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 AreaAnti-Infectives for Systemic UseProduct ClassAntimycobacterialsPharmacological SubgroupDrugs for Treatment of TuberculosisChemical SubgroupOther Drugs for Treatment of TuberculosisCondition StudiedTuberculosis
Sponsor Protocol NumberTMC207-C202Enrollment75Data PartnerJohnson & Johnson% Female40.0%Mean/Median Age (Years)34.0% White43.0%

Supporting Documentation

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

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