A Phase 2, Open-label, Multicenter, Single-arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Anti-mycobacterial Activity of TMC207 in Combination With a Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for the Treatment of Children and Adolescents 0 Months to <18 Years of Age Who Have Confirmed or Probable Pulmonary MDR-TB

Trial Profile

A Phase 2, Open-label, Multicenter, Single-arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Anti-mycobacterial Activity of TMC207 in Combination With a Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for the Treatment of Children and Adolescents 0 Months to <18 Years of Age Who Have Confirmed or Probable Pulmonary MDR-TB

Recruiting
Phase of Trial: Phase II

Latest Information Update: 25 Jul 2017

At a glance

  • Drugs Bedaquiline (Primary)
  • Indications Pulmonary tuberculosis
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 18 Jul 2017 Planned End Date changed from 1 Dec 2022 to 26 Feb 2025.
    • 31 May 2016 Status changed from not yet recruiting to recruiting.
    • 31 May 2016 Evaluation at week 2 and week 12 is added in the time frame of the primary end points.
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