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 Profile

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

Completed
Phase of Trial: Phase II

Latest Information Update: 25 Apr 2017

At a glance

  • Drugs Bedaquiline (Primary)
  • Indications Pulmonary tuberculosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Janssen Infectious Diseases BVBA
  • Most Recent Events

    • 25 Apr 2017 Results confirming exposure-response relationship with data from this trial presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases.
    • 28 Dec 2016 Results assessing the prevalence of Rv0678 RAVs in clinical isolates from this and another phase II study (profile 700023425) published in the Journal of Antimicrobial Chemotherapy.
    • 02 Dec 2015 Results published in the European Respiratory Journal
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