomization.
    6. Severe hepatic impairment.
    7. Patients who are pregnant or breastfeeding.
    8. Immunodeficiency.
    9. Patients with an anticipated start of new non-study antimycobacterial therapy to be administered anytime between Screening and Month 6 of this study.

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