临床试验/CTRI/2018/03/012637

CTRI/2018/03/012637Other2 期

A Phase 2, Open-label, Multicenter, Single-arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Anti-mycobacterial 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 less than 18 years of Age Who Have Confirmed or Probable Pulmonary MDR-TB

Janssen Research Development LLC3 个研究点分布在 1 个国家目标入组 60 人开始时间: 2019年1月31日最近更新: 2019年2月27日

试验速览

阶段: 2 期
状态: Other
发起方: Janssen Research Development LLC
入组人数: 60
试验地点: 3
主要终点: b)Maximum Plasma Concentration

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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 MDRTB Medications.

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Open Label

入排标准

年龄范围: 0.00 Month(s) 至 18.00 Year(s)（—）
性别: All

入选标准

•1.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 2.Participant must weigh more than 4 kilogram (kg) at entry and be within the 5th and 95th percentiles (inclusive) for the participantâ€™s age, based on the World Health Organization (WHO) child growth standards; Body Mass Index (BMI) for age 3.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 4.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 5.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 6.Participant must be willing to permanently discontinue RMP from at least 7 days before the baseline visit.

排除标准

•1.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 2.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 3.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 4.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 5.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 6.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.

结局指标

主要结局

b)Maximum Plasma Concentration

时间窗: a)120 weeks | b)Day 1,week 2,4,6,8,12,16,20,24 | c)Day 1,week 2,4,6,8,12,16,20,24 | d)Day 1, week 2, 4,6,8,12,16,20,24,28,32,40,48,60,72,84,96,108,120 | e)Day 1, week 2, 4,6,8,12,16,20,24,28,32,40,48,60,72,84,96,108,120 | f)Day 1, week 2, 4,6,8,12,16,20,24,28,32,40,48,60,72,84,96,108,120 | g)Pre-dose (time 0) at Day 1 up to 168 hour | h)Day 1, week 2, 4,6,8,12,16,20,24,28,32,40,48,60,72,84,96,108,120 | i) Day 1, week 2, 4,6,8,12,16,20,24,28,32,40,48,60,72,84,96,108,120

a)Number of Participants With Adverse Events or Serious Adverse Events

e)Area Under the Plasma Concentration-time Curve From the Time of Dose Administration up to X Hours

c)Time to Reach Maximum Plasma Concentration

h)Volume of Distribution

d)Minimum Plasma Concentration

f)Elimination Half-life

g)Area Under the Plasma Concentration-time Curve From the Time of Dose Administration up to 168 Hours

i) Apparent Clearance (CL)

次要结局

Percentage of Participants with Favorable Treatment outcome (Sustained Positive Clinical Cure)(Week 24, Week 120 (end of study))
Time to First Confirmed Sputum Culture Conversion or Other Microbiology Specimen Sample(Baseline (Day 1) up to Week 120)

研究者

发起方

Janssen Research Development LLC

申办方类型

Pharmaceutical industry-Global

研究点 (3)

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