Actively Recruiting
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
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
60
Participants Needed
11
Research Sites
652 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is a boy or girl aged from birth (0 months) to less than 18 years at screening
- Participant weighs more than 3 kilograms and is within the 5th to 95th percentiles for age based on WHO child growth standards
- Cohort 4 participants under 6 months must have a gestational age at birth of at least 37 weeks
- For Cohorts 1 and 2: heterosexually active girls must be of non-childbearing potential or use effective birth control during treatment and for 6 months after stopping TMC207, or be non-heterosexually active or abstinent during treatment
- For Cohorts 1 and 2: boys engaging in sexual activity that could lead to pregnancy must use condoms during treatment and for 3 months after stopping TMC207
- Participant has confirmed or probable pulmonary and/or non-severe extrapulmonary MDR-TB, including pre-XDR or XDR-TB, based on WHO and local guidelines
- Participant is starting MDR-TB treatment on Day 1 or started treatment within 12 weeks and agrees to modify it to an acceptable regimen for TMC207 use
- Participant agrees to permanently discontinue rifampicin (RMP) at least 7 days before baseline
- Participant or legal representative consents to HIV testing; for children under 2 or breastfed recently, the mother must also consent to HIV testing unless recent HIV status is documented
You will not qualify if you...
- Participant has a significant active medical condition or severe illness that may interfere with study participation or result interpretation, including immune deficiencies except HIV infection
- Female participants who are pregnant, breastfeeding, or planning pregnancy during the study or within 6 months after stopping TMC207
- Participant has known or presumed extrapulmonary TB other than lymphadenopathy or pleural effusion/fibrotic lesions
- Participant has significant cardiac arrhythmia requiring medication or risk factors for Torsade de Pointes such as heart failure, hypokalemia, personal or family history of Long QT Syndrome, or untreated hypothyroidism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Hospital Geral da Polana Caniço
Maputo, Mozambique, 00000
Actively Recruiting
2
De La Salle Health Sciences Institute- DLSUMC
Dasmariñas, Philippines, 4114
Actively Recruiting
3
Lung Center Of The Philippines
Quezon City, Philippines, 1100
Completed
4
Silang Specialists Medical Center
San Vincent Silang, Philippines, 000
Actively Recruiting
5
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, Russia, 119991
Completed
6
THINK: Tuberculosis & HIV Investigative Network
Durban, South Africa, 4001
Completed
7
Sizwe Tropical Diseases Hospital
Johannesburg, South Africa, 2131
Actively Recruiting
8
Wits Health Consortium
Port Elizabeth, South Africa, 6200
Actively Recruiting
9
Desmond Tutu TB Centre
Stellenboch, South Africa, 7600
Actively Recruiting
10
Makerere University Lung Institute
Kampala, Uganda
Terminated
11
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kiev, Ukraine, 3038
Completed
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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