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

Last updated: May 22, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Hiv

Lung Disease

Treatment

Background Regimen (BR)

Bedaquiline (TMC207)

Clinical Study ID

NCT02354014
CR106371
TMC207-TIDP59-C211
2014-003372-23
  • Ages < 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be a boy or girl, aged from birth (0 months) to less than (<) 18years at screening. Participants in Cohort 4 who are <6 months of age must begreater than or equal to (>=) 37 weeks gestation at baseline

  • Participant must weigh >3 kilogram (kg) at entry and be within the 5th and 95thpercentiles (inclusive) for the participant's age, based on the World HealthOrganization (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 localstandard of care

  • For Cohorts 1 and 2 only: Heterosexually active girls may participate if they are ofnon-childbearing potential, or if they are using effective birth control methods andare willing to continue practicing birth control methods throughout MultidrugResistant Tuberculosis (MDR-TB) treatment and for 6 months after stopping TMC207treatment, or if they are non-heterosexually active or willing to practice sexualabstinence throughout MDR-TB treatment

  • For Cohorts 1 and 2 only: Boys who engage in sexual activity that could lead topregnancy of the female partner must use at minimum a male condom throughout MDR-TBtreatment 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-extensivelydrug-resistant TB (pre- extensively drug resistant [XDR]-TB) or XDR-TB infection,based on the case definitions of pediatric pulmonary and non-severe extrapulmonaryTB as described in the International (WHO) guidelines and in accordance with thelocal standard of care

  • Participants must be starting the initial MDR-TB treatment at baseline or havestarted an MDR-TB treatment within 12 weeks of baseline and are willing to modify itif necessary to an acceptable MDR-TB regimen for use with TMC207

  • Participant must be willing to permanently discontinue RMP from at least 7 daysbefore the baseline visit

Exclusion

Exclusion Criteria:

  • Participant has a clinically significant active medical condition or the presence ofany concomitant severe illness or rapidly deteriorating health condition, includingimmune deficiency (except HIV infection), which in the opinion of the investigatorwould prevent appropriate participation in the study, or that would makeimplementation of the protocol or interpretation of the study results difficult, orotherwise make the subject a poor candidate for a clinical study

  • Participant is a girl who is pregnant, or breast-feeding, or planning to becomepregnant while enrolled in this study or within 6 months after stopping TMC207treatment

  • Participant tested positive for Human Immunodeficiency Virus (HIV) for the firsttime at screening. In addition, participants aged <2 years and participants who arebeing breastfed or were breastfed within the last 8 weeks before screening will beexcluded 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 significantairway compression); Pleural effusion or pleural fibrotic lesions

  • Participant has a significant cardiac arrhythmia that requires medication or ahistory 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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Background Regimen (BR)
Phase: 2
Study Start date:
May 03, 2016
Estimated Completion Date:
February 11, 2027

Study Description

This is an open-label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) and Phase 2 study. The study will consist of a screening phase, a 24-week open-label treatment phase during which all participants will receive bedaquiline (TMC207) in combination with a BR of MDR-TB medications, and a 96-week follow-up phase. Upon completion of the 24-week treatment with bedaquiline, all participants will continue to receive their BR under the care of the investigator. The total study duration will be 120 weeks for each participant. There will be 4 age based cohorts in this study. Cohort 1: greater than or equal to (>=) 12 to less than (<) 18 years of age; Cohort 2: >=5 to <12 years of age; Cohort 3: >=2 to <5 years of age; Cohort 4: 0 months to <2 years of age. Participants in Cohorts 1 and 2 will be enrolled concurrently followed by sequential enrollment of Cohorts 3 and 4. An internal safety monitoring group will review safety and pharmacokinetic data from each cohort to determine subsequent cohort enrollment and dose. Participants' safety will be monitored throughout the study.

Connect with a study center

  • B. J. Medical College & Civil Hospital

    Ahmedabad, 380 016
    India

    Site Not Available

  • National Institute for Research in Tuberculosis (NIRT)

    Chennai, 600 031
    India

    Site Not Available

  • National Institute of Tuberculosis and Respiratory Diseases (NITRD)

    New Delhi, 110 030
    India

    Site Not Available

  • Hospital Geral da Polana Caniço

    Maputo, 00000
    Mozambique

    Active - Recruiting

  • De La Salle Health Sciences Institute- DLSUMC

    Dasmarinas, 4114
    Philippines

    Active - Recruiting

  • Lung Center Of The Philippines

    Quezon City, 1100
    Philippines

    Completed

  • First Moscow State Medical University n.a. I.M. Sechenov

    Moscow, 119991
    Russian Federation

    Completed

  • THINK: Tuberculosis & HIV Investigative Network

    Durban, 4001
    South Africa

    Active - Recruiting

  • Sizwe Tropical Diseases Hospital

    Johannesburg, 2131
    South Africa

    Active - Recruiting

  • Wits Health Consortium

    Port Elizabeth, 6200
    South Africa

    Active - Recruiting

  • Desmond Tutu TB Centre

    Stellenboch, 7600
    South Africa

    Active - Recruiting

  • Makerere University Lung Institute

    Kampala,
    Uganda

    Terminated

  • State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

    Kiev, 3038
    Ukraine

    Completed

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.