EUCTR2014-003372-23-Outside-EU/EEAActive, not recruitingPhase 1
A Phase 2, Open-label, Multicenter, Single-arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Antimycobacterial Activity of TMC207 in Combination With a Background Regimen (BR) of Multidrug Resistant Tuberculosis(MDR-TB) Medications for the Treatment of Children and Adolescents 0 Months to <18 Years of Age Who Have Confirmed or Probable Pulmonary MDR-TB
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •- 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
Investigators
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