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Clinical trial

A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of the Following: TMC207 Plus PA-824 Plus Pyrazinamide Plus Clofazimine, TMC207 Plus PA-824 Plus Pyrazinamide, TMC207 Plus PA-824 Plus Clofazimine Alone, TMC207 Plus Pyrazinamide Plus Clofazimine, Pyrazinamide Alone, and Clofazimine Alone; in Adult Patients With Newly Diagnosed, Smear-Positive Pulmonary Tuberculosis.

NCT01691534 is registered in ClinicalTrials.gov with Global Alliance for TB Drug Development as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of the Following: TMC207 Plus PA-824 Plus Pyrazinamide Plus Clofazimine, TMC207 Plus PA-824 Plus Pyrazinamide, TMC207 Plus PA-824 Plus Clofazimine Alone, TMC207 Plus Pyrazinamide Plus Clofazimine, Pyrazinamide Alone, and Clofazimine Alone; in Adult Patients With Newly Diagnosed, Smear-Positive Pulmonary Tuberculosis.
Lead sponsor
Global Alliance for TB Drug Development
Phase
Phase 2
Overall status
Completed
Start date
October 31, 2012
Completion date
May 31, 2013
Enrollment
105 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

pulmonary tuberculosis