clinical trial · NCT04630145
A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
Janssen Pharmaceutical K.K.·phase3·completed·n = 129
Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)BedaquilineClarithromycinEthambutolRifampicinRifabutin
brief summary
The purpose of the study is to evaluate the efficacy of bedaquiline (BDQ) compared with rifamycin when administered as part of a treatment regimen with clarithromycin (CAM) and ethambutol (EB) in adult participants with treatment-refractory Mycobacterium avium complex-lung disease (MAC-LD) at Week 24 for microbiological assessment in mycobacteria growth indicator tube (MGIT).
started
Jan 8, 2021
primary completion
Nov 6, 2024
completion
Nov 14, 2025
last updated
Apr 15, 2026
official title
A Phase 2/3, Multicenter, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol