6
Participants
Start Date
February 18, 2015
Primary Completion Date
November 8, 2018
Study Completion Date
November 8, 2018
TMC207 (bedaquiline)
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.
Background Regimen (BR)
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).
Kiyose
Sakai
Lead Sponsor
Janssen Pharmaceutical K.K.
INDUSTRY