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CompletedNCT04630145Updated Apr 15, 2026Results posted

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 interventional study of Bedaquiline and Clarithromycin in Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD), sponsored by Janssen Pharmaceutical K.K.. Completed at 55 sites in 3 countries. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by Janssen Pharmaceutical K.K. (part of Johnson & Johnson) · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
129
Allocation
Randomized
Ages
20 Years to 79 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
03

In context

Lead sponsor

Janssen Pharmaceutical K.K. is the lead sponsor of 126 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.

Browse Janssen Pharmaceutical K.K. studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Had previous exposure to bedaquiline (BDQ)
  • Has active Tuberculosis (TB) disease
  • Has cystic fibrosis, medically unstable respiratory disease (for example, , 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
129 participants (actual)

Study arms

  • Experimental
    Group A: Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)

    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.

    Drug: Bedaquiline · Drug: Clarithromycin · Drug: Ethambutol

  • Active comparator
    Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB

    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.

    Drug: Clarithromycin · Drug: Ethambutol · Drug: Rifampicin · Drug: Rifabutin

Interventions

  • DrugBedaquiline

    Participants will receive BDQ tablets only/

  • DrugClarithromycin

    Participants will receive CAM 400 or 500 mg twice a day.

  • DrugEthambutol

    Participants will receive 500 to 750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 mg/kg once a day.

  • DrugRifampicin

    Participants will receive daily dose is 450 mg (maximum 600 mg) RFP capsule once a day.

  • DrugRifabutin

    Participants will receive daily dose of RBT 300 mg or 150 mg capsules once a day.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24

    Number of participants with sputum culture conversion in MGIT at Week 24 was reported. Sputum culture conversion was defined as 3 consecutive negative sputum cultures taken at least 25 days apart.

    Time frame: At Week 24

Secondary outcomes

  1. Number of Participants With Sputum Culture Conversion in 7H11 Agar Media at Week 24

    Number of participants with sputum culture conversion in 7H11 agar media at Week 24 was reported. Sputum culture conversion was defined as 3 consecutive negative sputum cultures taken at least 25 days apart based on actual collection dates.

    Time frame: At week 24

  2. Change From Baseline in Patient Reported Health Status on Total Score of St. George's Respiratory Questionnaire (SGRQ) at Week 24

    SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The composite total score is derived from the 3 domain scores. Each domain score and the total score has a range of 0 to 100, with 0 indicating the best possible quality of life. An increase in score indicates worsening health.

    Time frame: Baseline (Day 1), Week 24

  3. Percentage of Participants With Sputum Culture Conversion in MGIT at Week 48

    Time frame: At Week 48

  4. Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 48

    Time frame: At Week 48

  5. Percentage of Participants With Sputum Culture Negativity in MGIT

    Time frame: From Week 2 to Week 60

  6. Percentage of Participants With Sputum Culture Negativity in 7H10 or 7H11 Agar Media

    Time frame: From Week 2 to Week 60

  7. Time to Sputum Culture Conversion in MGIT up to Week 48

    Time frame: From baseline (Day 1) up to Week 48

  8. Time to Positivity in MGIT up to Week 48

    Time frame: From baseline (Day 1) up to Week 48

  9. Change From Baseline in Patient-Reported Health Status on Total Score of SGRQ at Weeks 48 and 60

    Time frame: Baseline (Day 1), Week 48 and Week 60

  10. Change From Baseline in Lung Function Parameters at Week 24

    Change from baseline in lung function parameters (Forced expiratory volume in one second, Forced vital capacity, Inspiratory capacity, Functional residual capacity, Total lung capacity) at Week 24 was reported.

    Time frame: Baseline (Day 1), Week 24

  11. Change From Baseline in Lung Function Parameters at Weeks 48 and 60

    Time frame: Baseline (Day 1), Week 48 and Week 60

  12. Percentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 24

    Percentage of participants who underwent a change in their Mycobacterium avium Complex-lung disease (MAC-LD) treatment regimen by Week 24 was reported.

    Time frame: Baseline (Day 1) up to Week 24

  13. Percentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 48 and Week 60

    Time frame: Baseline (Day 1), Week 48 and Week 60

  14. Percentage of Participants With Sputum Culture Conversion in MGIT at Week 60

    Time frame: At Week 60

  15. Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 60

    Time frame: At Week 60

  16. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: From Baseline (Day 1) up to Week 60

  17. Number of Participants With Clinically Significant Changes in Laboratory Tests

    Time frame: From Baseline (Day 1) up to Week 60

  18. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)

    Time frame: From Baseline (Day 1) up to Week 60

  19. Number of Participants With Clinically Significant Changes in Vital Signs

    Time frame: From Baseline (Day 1) up to Week 60

  20. Number of Participants With Clinically Significant Changes in Physical Examination

    Time frame: From Baseline (Day 1) up to Week 60

  21. Number of Participants With Clinically Significant Changes in Visual Examination

    Time frame: From Baseline (Day 1) up to Week 60

  22. Number of Participants With Clinically Significant Changes in Audiology

    Time frame: From Baseline (Day 1) up to Week 60

  23. Minimum Plasma Concentration Between 0 Hour and the Dosing Interval (Tau) (Ctrough) of BDQ and Its Metabolite M2

    Time frame: Day 1, Weeks 2, 8, 12, 24 and Week 48

  24. Minimum Plasma Concentration Between 0 Hour and the Dosing Interval (Tau) (Ctrough) of Clarithromycin and Its Metabolite 4-OH CAM

    Time frame: Day 1, Weeks 2, 8, 12 and 24

07

Results

Posted Apr 15, 2026

Participant flow

Participant flow — Overall Study
MilestoneRifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Started6465
Completed5963
Not completed52
Withdrew: Adverse event11
Withdrew: Physician decision20
Withdrew: Withdrawal by subject21

Outcome measures

PrimaryNumber of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24

Number of participants with sputum culture conversion in MGIT at Week 24 was reported. Sputum culture conversion was defined as 3 consecutive negative sputum cultures taken at least 25 days apart.

Time frame:
At Week 24
Reported as:
Count of participants · Participants
Number of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24
ParticipantsRifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Number of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24316
Statistical analysis
  • Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB) vs Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB) · Cochran-Mantel-Haenszel · p = =0.002 · Risk difference (rd): 19.7 · 95% CI 8.3 to 31.2
SecondaryNumber of Participants With Sputum Culture Conversion in 7H11 Agar Media at Week 24

Number of participants with sputum culture conversion in 7H11 agar media at Week 24 was reported. Sputum culture conversion was defined as 3 consecutive negative sputum cultures taken at least 25 days apart based on actual collection dates.

Time frame:
At week 24
Reported as:
Count of participants · Participants
Number of Participants With Sputum Culture Conversion in 7H11 Agar Media at Week 24
ParticipantsRifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Number of Participants With Sputum Culture Conversion in 7H11 Agar Media at Week 24316
SecondaryChange From Baseline in Patient Reported Health Status on Total Score of St. George's Respiratory Questionnaire (SGRQ) at Week 24

SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The composite total score is derived from the 3 domain scores. Each domain score and the total score has a range of 0 to 100, with 0 indicating the best possible quality of life. An increase in score indicates worsening health.

Time frame:
Baseline (Day 1), Week 24
Reported as:
Mean · Score on scale
Change From Baseline in Patient Reported Health Status on Total Score of St. George's Respiratory Questionnaire (SGRQ) at Week 24
Score on scaleRifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Change From Baseline in Patient Reported Health Status on Total Score of St. George's Respiratory Questionnaire (SGRQ) at Week 24-0.2 ± 8.10-3.8 ± 9.41
SecondaryPercentage of Participants With Sputum Culture Conversion in MGIT at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryPercentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 48
Time frame:
At Week 48

Results for this outcome have not been posted.

SecondaryPercentage of Participants With Sputum Culture Negativity in MGIT
Time frame:
From Week 2 to Week 60

Results for this outcome have not been posted.

SecondaryPercentage of Participants With Sputum Culture Negativity in 7H10 or 7H11 Agar Media
Time frame:
From Week 2 to Week 60

Results for this outcome have not been posted.

SecondaryTime to Sputum Culture Conversion in MGIT up to Week 48
Time frame:
From baseline (Day 1) up to Week 48

Results for this outcome have not been posted.

SecondaryTime to Positivity in MGIT up to Week 48
Time frame:
From baseline (Day 1) up to Week 48

Results for this outcome have not been posted.

SecondaryChange From Baseline in Patient-Reported Health Status on Total Score of SGRQ at Weeks 48 and 60
Time frame:
Baseline (Day 1), Week 48 and Week 60

Results for this outcome have not been posted.

SecondaryChange From Baseline in Lung Function Parameters at Week 24

Change from baseline in lung function parameters (Forced expiratory volume in one second, Forced vital capacity, Inspiratory capacity, Functional residual capacity, Total lung capacity) at Week 24 was reported.

Time frame:
Baseline (Day 1), Week 24
Reported as:
Mean · milliliters
Change From Baseline in Lung Function Parameters at Week 24
millilitersRifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Forced expiratory volume in one second-6.9 ± 83.36-14.3 ± 123.26
Forced vital capacity0.7 ± 103.99-16.0 ± 209.99
Inspiratory capacity-7.8 ± 212.55-37.7 ± 178.86
Functional residual capacity15.5 ± 330.4226.8 ± 271.52
Total lung capacity11.7 ± 336.36-1.6 ± 302.86
SecondaryChange From Baseline in Lung Function Parameters at Weeks 48 and 60
Time frame:
Baseline (Day 1), Week 48 and Week 60

Results for this outcome have not been posted.

SecondaryPercentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 24

Percentage of participants who underwent a change in their Mycobacterium avium Complex-lung disease (MAC-LD) treatment regimen by Week 24 was reported.

Time frame:
Baseline (Day 1) up to Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 24
percentage of participantsRifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Percentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 241.61.5
SecondaryPercentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 48 and Week 60
Time frame:
Baseline (Day 1), Week 48 and Week 60

Results for this outcome have not been posted.

SecondaryPercentage of Participants With Sputum Culture Conversion in MGIT at Week 60
Time frame:
At Week 60

Results for this outcome have not been posted.

SecondaryPercentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 60
Time frame:
At Week 60

Results for this outcome have not been posted.

SecondaryNumber of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame:
From Baseline (Day 1) up to Week 60

Results for this outcome have not been posted.

SecondaryNumber of Participants With Clinically Significant Changes in Laboratory Tests
Time frame:
From Baseline (Day 1) up to Week 60

Results for this outcome have not been posted.

SecondaryNumber of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Time frame:
From Baseline (Day 1) up to Week 60

Results for this outcome have not been posted.

SecondaryNumber of Participants With Clinically Significant Changes in Vital Signs
Time frame:
From Baseline (Day 1) up to Week 60

Results for this outcome have not been posted.

SecondaryNumber of Participants With Clinically Significant Changes in Physical Examination
Time frame:
From Baseline (Day 1) up to Week 60

Results for this outcome have not been posted.

SecondaryNumber of Participants With Clinically Significant Changes in Visual Examination
Time frame:
From Baseline (Day 1) up to Week 60

Results for this outcome have not been posted.

SecondaryNumber of Participants With Clinically Significant Changes in Audiology
Time frame:
From Baseline (Day 1) up to Week 60

Results for this outcome have not been posted.

SecondaryMinimum Plasma Concentration Between 0 Hour and the Dosing Interval (Tau) (Ctrough) of BDQ and Its Metabolite M2
Time frame:
Day 1, Weeks 2, 8, 12, 24 and Week 48

Results for this outcome have not been posted.

SecondaryMinimum Plasma Concentration Between 0 Hour and the Dosing Interval (Tau) (Ctrough) of Clarithromycin and Its Metabolite 4-OH CAM
Time frame:
Day 1, Weeks 2, 8, 12 and 24

Results for this outcome have not been posted.

Adverse events

Collected over All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)0/64 (0%)2/64 (3.1%)29/64 (45.3%)
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)0/65 (0%)4/65 (6.2%)42/65 (64.6%)
Most frequent serious events
Most frequent serious events
EventRifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
Atrial FibrillationCardiac disorders1/640/65
Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/640/65
Covid-19Infections and infestations0/641/65
PneumoniaInfections and infestations0/641/65
Pneumonia BacterialInfections and infestations0/641/65
UreterolithiasisRenal and urinary disorders0/641/65
Most frequent other events
Showing 10 of 14
Most frequent other events
EventRifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
DiarrhoeaGastrointestinal disorders3/6412/65
HeadacheNervous system disorders4/647/65
Covid-19Infections and infestations6/646/65
Back PainMusculoskeletal and connective tissue disorders4/646/65
Taste DisorderNervous system disorders0/646/65
RashSkin and subcutaneous tissue disorders5/645/65
NauseaGastrointestinal disorders3/645/65
MalaiseGeneral disorders2/645/65
PyrexiaGeneral disorders2/645/65
DysgeusiaNervous system disorders2/645/65

Baseline characteristics

Age, Continuous
Age, Continuous(years)Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)Total
Mean62.2 ± 11.464.6 ± 9.3463.4 ± 10.45
Age, Customized
Age, Customized(Participants)Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)Total
59 years and under232144
60 to 69 years231841
70 years and over182644
Sex: Female, Male
Sex: Female, Male(Participants)Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)Total
Female5452106
Male101323
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)Total
Hispanic or Latino000
Not Hispanic or Latino6465129
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)Total
American Indian or Alaska Native000
Asian6465129
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)Total
JAPAN5959118
SOUTH KOREA336
TAIWAN235
08

Study locations

55 sites
  • Fukuoka University Chikushi Hospital
    Chikushino-shi, 818-8502, Japan
  • St. Luke's International Hospital
    Chūōku, 104 8560, Japan
  • Fukui Prefectural Hospital
    Fukui-shi, 910-0846, Japan
  • National Hospital Organization Ibarakihigashi
    Funaishikawa, 319-1113, Japan
  • Gifu Prefectural General Medical Center
    Gifu, 500-8717, Japan
  • Hamamatsu Rosai Hospital
    Hamamatsu, 430-8525, Japan
  • Seirei Hamamatsu General Hospital
    Hamamatsu, 430-8558, Japan
  • National Hospital Organization Tenryu Hospital
    Hamamatue, 434-8511, Japan
  • Matsunami General Hospital
    Hashima-gun, 501-6062, Japan
  • Matsunami Health Promotion Clinic
    Hashimagun Kasamatsucho, 501-6062, Japan
  • National Hospital Organization Himeji Medical Center
    Himeji, 670-8520, Japan
  • Saitama Medical University Hospital
    Iruma-gun, 350-0495, Japan
  • National Hospital Organization Minami Kyoto Hospital
    Jōyō, 610-0113, Japan
  • Fukujuji Hospital
    Kiyose, 204-0022, Japan
  • Kobe City Medical Center West Hospital
    Kobe Nagata-Ku, 653-0013, Japan
  • National Hospital Organization Kochi National Hospital
    Kochi, 780-8077, Japan
  • National Hospital Organization Fukuoka Higashi Medical Center
    Koga, 811-3195, Japan
  • Saitama Prefectural Cardiovascular and Respiratory Center
    Kumagaya, 360-0197, Japan
  • Rakuwakai Otowa Hospital
    Kyoto, 607-8062, Japan
  • National Hospital Organization Kyoto Medical Center
    Kyoto, 612-8555, Japan
  • Matsusaka Municipal Hospital
    Matsusaka, 515-8544, Japan
  • Musashino Red Cross Hospital
    Musashino, 180-8610, Japan
  • Nagaoka Red Cross Hospital
    Nagaoka, 940-2085, Japan
  • Nagasaki University Hospital
    Nagasaki, 852-8501, Japan
  • Kojunkai Daido Clinic
    Nagoya, 457-8511, Japan
  • National Hospital Organization Nagoya Medical Center
    Nagoya, 460-0001, Japan
  • National Hospital Organization Nishiniigata Chuo Hospital
    Niigata, 950-2085, Japan
  • National Hospital Organization Omuta Hospital
    Omuta, 837-0911, Japan
  • National Hospital Organization Sagamihara National Hospital
    Sagamihara, 252-0392, Japan
  • Saitama City Hospital
    Saitama-shi, 336-8522, Japan
  • Kinki-chuo Chest Medical Center
    Sakai, 591-8555, Japan
  • Hokkaido Medical Center
    Sapporo Nishi-Ku, 063-0005, Japan
  • Tohoku Medical And Pharmaceutical University Hospital
    Sendai, 983-8512, Japan
  • National Hospital Organization Nara Medical Center
    Shichijō, 630-8053, Japan
  • Tokyo Shinagawa Hospital
    Shinagawa-ku, 140-8522, Japan
  • National Center for Global Health and Medicine
    Shinjuku, 162-8655, Japan
  • Keio University Hospital
    Shinjuku-ku, 160-8582, Japan
  • Nagano Prefectural Shinshu Medical Center
    Suzaka, 386-8610, Japan
  • National Hospital Organization Tokyo Medical Center
    Tokyo, 152-8902, Japan
  • National Hospital Organization Tokyo National Hospital
    Tokyo, 204-8585, Japan
  • National Hospital Organization Osaka Toneyama Medical Center
    Toyonaka-shi, 560-8552, Japan
  • Toyota Kosei Hospital
    Toyota, 470-0396, Japan
  • Toyota Memorial Hospital
    Toyota-shi, 471-8513, Japan
  • National Hospital Organization Ehime Medical Center
    Tōon, 791-0281, Japan
  • JRC Wakayama Medical Center
    Wakayama, 640 8558, Japan
  • Shimonoseki City Hospital
    Yamaguchi, 750-0041, Japan
  • Kanagawa Cardiovascular And Respiratory Center
    Yokohama, 236-0051, Japan
  • Chonnam National University Hospital
    Gwangju, 61469, South Korea
  • The Catholic University of Korea, Incheon St. Mary's Hospital
    Incheon, 403-720, South Korea
  • Asan Medical Center
    Seoul, 05505, South Korea
  • Samsung Medical Center
    Seoul, 135-230, South Korea
  • Kaohsiung Medical University Chung Ho Memorial Hospital
    Kaohsiung City, 80756, Taiwan
  • Taichung Veterans General Hospital
    Taichung, 40705, Taiwan
  • National Taiwan University Hospital
    Taipei, 10002, Taiwan
  • Taipei Veterans General Hospital
    Taipei, 112, Taiwan
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Data sharing details ↗ · www.janssen.com

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04630145
Lead sponsor
Janssen Pharmaceutical K.K.
Responsible party
Sponsor
First posted
Nov 16, 2020
Start date
Jan 8, 2021
Primary completion
Nov 6, 2024
Completion
Nov 14, 2025
Results posted
Apr 15, 2026
Last update
Apr 15, 2026

Study contacts

Janssen Pharmaceutical K.K., Japan clinical Trials
study director · Janssen Pharmaceutical K.K.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Bedaquiline

Other studies from this sponsor

Janssen Pharmaceutical K.K. →

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