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: 05 Jul 2023
Price :
$35
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At a glance
- Drugs Bedaquiline (Primary) ; Levofloxacin; Pyrazinamide
- Indications Pulmonary tuberculosis
- Focus Adverse reactions; Pharmacokinetics; Registrational
- Sponsors Janssen Research & Development
- 28 Jun 2023 Planned End Date changed from 13 Jul 2025 to 1 Feb 2027.
- 28 Jun 2023 Planned primary completion date changed from 21 Feb 2025 to 1 Feb 2025.
- 13 Apr 2021 Planned End Date changed from 1 Jul 2025 to 13 Jul 2025.