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)

  • STATUS
    Recruiting
  • End date
    Jun 29, 2023
  • participants needed
    180
  • sponsor
    Janssen Pharmaceutical K.K.
Updated on 26 April 2021

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).

Details
Condition Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD), Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD), Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD), Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD), Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD), Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD), Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD), Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
Treatment rifabutin, rifampicin, ethambutol, bedaquiline, clarithromycin
Clinical Study IdentifierNCT04630145
SponsorJanssen Pharmaceutical K.K.
Last Modified on26 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 20 yrs and 79 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)??
Has body weight greater than or equal to (>=) 40 kilograms (kg) at screening and on Day 1
Has radiological evidence consistent with nontuberculous mycobacterial lung disease (NTM-LD) based on a chest Computed Tomography (CT) scan taken within 6 months prior to screening or at screening
Has at least 2 positive sputum cultures of Mycobacterium avium complex (MAC) (sputum cultures to be taken at least 4 weeks apart): one obtained within 12 months prior to screening, which was documented while being treated for Mycobacterium avium complex lung disease (MAC-LD) for a total of at least 6 months and no longer than 24 months; and one at screening (by central microbiology laboratory)
Received at least 6 months and no more than 24 months of consecutive MAC-LD treatment (at least 2 antibiotics for MAC, including a macrolide), that is either ongoing or has stopped within 12 months prior to screening
No presence of cognitive dysfunction that would impact the completion of the patient reported outcome (PRO) assessments

Exclusion Criteria

Had previous exposure to bedaquiline (BDQ)
Has active Tuberculosis (TB) disease
Has cystic fibrosis, medically unstable respiratory disease (for example, chronic obstructive pulmonary disease, bronchiectasis, asthma)
Has one or more cavities >=2 centimeter (cm) in diameter on a chest CT scan taken within 6 months prior to screening or at screening
Treatment already includes an injectable/inhaled aminoglycoside within 3 months prior to screening or the investigator deems the participant to be a candidate for an aminoglycoside at screening
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