A Phase 2/3 Randomized Double-blind Placebo-controlled Multicenter Prospective Study to Assess the Efficacy Safety and Pharmacokinetics of Orally Administered Epetraborole in Patients with Treatment-refractory Mycobacterium avium Complex Lung Disease (MACrO2)
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:
- Willing and able to provide written informed consent.
You may not be eligible for this study if the following are true:
-
- 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.
- 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.
- Creatine clearance < 50 mL/min.
- 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.
- Severe hemoptysis (> 100 mL) within 28 days prior to randomization.
- Severe hepatic impairment.
- Patients who are pregnant or breastfeeding.
- Immunodeficiency.
- Patients with an anticipated start of new non-study antimycobacterial therapy to be administered anytime between Screening and Month 6 of this study.
- Patients with any of the following:
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.