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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)

Janssen (J&J Innovative Medicine) logo

Janssen (J&J Innovative Medicine)

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

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

Treatments

Drug: Ethambutol
Drug: Rifabutin
Drug: Rifampicin
Drug: Bedaquiline
Drug: Clarithromycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT04630145
TMC207NTM3002 (Other Identifier)
CR108897

Details and patient eligibility

About

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).

Enrollment

129 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 one at screening (by central microbiology laboratory)
  • Received at least 6 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 injectable/inhaled aminoglycoside during screening period or at Day 1

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

129 participants in 2 patient groups

Group A: Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Experimental group
Description:
Participants will receive BDQ 400 milligrams (mg) (4\*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2\*100mg tablets) bi-weekly (biw) from Week 3 to 48 (maintenance phase) and CAM 400 mg or 500 mg twice daily (2\*200 mg tablets) along with EB 500-750 mg or 15 mg/kg once a day or maximum daily dose of 1.0 gram for up to Week 48.
Treatment:
Drug: Clarithromycin
Drug: Bedaquiline
Drug: Ethambutol
Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB
Active Comparator group
Description:
Participants will receive maximum of 4 capsules of RFP 450 mg daily (or maximum daily dose of 600 mg), CAM 400 mg or 500 mg (2\*200 mg tablets) twice a day along with EB 500-750 mg daily or 15 mg/kg once a day or maximum daily dose of 1.0 gram for up to Week 48, followed by 2 capsules of RBT 300 mg or 150 mg once a day.
Treatment:
Drug: Clarithromycin
Drug: Rifampicin
Drug: Rifabutin
Drug: Ethambutol

Trial contacts and locations

55

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Central trial contact

Study Contact

Data sourced from clinicaltrials.gov

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