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Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/A...

Update Il y a 4 ans
Reference: EUCTR2014-003372-23

Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents Pulmonary MDR-TB

Woman and Man

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Extract

- to evaluate the safety and tolerability of TMC207 over a 24-week treatment period in each age cohort. - to evaluate the pharmacokinetics of TMC207 over a 24-week treatment period in the different age cohorts and to provide guidance on dose selection for each of the age cohorts evaluated in this study.

Inclusion criteria

  • Multi-drug resistant tuberculosis