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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

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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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 30 Apr 2025

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At a glance

  • Drugs Bedaquiline (Primary) ; Levofloxacin; Pyrazinamide
  • Indications Pulmonary tuberculosis
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Sponsors Janssen Research & Development

Most Recent Events

  • 03 Feb 2025 Planned primary completion date changed from 21 Feb 2025 to 11 Feb 2027.
  • 09 Dec 2024 Planned End Date changed from 1 Feb 2027 to 11 Feb 2027.
  • 09 Dec 2024 Planned primary completion date changed from 1 Feb 2025 to 21 Feb 2025.

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