Study Phase 2

A Phase II, Open-label Trial With TMC207 as Part of a Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Subjects With Sputum Smear-positive Pulmonary Infection With MDR-TB

Trial Information

Generic NameBedaquiline/TMC207Product NameSIRTURO®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment241% Female36%% White11%
Product ClassAntimycobacterial AgentsSponsor Protocol NumberCR012352, TMC207-TiDP13-C209, 2008-008444-25Data PartnerJohnson & JohnsonCondition StudiedTuberculosisMean/Median Age (Years)34

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available

Approved Data Requests Associated with this Trial


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