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 With Pulmonary MDR-TB

Last updated: May 7, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Lung Disease

Hiv

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 at screening,gestational age at birth had to be greater than or equal to (>=) 37 weeks

  • Participant must weigh >3 kilogram (kg) at baseline 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/length may be used instead of BMI for age according tothe local standard of care. Per WHO guidance, for participants aged < 2 years inCohort 4, length will be used to calculate the BMI instead of height

  • 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 Day 1 or have startedan MDR-TB treatment within 12 weeks of Day 1 and are willing to modify it ifnecessary 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

  • Participant or legally acceptable representative must consent/assent to humanImmunodeficiency virus (HIV) testing of the participant. The mother must alsoconsent to testing of her own HIV status, if the potential participant is a childaged <2 years, or if the participant is >= 2 years old and being breastfed or wasbreastfed within the last 8 weeks before screening, unless the mother had HIV testperformed within 1 month prior to screening and documentation of HIV status can beprovided. When documented HIV-positive status is available prior to screening forparticipants in Cohort 4 or their mother, HIV testing for the participant and motheris not required

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 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 riskfactors for Torsade de Pointes, example heart failure, hypokalemia, known personalor 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:
November 02, 2028

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

  • Hospital Geral da Polana Caniço

    Maputo 1040652, 00000
    Mozambique

    Site Not Available

  • De La Salle Health Sciences Institute- DLSUMC

    Dasmarinas, 4114
    Philippines

    Site Not Available

  • De La Salle Health Sciences Institute- DLSUMC

    Dasmariñas, 4114
    Philippines

    Active - Recruiting

  • De La Salle Health Sciences Institute- DLSUMC

    Dasmariñas 1715430, 4114
    Philippines

    Site Not Available

  • Lung Center Of The Philippines

    Quezon City, 1100
    Philippines

    Completed

  • Lung Center Of The Philippines

    Quezon City 1692192, 1100
    Philippines

    Site Not Available

  • Silang Specialists Medical Center

    San Vincent Silang, 000
    Philippines

    Active - Recruiting

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

    Moscow, 119991
    Russia

    Completed

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

    Moscow 524901, 119991
    Russia

    Site Not Available

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

    Moscow, 119991
    Russian Federation

    Site Not Available

  • THINK: Tuberculosis & HIV Investigative Network

    Durban, 4001
    South Africa

    Completed

  • THINK: Tuberculosis & HIV Investigative Network

    Durban 1007311, 4001
    South Africa

    Site Not Available

  • Sizwe Tropical Diseases Hospital

    Johannesburg, 2131
    South Africa

    Active - Recruiting

  • Sizwe Tropical Diseases Hospital

    Johannesburg 993800, 2131
    South Africa

    Site Not Available

  • Wits Health Consortium

    Port Elizabeth, 6200
    South Africa

    Active - Recruiting

  • Wits Health Consortium

    Port Elizabeth 964420, 6200
    South Africa

    Site Not Available

  • Desmond Tutu TB Centre

    Stellenboch, 7600
    South Africa

    Active - Recruiting

  • Makerere University Lung Institute

    Kampala,
    Uganda

    Terminated

  • Makerere University Lung Institute

    Kampala 232422,
    Uganda

    Site Not Available

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

    Kiev, 3038
    Ukraine

    Completed

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

    Kiev 703448, 3038
    Ukraine

    Site Not Available

Map preview placeholder

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.