Condition: Tuberculosis, Multidrug-Resistant · Sponsor: Janssen Research & Development, LLC
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.
This description comes directly from the study's public registry record.
Study Contact · Participate-In-This-Study1@its.jnj.com
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| Hospital Geral da Polana Caniço | Maputo, Mozambique | Completed |
| De La Salle Health Sciences Institute- DLSUMC | Dasmariñas, Philippines | Recruiting |
| Lung Center Of The Philippines | Quezon City, Philippines | Completed |
| Silang Specialists Medical Center | San Vincent Silang, Philippines | Recruiting |
| First Moscow State Medical University n.a. I.M. Sechenov | Moscow, Russia | Completed |
| THINK: Tuberculosis & HIV Investigative Network | Durban, South Africa | Completed |
| Sizwe Tropical Diseases Hospital | Johannesburg, South Africa | Recruiting |
| Wits Health Consortium | Port Elizabeth, South Africa | Recruiting |
| Desmond Tutu TB Centre | Stellenboch, South Africa | Recruiting |
| Makerere University Lung Institute | Kampala, Uganda | Terminated |
| State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine | Kiev, Ukraine | Completed |
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Source record: clinicaltrials.gov/study/NCT02354014