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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

StatusSuspended
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 98 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Recruitment suspended Sponsor's reason: As part of the protocol-specified interim pharmacokinetic (PK) evaluation in Study TMC207-C211, PK data demonstrated lower-than-anticipated bedaquiline exposure Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC · Eligibility criteria shortened, about 24 words · Study sites revised (11) Show 3 more changesShow less
    • Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC
    • Eligibility criteria shortened, about 24 words
    • Study sites revised (11)
  2. Site details revised at 1 of 11 sitesv97
  3. 3 versions Re-verified since Apr 9, 2026, no change to tracked fieldsv94-v96
  4. Eligibility criteria expanded, about 30 wordsv93 See this version in full on ClinicalTrials.gov ↗
  5. Completion date: Feb 11, 2027 to Nov 2, 2028v92
Show 43 earlier versionsHide 43 earlier versions
  1. 5 versions Re-verified since Sep 11, 2025, no change to tracked fieldsv87-v91
  2. Study sites: 10 to 11 Eligibility criteria expanded, about 57 wordsv86 Show 1 more changeShow less
    • Eligibility criteria expanded, about 57 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv85
  4. Study sites: 9 to 10v84
  5. Site details revised at 4 of 9 sitesv83
  6. Study sites: 8 to 9v82
  7. Re-verified, no change to tracked fieldsv81
  8. Primary completion date: Feb 21, 2025 to Feb 11, 2027v80
  9. 2 versions Re-verified since Dec 9, 2024, no change to tracked fieldsv78-v79
  10. Primary completion date: Feb 2025 to Feb 21, 2025 Completion date: Feb 2027 to Feb 11, 2027 · Start date: May 2016 to May 3, 2016v77 Show 2 more changesShow less
    • Completion date: Feb 2027 to Feb 11, 2027
    • Start date: May 2016 to May 3, 2016
  11. 16 versions Re-verified since Jul 19, 2023, no change to tracked fieldsv61-v76
  12. Primary completion date: Feb 21, 2025 to Feb 2025 Completion date: Jul 13, 2025 to Feb 2027 · Start date: May 3, 2016 to May 2016v60 Show 2 more changesShow less
    • Completion date: Jul 13, 2025 to Feb 2027
    • Start date: May 3, 2016 to May 2016
  13. Re-verified, no change to tracked fieldsv59
  14. Study sites: 9 to 8v58
  15. 3 versions Re-verified since Jan 17, 2023, no change to tracked fieldsv55-v57
  16. Study Status, Arms and Interventions, Outcome Measures, Eligibilityv54
  17. 3 versions Re-verified since Sep 27, 2022, no change to tracked fieldsv51-v53
  18. Site details revised at 2 of 9 sitesv50
  19. Re-verified, no change to tracked fieldsv49
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02354014
Lead Sponsor Janssen Research & Development, LLC
Conditions Tuberculosis, Multidrug-Resistant
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov