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| ID | Type | Description | Link |
|---|---|---|---|
| TMC207TBC2001 | Other Identifier | Janssen Pharmaceutical K.K. |
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The purpose of this study is to explore safety and efficacy of TMC207 administered as part of a multi-drug regimen for 24 to 48-week treatment in Japanese participants with pulmonary multi-drug resistant tuberculosis (MDR-TB), and to evaluate pharmacokinetics (PK) of TMC207 and its primary metabolite M2.
This is an open-label (everyone know the study intervention), single-arm, multicenter trial to explore safety, efficacy and PK of TMC207 in Japanese participants with pulmonary MDR-TB. The participants will receive TMC207 for 24 weeks in combination with individualized BR drugs selected by the Investigator on Day -1. Participants will primarily be assessed for sputum culture conversion at Week 24. Safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMC207 (bedaquiline) + Background Regimen (BR) | Experimental | Participants will receive TMC207 (bedaquiline) 400 milligram (mg) as 4*100 mg tablets once daily 2 weeks (14 days). From Week 3, participants will receive 200 mg (2 tablets) TMC207 (bedaquiline) 3 times a week up to Week 24 along with background regimen (BR). Based on the discussion with the Pharmaceuticals and Medical Devices Agency (PMDA), the extension of 24-week TMC207 treatment with BR drugs may occur up to Week 48, under certain circumstances, such that many BR drugs which are susceptible at the beginning of the Treatment Phase show resistance during the Treatment Phase. After TMC207 is stopped, the BR will be continued up to 78 weeks after conversion or 102 weeks after day 1 (what happens first). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC207 (bedaquiline) | Drug | TMC207 (bedaquiline): Participants will receive TMC207 (bedaquiline) 400 milligram (mg) as 4*100 mg tablets once daily 2 weeks (14 days) followed by 200 mg (2 tablets) 3 times a week up to Week 24 along with background regimen (BR). Based on the discussion with the Pharmaceuticals and Medical Devices Agency (PMDA), the extension of 24-week TMC207 treatment with BR drugs may occur up to Week 48, under certain circumstances, such that many BR drugs which are susceptible at the beginning of the Treatment Phase show resistance during the Treatment Phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sputum Culture Conversion | Sputum culture conversion is defined as 2 consecutive negative cultures from sputa collected at least 25 days apart. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Multidrug resistant (MDRTB) Outcome | Outcome is defined as, Cured: Participants who completed the study and has been consistently culture-negative (at least 5 consecutive negative cultures) for at least 48 weeks. If only 1 positive culture is reported in that time, participant may still be considered cured, provided that this positive culture is followed by a minimum of 3 consecutive negative cultures. Treatment failure: Participants who completed the study and was not cured. Death: Participants who died during study. Participants reported as dead during survival follow-up before or within Week 126 window were included in this category. Participants reported as dead during after Week 126 window are not included in this category as event occurred after planned duration (126 weeks) of study. Transfer out/Default: Participants who discontinued from study for any reason. Treatment completed: Participants who completed the study but did not meet definition for cure or treatment failure due to lack of bacteriologic results. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K. Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kiyose | Japan | |||||
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| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| C493870 | bedaquiline |
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| Background Regimen (BR) | Drug | Participants will receive anti-bacterial tuberculosis drugs (pyrazinamide [PZA], ethambutol [EB, EMB], streptomycin [SM], kanamycin [KM, KAN], enviomycin [EVM], ethionamide [TH], cycloserine [CS], para-aminosalicylic acid [PAS], amikacin [AMK], levofloxacin [LVFX] and other fluoroquinolone. Other drugs are used less commonly, such as amoxicillin-clavulanate, linezolid and clofazimine based on Investigator's decision twice a week from Day 1 up to 78 weeks after conversion or 102 weeks after day 1 (what happens first). |
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| Week 102 |
| Sakai |
| Japan |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |