NCT00449644View on ClinicalTrials.gov

TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).

PHASE2CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

March 31, 2010

Study Completion Date

October 31, 2012

Conditions
Tuberculosis
Interventions
DRUG

TMC207

TMC207 400mg (4 tablets) once daily for 14 days, 200mg (2 tablets) three times a week for 6 or 22 weeks.

DRUG

Placebo

Placebo 4 tablets once daily for 14 days, 2 tablets three times a week for 6 or 22 weeks.

DRUG

Background regimen (BR) for MDR-TB (multi-drug resistant tuberculosis)

Background Regimen (BR) of antibacterial drugs used in the treatment of TB according to national TB program and selected at the baseline visit as speciified in the protocol for up to 96 weeks.

Trial Locations (16)

Unknown

Rio de Janeiro

Chennai

New Delhi

Stopinu Region

Lima

Quezon City

Moscow

Bethelsdorp

Cape Town

Durban

George

Klerksdorp

Sandringham

Chiang Mai

Nakhon

Nonthaburi

All Listed Sponsors
lead

Janssen Infectious Diseases BVBA

INDUSTRY

NCT00449644 - TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB). | Biotech Hunter | Biotech Hunter