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RECRUITING
NCT02354014
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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