An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)

PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

February 18, 2015

Primary Completion Date

November 8, 2018

Study Completion Date

November 8, 2018

Conditions
Tuberculosis, Multidrug-Resistant
Interventions
DRUG

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.

DRUG

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).

Trial Locations (2)

Unknown

Kiyose

Sakai

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY

NCT02365623 - An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB) | Biotech Hunter | Biotech Hunter