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

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 3, 2016

Primary Completion Date

February 11, 2027

Study Completion Date

February 11, 2027

Conditions
Multidrug-Resistant Tuberculosis
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.

Trial Locations (11)

1100

COMPLETED

Lung Center Of The Philippines, Quezon City

2131

RECRUITING

Sizwe Tropical Diseases Hospital, Johannesburg

3038

COMPLETED

State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine, Kiev

4001

COMPLETED

THINK: Tuberculosis & HIV Investigative Network, Durban

4114

RECRUITING

De La Salle Health Sciences Institute- DLSUMC, Dasmariñas

6200

RECRUITING

Wits Health Consortium, Port Elizabeth

7600

RECRUITING

Desmond Tutu TB Centre, Stellenboch

119991

COMPLETED

First Moscow State Medical University n.a. I.M. Sechenov, Moscow

00000

RECRUITING

Hospital Geral da Polana Caniço, Maputo

000

RECRUITING

Silang Specialists Medical Center, San Vincent Silang

Unknown

TERMINATED

Makerere University Lung Institute, Kampala

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02354014 - 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 | Biotech Hunter | Biotech Hunter