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| ID | Type | Description | Link |
|---|---|---|---|
| TMC207NTM3002 | Other Identifier | Janssen Research & Development, LLC |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB) | Experimental | 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bedaquiline | Drug | Participants will receive BDQ tablets only/ |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan clinical Trials | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka University Chikushi Hospital | Chikushino-shi | 818-8502 | Japan | |||
| St. Luke's International Hospital |
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
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Results are currently reported until the Week 24 cut-off. Results of remaining duration will be posted upon study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB) | Participants received rifamycin (either rifampicin [RFP] 450 milligrams [mg] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin [RBT] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram [g]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 8, 2022 | Mar 27, 2026 |
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| Clarithromycin | Drug | Participants will receive CAM 400 or 500 mg twice a day. |
|
| Ethambutol | Drug | Participants will receive 500 to 750 mg daily (maximum daily dose of 1.0 gram [g]) or 15 mg/kg once a day. |
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| Rifampicin | Drug | Participants will receive daily dose is 450 mg (maximum 600 mg) RFP capsule once a day. |
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| Rifabutin | Drug | Participants will receive daily dose of RBT 300 mg or 150 mg capsules once a day. |
|
| 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. |
| Baseline (Day 1), Week 24 |
| Percentage of Participants With Sputum Culture Conversion in MGIT at Week 48 | At Week 48 |
| Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 48 | At Week 48 |
| Percentage of Participants With Sputum Culture Negativity in MGIT | From Week 2 to Week 60 |
| Percentage of Participants With Sputum Culture Negativity in 7H10 or 7H11 Agar Media | From Week 2 to Week 60 |
| Time to Sputum Culture Conversion in MGIT up to Week 48 | From baseline (Day 1) up to Week 48 |
| Time to Positivity in MGIT up to Week 48 | 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 | 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. | Baseline (Day 1), Week 24 |
| Change From Baseline in Lung Function Parameters at Weeks 48 and 60 | 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. | 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 | Baseline (Day 1), Week 48 and Week 60 |
| Percentage of Participants With Sputum Culture Conversion in MGIT at Week 60 | At Week 60 |
| Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 60 | At Week 60 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From Baseline (Day 1) up to Week 60 |
| Number of Participants With Clinically Significant Changes in Laboratory Tests | From Baseline (Day 1) up to Week 60 |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | From Baseline (Day 1) up to Week 60 |
| Number of Participants With Clinically Significant Changes in Vital Signs | From Baseline (Day 1) up to Week 60 |
| Number of Participants With Clinically Significant Changes in Physical Examination | From Baseline (Day 1) up to Week 60 |
| Number of Participants With Clinically Significant Changes in Visual Examination | From Baseline (Day 1) up to Week 60 |
| Number of Participants With Clinically Significant Changes in Audiology | 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 | 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 | Day 1, Weeks 2, 8, 12 and 24 |
| 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 |
| FG001 | Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB) | Participants received BDQ 400 mg (4*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram [g]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB) | Participants received rifamycin (either rifampicin [RFP] 450 milligrams [mg] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin [RBT] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram [g]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60. |
| BG001 | Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB) | Participants received BDQ 400 mg (4*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram [g]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | At Week 24 |
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | At week 24 |
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| Secondary | 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. | 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. Here, N (overall number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on scale | Baseline (Day 1), Week 24 |
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| Secondary | Percentage of Participants With Sputum Culture Conversion in MGIT at Week 48 | Not Posted | Nov 2026 | At Week 48 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 48 | Not Posted | Nov 2026 | At Week 48 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sputum Culture Negativity in MGIT | Not Posted | Nov 2026 | From Week 2 to Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sputum Culture Negativity in 7H10 or 7H11 Agar Media | Not Posted | Nov 2026 | From Week 2 to Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Sputum Culture Conversion in MGIT up to Week 48 | Not Posted | Nov 2026 | From baseline (Day 1) up to Week 48 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Positivity in MGIT up to Week 48 | Not Posted | Nov 2026 | From baseline (Day 1) up to Week 48 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient-Reported Health Status on Total Score of SGRQ at Weeks 48 and 60 | Not Posted | Nov 2026 | Baseline (Day 1), Week 48 and Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. Here, N (overall number of participants analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies participants evaluated for specified categories. | Posted | Mean | Standard Deviation | milliliters | Baseline (Day 1), Week 24 |
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| Secondary | Change From Baseline in Lung Function Parameters at Weeks 48 and 60 | Not Posted | Nov 2026 | Baseline (Day 1), Week 48 and Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | percentage of participants | Baseline (Day 1) up to Week 24 |
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| Secondary | Percentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 48 and Week 60 | Not Posted | Nov 2026 | Baseline (Day 1), Week 48 and Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sputum Culture Conversion in MGIT at Week 60 | Not Posted | Nov 2026 | At Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 60 | Not Posted | Nov 2026 | At Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Not Posted | Nov 2026 | From Baseline (Day 1) up to Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Laboratory Tests | Not Posted | Nov 2026 | From Baseline (Day 1) up to Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) | Not Posted | Nov 2026 | From Baseline (Day 1) up to Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs | Not Posted | Nov 2026 | From Baseline (Day 1) up to Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Physical Examination | Not Posted | Nov 2026 | From Baseline (Day 1) up to Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Visual Examination | Not Posted | Nov 2026 | From Baseline (Day 1) up to Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Audiology | Not Posted | Nov 2026 | From Baseline (Day 1) up to Week 60 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimum Plasma Concentration Between 0 Hour and the Dosing Interval (Tau) (Ctrough) of BDQ and Its Metabolite M2 | Not Posted | Nov 2026 | Day 1, Weeks 2, 8, 12, 24 and Week 48 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimum Plasma Concentration Between 0 Hour and the Dosing Interval (Tau) (Ctrough) of Clarithromycin and Its Metabolite 4-OH CAM | Not Posted | Nov 2026 | Day 1, Weeks 2, 8, 12 and 24 | Participants |
All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24
Safety analysis set included all participants who received at least 1 dose of the study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB) | Participants received rifamycin (either rifampicin [RFP] 450 milligrams [mg] as capsule once daily or maximum daily dose of 600 mg orally, or rifabutin [RBT] 300 mg or 150 mg once daily orally) along with CAM 400 mg or 500 mg twice daily orally and EB 500-750 mg daily (maximum daily dose of 1.0 gram [g]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 60. | 0 | 64 | 2 | 64 | 29 | 64 |
| EG001 | Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB) | Participants received BDQ 400 mg (4*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram [g]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48. | 0 | 65 | 4 | 65 | 42 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Taste Disorder | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Head Mycobacteria | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2025 | Mar 27, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| C493870 | bedaquiline |
| D017291 | Clarithromycin |
| D004977 | Ethambutol |
| D012293 | Rifampin |
| D017828 | Rifabutin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| 60 to 69 years |
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| 70 years and over |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| SOUTH KOREA |
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| TAIWAN |
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Participants received BDQ 400 mg (4*100 mg tablets) once daily (qd) from Week 1-2 (loading phase), BDQ 200 mg (2*100 mg tablets) bi-weekly (biw) from Week 3 to 24 (maintenance phase) along with CAM 400 mg or 500 mg twice daily along with EB 500-750 mg daily (maximum daily dose of 1.0 gram [g]) or 15 milligrams per kilograms (mg/kg) once a day up to Week 48. |
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