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
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
- 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.