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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Jan 29, 2015

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called bedaquiline (TMC207) when used alongside other drugs to treat children and teenagers with multidrug-resistant tuberculosis (MDR-TB). The goal is to find out how safe the medication is, how well it works against the bacteria that cause TB, and how the body processes it. Children and adolescents from birth up to 17 years old who weigh more than 3 kilograms and have a confirmed or suspected case of pulmonary MDR-TB may be eligible to participate.

Participants can expect to receive regular health check-ups and monitoring throughout the study to ensure their safety and well-being. Parents should know that the trial is open to both boys and girls, but there are specific rules about birth control for those who are sexually active to prevent pregnancy during the study. Overall, this trial aims to improve treatment options for young patients battling MDR-TB, which is a challenging and serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant must be a boy or girl, aged from birth (0 months) to less than (\<) 18 years at screening. Participants in Cohort 4 who are \<6 months of age must be greater than or equal to (\>=) 37 weeks gestation at baseline
• • Participant must weigh \>3 kilogram (kg) at entry and be within the 5th and 95th percentiles (inclusive) for the participant's age, based on the World Health Organization (WHO) child growth standards; Body Mass Index (BMI) for age. In Cohorts 3 and 4, weight for height may be used instead of BMI for age according to the local standard of care
• • For Cohorts 1 and 2 only: Heterosexually active girls may participate if they are of non-childbearing potential, or if they are using effective birth control methods and are willing to continue practicing birth control methods throughout Multidrug Resistant Tuberculosis (MDR-TB) treatment and for 6 months after stopping TMC207 treatment, or if they are non-heterosexually active or willing to practice sexual abstinence throughout MDR-TB treatment
• • For Cohorts 1 and 2 only: Boys who engage in sexual activity that could lead to pregnancy of the female partner must use at minimum a male condom throughout MDR-TB treatment and for 3 months after stopping TMC207 treatment
• • Participant must have confirmed or probable (clinically diagnosed or presumed) pulmonary and/or non-severe extrapulmonary MDR-TB, including pre-extensively drug-resistant TB (pre- extensively drug resistant \[XDR\]-TB) or XDR-TB infection, based on the case definitions of pediatric pulmonary and non-severe extrapulmonary TB as described in the International (WHO) guidelines and in accordance with the local standard of care
• • Participants must be starting the initial MDR-TB treatment at baseline or have started an MDR-TB treatment within 12 weeks of baseline and are willing to modify it if necessary to an acceptable MDR-TB regimen for use with TMC207
• • Participant must be willing to permanently discontinue RMP from at least 7 days before the baseline visit
• Exclusion Criteria:
• • Participant has a clinically significant active medical condition or the presence of any concomitant severe illness or rapidly deteriorating health condition, including immune deficiency (except HIV infection), which in the opinion of the investigator would prevent appropriate participation in the study, or that would make implementation of the protocol or interpretation of the study results difficult, or otherwise make the subject a poor candidate for a clinical study
• • Participant is a girl who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after stopping TMC207 treatment
• • Participant tested positive for Human Immunodeficiency Virus (HIV) for the first time at screening. In addition, participants aged \<2 years and participants who are being breastfed or were breastfed within the last 8 weeks before screening will be excluded if the mother has tested positive for HIV
• • Participant has known or presumed forms of extrapulmonary TB, other than: Lymphadenopathy (peripheral nodes or isolated mediastinal mass without significant airway compression); Pleural effusion or pleural fibrotic lesions
• • Participant has a significant cardiac arrhythmia that requires medication or a history of risk factors for Torsade de Pointes, example heart failure, hypokalemia, known personal or family history of Long QT Syndrome, and untreated hypothyroidism