Study Phase 2

An Open-label Study to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of TMC207 in Treatment-naive Subjects With Sputum Smear Positive Pulmonary Tuberculosis.

Trial Information

Generic NameBedaquiline/TMC207Product NameSIRTURO®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment75% FemaleN/A% WhiteN/A
Product ClassAntimycobacterial AgentsSponsor Protocol NumberTMC207-C202Data PartnerCondition StudiedTuberculosisMean/Median Age (Years)N/A

Supporting Documentation

  • Collected Datasets Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.