A Phase III Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Efficacy and Safety of TMC207 in Subjects With Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB)

Trial Profile

A Phase III Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Efficacy and Safety of TMC207 in Subjects With Sputum Smear-positive Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB)

Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2015

At a glance

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

    • 06 Feb 2014 According to the ClinicalTrials.gov record, Status changed from recruiting to withdrawn prior to recruitment.
    • 19 Dec 2013 Planned End Date changed from 1 Oct 2020 to 1 Nov 2022 as reported by ClinicalTrials.gov.
    • 11 Apr 2013 Planned end date changed from 1 Apr 2018 to 1 Oct 2020 as reported by ClinicalTrials.gov.
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