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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/Adolescents With Pulmonary MDR-TB
Sponsor: Janssen Research & Development, LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
0 Months - 18 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2016-05-03
Completion Date
2028-11-02
Last Updated
2026-03-06
Healthy Volunteers
No
Conditions
Interventions
Bedaquiline (TMC207)
Bedaquiline (TMC207) oral tablet adult formulation (containing 100 mg bedaquiline (TMC207) per tablet) administered as 400 milligram (mg), once daily, for the first 2 weeks, followed by bedaquiline 200 mg 3 times per week with intakes at least 2 days (48 hours) apart for 22 weeks in cohort 1. Cohort 2, 3 and 4 will receive an age appropriate oral tablet formulation containing 20mg bedaquiline . Bedaquiline tablet administered orally as 200 mg, once daily, for the first 2 weeks, followed by bedaquiline 100 mg 3 times per week with intakes at least 2 days (48 hours) apart for 22 weeks in cohort 2. In Cohort 3, dose of bedaquiline 8 mg/kg qd for the first 2 weeks, followed by bedaquiline 4 mg/kg times weekly (TIW) with intakes at least 2 days (48 hours) apart for 22 weeks will be administered. In cohort 4, bedaquiline (TMC207) qd for the first 2 weeks, followed by bedaquiline TIW with intakes at least 2 days (48 hours) apart for 22 weeks.
Background Regimen (BR)
Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) medications will be dosed according to World Health Organization (WHO) guidelines, National Tuberculosis Program (NTP) guidelines and current standard of care at the site.
Locations (11)
Hospital Geral da Polana Caniço
Maputo, Mozambique
De La Salle Health Sciences Institute- DLSUMC
Dasmariñas, Philippines
Lung Center Of The Philippines
Quezon City, Philippines
Silang Specialists Medical Center
San Vincent Silang, Philippines
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, Russia
THINK: Tuberculosis & HIV Investigative Network
Durban, South Africa
Sizwe Tropical Diseases Hospital
Johannesburg, South Africa
Wits Health Consortium
Port Elizabeth, South Africa
Desmond Tutu TB Centre
Stellenboch, South Africa
Makerere University Lung Institute
Kampala, Uganda
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kiev, Ukraine