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 With Pulmonary MDR-TB

Study Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less than \[\<\] 18 years of age) diagnosed with confirmed or probable pulmonary multidrug resistant tuberculosis (MDR-TB), in combination With a Background Regimen (BR) of MDR-TB Medications.

Conditions

Tuberculosis, Multidrug-Resistant

Interventions / Drugs

Bedaquiline (TMC207)Background Regimen (BR)

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment60 participants

Primary Completion—

Lead SponsorJanssen Research & Development, LLC

Data Retrieved2026-04-11 02:55:31.550316+00:00

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