Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)Phase 2/3NCT04630145

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 study testing Bedaquiline, Clarithromycin and Ethambutol in people with Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD), run by Janssen Pharmaceutical K.K. at 55 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 20 to 79 years
Conditions the study is for: Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
What is being tested?: Bedaquiline, Clarithromycin and Ethambutol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 129 participants
Where: 55 sitesin 3 countries
Study dates: 8 Jan 2021to 14 Nov 2025
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

55 sites in 3 countries.

Country

City, postcode or hospital

55 sites in 3 countries

Japan47 sites

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

Other trials in Japan

South Korea4 sites

Chonnam National University Hospital
Gwangju, 61469
The Catholic University of Korea, Incheon St. Mary's Hospital
Incheon, 403-720
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 135-230

Other trials in South Korea

Taiwan4 sites

Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 80756
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 112

Other trials in Taiwan

About this study

Official title: 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)

Conditions: Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
Being tested: Bedaquiline, Clarithromycin, Ethambutol, Rifampicin, Rifabutin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BedaquilineDrug
Participants will receive BDQ tablets only/
ClarithromycinDrug
Participants will receive CAM 400 or 500 mg twice a day.
EthambutolDrug
Participants will receive 500 to 750 mg daily (maximum daily dose of 1.0 gram [g]) or 15 mg/kg once a day.
RifampicinDrug
Participants will receive daily dose is 450 mg (maximum 600 mg) RFP capsule once a day.
RifabutinDrug
Participants will receive daily dose of RBT 300 mg or 150 mg capsules once a day.

Study groups in NCT04630145
Study group	Role	What they receive
Group A: Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)	Experimental	Participants will receive BDQ 400 milligrams (mg) (4100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2100mg 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. Receives: Drug: Bedaquiline; Drug: Clarithromycin; Drug: Ethambutol
Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB	Active comparator	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. Receives: Drug: Clarithromycin; Drug: Ethambutol; Drug: Rifampicin; Drug: Rifabutin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At Week 24

Secondary outcomes (24)

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.
Measured: At week 24
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.
Measured: Baseline (Day 1), Week 24
Percentage of Participants With Sputum Culture Conversion in MGIT at Week 48
Measured: At Week 48
Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 48
Measured: At Week 48
Percentage of Participants With Sputum Culture Negativity in MGIT
Measured: From Week 2 to Week 60
Percentage of Participants With Sputum Culture Negativity in 7H10 or 7H11 Agar Media
Measured: From Week 2 to Week 60
Time to Sputum Culture Conversion in MGIT up to Week 48
Measured: From baseline (Day 1) up to Week 48
Time to Positivity in MGIT up to Week 48
Measured: From baseline (Day 1) up to Week 48
Change From Baseline in Patient-Reported Health Status on Total Score of SGRQ at Weeks 48 and 60
Measured: Baseline (Day 1), Week 48 and Week 60
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.
Measured: Baseline (Day 1), Week 24
Change From Baseline in Lung Function Parameters at Weeks 48 and 60
Measured: Baseline (Day 1), Week 48 and Week 60
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.
Measured: Baseline (Day 1) up to Week 24
Percentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 48 and Week 60
Measured: Baseline (Day 1), Week 48 and Week 60
Percentage of Participants With Sputum Culture Conversion in MGIT at Week 60
Measured: At Week 60
Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 60
Measured: At Week 60
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Laboratory Tests
Measured: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Measured: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Vital Signs
Measured: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Physical Examination
Measured: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Visual Examination
Measured: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Audiology
Measured: From Baseline (Day 1) up to Week 60
Minimum Plasma Concentration Between 0 Hour and the Dosing Interval (Tau) (Ctrough) of BDQ and Its Metabolite M2
Measured: Day 1, Weeks 2, 8, 12, 24 and Week 48
Minimum Plasma Concentration Between 0 Hour and the Dosing Interval (Tau) (Ctrough) of Clarithromycin and Its Metabolite 4-OH CAM
Measured: Day 1, Weeks 2, 8, 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 202114 Nov 2025

First posted16 Nov 2020
Study start8 Jan 2021
Primary completion6 Nov 2024
Study completion14 Nov 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04630145
Sponsor's protocol ID: CR108897
Other IDs: TMC207NTM3002
Status last verified: Mar 2026
First submitted: 12 Nov 2020
Last updated: 15 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT04630145
Acronym / sponsor ID: CR108897
Conditions: Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
Study start: 8 Jan 2021 (actual)
Primary completion: 6 Nov 2024 (actual)
Study completion: 14 Nov 2025 (actual)
First posted: 16 Nov 2020 (actual)
Results: Posted 15 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A: Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)	Experimental	Drug: Bedaquiline, Drug: Clarithromycin, Drug: EthambutolParticipants will receive BDQ 400 milligrams (mg) (4100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2100mg 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.
Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB	Active comparator	Drug: Clarithromycin, Drug: Ethambutol, Drug: Rifampicin, Drug: RifabutinParticipants 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.

Who may qualify

Ages: 20 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BedaquilineParticipants will receive BDQ tablets only/	Drug	Group A: Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)
ClarithromycinParticipants will receive CAM 400 or 500 mg twice a day.	Drug	Group A: Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB), Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB
EthambutolParticipants will receive 500 to 750 mg daily (maximum daily dose of 1.0 gram [g]) or 15 mg/kg once a day.	Drug	Group A: Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB), Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB
RifampicinParticipants will receive daily dose is 450 mg (maximum 600 mg) RFP capsule once a day.	Drug	Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB
RifabutinParticipants will receive daily dose of RBT 300 mg or 150 mg capsules once a day.	Drug	Group B: Rifampicin (RFP) or Rifabutin (RBT) + CAM + EB

Primary outcome

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

24 secondary outcomes

Number of Participants With Sputum Culture Conversion in 7H11 Agar Media at Week 24
Time frame: At week 24
Change From Baseline in Patient Reported Health Status on Total Score of St. George's Respiratory Questionnaire (SGRQ) at Week 24
Time frame: Baseline (Day 1), Week 24
Percentage of Participants With Sputum Culture Conversion in MGIT at Week 48
Time frame: At Week 48
Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 48
Time frame: At Week 48
Percentage of Participants With Sputum Culture Negativity in MGIT
Time frame: From Week 2 to Week 60
Percentage of Participants With Sputum Culture Negativity in 7H10 or 7H11 Agar Media
Time frame: From Week 2 to Week 60
Time to Sputum Culture Conversion in MGIT up to Week 48
Time frame: From baseline (Day 1) up to Week 48
Time to Positivity in MGIT up to Week 48
Time frame: From baseline (Day 1) up to Week 48
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
Change From Baseline in Lung Function Parameters at Week 24
Time frame: Baseline (Day 1), Week 24
Change From Baseline in Lung Function Parameters at Weeks 48 and 60
Time frame: Baseline (Day 1), Week 48 and Week 60
Percentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 24
Time frame: Baseline (Day 1) up to Week 24
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
Percentage of Participants With Sputum Culture Conversion in MGIT at Week 60
Time frame: At Week 60
Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 60
Time frame: At Week 60
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Laboratory Tests
Time frame: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Time frame: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Physical Examination
Time frame: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Visual Examination
Time frame: From Baseline (Day 1) up to Week 60
Number of Participants With Clinically Significant Changes in Audiology
Time frame: From Baseline (Day 1) up to Week 60
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
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

Results and safety

Results posted to the registry on 15 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)	64	59
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)	65	63

Primary outcome: Number of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24

Time frame: At Week 24. Count of participants. Unit: Participants

Measure	Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB) n = 64	Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB) n = 65
Value	3	16

Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB) vs Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB): Risk Difference (RD): 19.7 (95% CI 8.3 to 31.2), p =0.002, Cochran-Mantel-Haenszel

Population analysed: Intent to treat (ITT) analysis set included all randomized participants who were randomly assigned to an intervention arm and who took at least 1 dose of study intervention.

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)	2 of 64 (3.1%)	29 of 64 (45.3%)	0 of 64
Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB)	4 of 65 (6.2%)	42 of 65 (64.6%)	0 of 65

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Janssen Pharmaceutical K.K.

55 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24 (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04630145.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.