Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination Wit
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 resis
| Condition(s) | Tuberculosis, Multidrug-Resistant |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Participant must be a boy or girl, aged from birth (0 months) to less than (\<) 18 years at screening. Participants in Cohort 4 who are \<6 months of age at screening, gestational age at birth had to be greater than or equal to (\>=) 37 weeks * Participant must weigh \>3 kilogram (kg) at baseline and be within the 5th and 95th percentiles (inclusive) for the participant's age, based on the World Health Organization (WHO) child growth standards; Body Mass Index (BMI) for age. In Cohorts 3 and 4, weight for height/length may be used instead of BMI for age according to the local standard of care. Per WHO guidance, for participants aged \< 2 years in Cohort 4, length will be used to calculate the BMI instead of height * For Cohorts 1 and 2 only: Heterosexually active girl |
| Ages | 0 Months to 18 Years |
| Sex | All |
| Lead sponsor | Janssen Research & Development, LLC |
| Locations | Maputo, Mozambique; Dasmariñas, Philippines; Quezon City, Philippines; San Vincent Silang, Philippines; Moscow, Russia; Durban, South Africa (+5 more sites) |
| Start date | 2016-05-03 |
| NCT ID | NCT02354014 |
| Official listing | https://clinicaltrials.gov/study/NCT02354014 |