An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB)
Tuberculosis, Multidrug-Resistant
About this trial
This is an interventional treatment trial for Tuberculosis, Multidrug-Resistant focused on measuring Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB), TMC207, Bedaquiline
Eligibility Criteria
Inclusion Criteria:
- Must have confirmed pulmonary multi-drug resistant tuberculosis (MDR-TB) infection, which is defined as infection by a strain of M. tuberculosis resistant to both rifampicin and isoniazid (RFP and INH) by previous screening from a TB treatment
- Must have confirmed positive results for acid-fast bacilli (AFB) on direct smear examination of expectorated sputum specimen (more than [>] 1+ smear-positive) during the Screening Phase or sputum culture positive for M. tuberculosis within the preceding 3 months
- A women must not be of childbearing potential: postmenopausal or permanently sterilized or otherwise be incapable of pregnancy, or if childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods and a man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control
- Must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
- Has any concomitant severe illness or rapidly deteriorating health condition, including immune deficiency that would make implementation of the protocol or interpretation of the study results difficult or otherwise make the subject a poor candidate for a clinical study
- Has complicated or severe extra-pulmonary manifestations of TB, including central nervous system infection
- Participants with significant cardiac arrhythmia requiring medication
- Participants with the abnormal electrocardiogram (ECG) parameters as defined in protocol
- Has human immuno deficiency virus (HIV) antibody positive during the Screening Phase
Sites / Locations
Arms of the Study
Arm 1
Experimental
TMC207 (bedaquiline) + Background Regimen (BR)
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).