A Phase 2 interventional study of Bedaquiline (TMC207) and Background Regimen (BR) in Tuberculosis, Multidrug-Resistant, sponsored by Janssen Research & Development, LLC. Suspended at 11 sites in 6 countries. Open to participants aged 0 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
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.
132 studies on the registry are indexed under Tuberculosis, Multidrug-Resistant; 25 are open to participants now.
This study's planned enrollment of 60 is below the median of 194 across 88 interventional studies indexed under Tuberculosis, Multidrug-Resistant.
Browse Tuberculosis, Multidrug-Resistant studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There will be 4 age-based cohorts. Participants will be enrolled concurrently in Cohorts 1 and 2 followed by sequential enrollment of Cohorts 3, 4. Cohort 1: \>= 12 to \< 18 years: bedaquiline (TMC207) tablet orally as 400 mg, once daily(qd),for first 2 weeks, followed by bedaquiline (TMC207), 200 mg 3 times per week (tiw) for 22 weeks; Cohort 2: \>=5 to \<12 years: bedaquiline (TMC207) tablet given orally as 200 mg, qd, for first 2 weeks, followed by bedaquiline (TMC207) 100 mg, tiw for 22 weeks. Cohort 3: \>=2 to \<5 years: bedaquiline (TMC207) 8 milligram per kilogram (mg/kg) qd for the first 2 weeks, followed by bedaquiline (TMC207) 4 mg/kg tiw for 22 weeks. Cohort 4: 0 months to \<2 years: bedaquiline (TMC207) doses will be selected as per weight band and age group. Bedaquiline (TMC207) will be given in combination with Background Regimen for Multidrug Resistant Tuberculosis (MDR-TB) according to WHO/national tuberculosis program (NTP) guidelines/current standard of care.
Drug: Bedaquiline (TMC207) · Drug: Background Regimen (BR)
Bedaquiline (TMC207) oral tablet adult formulation (containing 100 mg bedaquiline (TMC207) per tablet) administered as 400 milligram (mg), once daily, for the first 2 weeks, followed by bedaquiline 200 mg 3 times per week with intakes at least 2 days (48 hours) apart for 22 weeks in cohort 1. Cohort 2, 3 and 4 will receive an age appropriate oral tablet formulation containing 20mg bedaquiline . Bedaquiline tablet administered orally as 200 mg, once daily, for the first 2 weeks, followed by bedaquiline 100 mg 3 times per week with intakes at least 2 days (48 hours) apart for 22 weeks in cohort 2. In Cohort 3, dose of bedaquiline 8 mg/kg qd for the first 2 weeks, followed by bedaquiline 4 mg/kg times weekly (TIW) with intakes at least 2 days (48 hours) apart for 22 weeks will be administered. In cohort 4, bedaquiline (TMC207) qd for the first 2 weeks, followed by bedaquiline TIW with intakes at least 2 days (48 hours) apart for 22 weeks.
Also known as: Bedaquiline
Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) medications will be dosed according to World Health Organization (WHO) guidelines, National Tuberculosis Program (NTP) guidelines and current standard of care at the site.
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Cohort 1 to 3 = up to 120 Weeks and Cohort 4 = up to 88 Weeks
Maximum Plasma Concentration (Cmax)
The Cmax is the maximum plasma concentration.
Time frame: Week 2 and 12
Time to Reach Maximum Plasma Concentration (Tmax)
The Tmax is time to reach the maximum plasma concentration.
Time frame: Week 2 and 12
Minimum Plasma Concentration (Cmin)
The Cmin is the minimum plasma concentration.
Time frame: Week 2, 12 and 24
Area Under the Plasma Concentration-time Curve From the Time of Dose Administration up to X Hours (AUCtime-h)
AUCtime-h is the area under the plasma concentration-time curve from the time of dose administration up to X hours.
Time frame: Week 2, 12 and 24
Elimination Half-life (t1/2)
Elimination half-life (t \[1/2\]) is associated with the terminal slope (lambda \[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z). Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Time frame: For Cohorts 1 to 3: Day 1, Weeks 2, 4,6,8,12,16,20,24,28,32,40,48,60,72,84,96,108,120; For Cohort 4: Day 1, Weeks 2,12, 24, 32, 48, 88
Area Under the Plasma Concentration-time Curve From the Time of Dose Administration up to 168 Hours [AUC168h]
AUC168h is the area under the plasma concentration-time curve from the time of dose administration up to 168 Hours.
Time frame: Week 12 and 24
Volume of Distribution (Vd)
Volume of distribution is calculated as Dose divided by Lambda(z) multiplied by AUC(infinity). The AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time.
Time frame: For Cohorts 1 to 3: Day 1, Weeks 2, 4,6,8,12,16,20,24,28,32,40,48,60,72,84,96,108,120; For Cohort 4: Day 1, Weeks 2,12, 24, 32, 48, 88
Apparent Clearance (CL)
Apparent clearance is calculated as Dose/AUC (infinity). The AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time.
Time frame: For Cohorts 1 to 3: Day 1, Weeks 2, 4,6,8,12,16,20,24,28,32,40,48,60,72,84,96,108,120; For Cohort 4: Day 1, Weeks 2,12, 24, 32, 48, 88
Percentage of Participants with Favorable Treatment outcome (Sustained Clinical Cure)
Sustained Clinical Cure is defined as the percentage of participants with favorable treatment outcome at Week 24 and at study end.
Time frame: Week 24, Week 120 (for Cohorts 1 to 3) and Week 88 (for Cohort 4)
Time to First Confirmed Mycobacteria Growth Indicator Tube (MGIT) Culture Conversion of Clinical Specimen Sample
Culture conversion is defined as 2 consecutive negative cultures in the MGIT system at least 25 days apart with the last culture within the analysis window, unless a repeat microbiology sample (eg, lymph node biopsy) cannot be obtained.
Time frame: Baseline (Day 1), up to Week 120 (for Cohorts 1 to 3), Week 88 (for Cohort 4)
Time to Acid-Fast Bacilli (AFB) Smear Conversion of Clinical Specimen Sample
AFB smear conversion is defined as 2 consecutive negative AFB smear at least 25 days apart.
Time frame: Baseline (Day 1), up to Week 120 (for Cohorts 1 to 3), Week 88 (for Cohort 4)
This study is suspended, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bedaquiline
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