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)

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)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)

Interventions

Type	Name	Description
DRUG	Bedaquiline	Participants will receive BDQ tablets only/
DRUG	Clarithromycin	Participants will receive CAM 400 or 500 mg twice a day.
DRUG	Ethambutol	Participants will receive 500 to 750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 mg/kg once a day.
DRUG	Rifampicin	Participants will receive daily dose is 450 mg (maximum 600 mg) RFP capsule once a day.
DRUG	Rifabutin	Participants will receive daily dose of RBT 300 mg or 150 mg capsules once a day.

Timeline

• Start date: 2021-01-08
• Primary completion: 2024-11-06
• Completion: 2025-11-14
• First posted: 2020-11-16
• Last updated: 2026-04-15
• Results posted: 2026-04-15

Locations

55 sites across 3 countries: Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study