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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)

NCT04630145 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2026-04-15

Study results available
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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

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.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan clinical Trials · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-08
Primary Completion
2024-11-06
Completion
2025-11-14
FDA Drug
Yes

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630145 on ClinicalTrials.gov