A Phase II, Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Anti-Bacterial Activity, Safety, and Tolerability of TMC207 in Subjects With Newly Diagnosed Sputum Smear-Positive Pulmonary Infection With Multi-Drug Resistant Mycobacterium Tuberculosis (MDR-TB).

Trial Profile

A Phase II, Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Anti-Bacterial Activity, Safety, and Tolerability of TMC207 in Subjects With Newly Diagnosed Sputum Smear-Positive Pulmonary Infection With Multi-Drug Resistant Mycobacterium Tuberculosis (MDR-TB).

Completed
Phase of Trial: Phase II

Latest Information Update: 28 Dec 2016

At a glance

  • Drugs Bedaquiline (Primary)
  • Indications Pulmonary tuberculosis
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Most Recent Events

    • 28 Dec 2016 Results assessing the prevalence of Rv0678 RAVs in clinical isolates from this and another phase II study (profile 700045709) published in the Journal of Antimicrobial Chemotherapy.
    • 31 Dec 2012 The US FDA granted accelerated approval of bedaquiline based on data from TMC207-C208 Study 1 and Study 2, according to a Janssen Therapeutics media release.
    • 31 Aug 2012 Data from this trial will be used in support of a filing with the European Medicines Agency according to a Janssen-Cilag media release.
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