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TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results first posted: Jul 7, 2026 Primary endpoints: 1 to 2 · Enrollment target: estimated 230 to confirmed 158 · Interventions: Rifapentine + isoniazid once weekly for 3 months (Drug) to Isoniazid (Drug), Rifapentine (Drug) · 3 morev5 Show all 7 changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: estimated 230 to confirmed 158
    • Interventions: Rifapentine + isoniazid once weekly for 3 months (Drug) to Isoniazid (Drug), Rifapentine (Drug)
    • Secondary endpoints: 5 to 1
    • Site details revised at 1 of 24 sites
    • Study arms: 0 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoint revised Trial status: Recruiting to Completed · Primary and study completion dates: Aug 2008 · Secondary endpoints: details revised at 5 of 5 entries · 1 morev4 Show all 5 changesShow less
    • Trial status: Recruiting to Completed
    • Primary and study completion dates: Aug 2008
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 24 of 24 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting Primary endpoint revised · Study sites: 23 to 24 · Secondary endpoints revised (5)v2 Show all 4 changesShow less
    • Primary endpoint revised
    • Study sites: 23 to 24
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Compared to adults, children appear to require higher weight-based doses of rifapentine to acheive comparable drug levels. TBTC Study 26, a study of the effectiveness and tolerability of weekly rifapentine/isoniazid for three months versus daily isoniazid for nine months for the treatment of latent tuberculosis infection, has been amended to include children ages 2-11 based on an initial single-dose study and pharmacokinetic modeling. Study 26PK evaluates the adequacy of the doses chosen for young children enrolled in Study 26 with a single blood draw, 24 hours after the third or subsequent weekly Study 26 dose of rifapentine and isoniazid. An adult control is enrolled for each child enrolled.
Trial Details
NCT Number NCT00164450
Lead Sponsor Centers for Disease Control and Prevention
Collaborators: US Department of Veterans Affairs
Conditions Tuberculosis
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov