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

Phase 1

Active, not recruiting

• Conditions: Multi-drug resistant tuberculosis; MedDRA version: 19.0Level: PTClassification code 10044755Term: TuberculosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-003372-23-Outside-EU/EEA
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-28
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participant must be a boy or girl, aged from birth (0 months) to less than (<) 18 years at screening. Infants must be greater than or equal to (>=) 37 weeks gestation at baseline - Participant must weigh >4 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
- 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
- Participants must be starting the initial MDR-TB regimen at baseline or have started an MDR-TB regimen within 8 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, 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 (or the mother if the potential subject is a child aged <6 months) has a test positive for Human Immunodeficiency Virus (HIV) at screening or within 1 month before screening
- Participant has known or presumed complicated or severe extrapulmonary manifestations of TB, including TB meningitis. Participants with adenopathy or adenitis are allowed to enter the study
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified