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NCT00164450 · ClinicalTrials.gov registry record · NA
TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection
A NA study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- NA
- Development phase
- 158
- Enrollment target
NCT00164450: Completed NA study, sponsored by Centers for Disease Control and Prevention.
NCT00164450 is a NA study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 158 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00164450, a NA study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- NA
- Development phase
- 158 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Rifapentine exposure was estimated in children and adults receiving once-weekly rifapentine plus isoniazid. A sparse sampling design used a plasma sample collected 24 hours after administration of study drugs.
Interventions
- DRUG Isoniazid
- DRUG Rifapentine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-08 |
| Phase | NA |
What the finished NCT00164450 record still lists
NCT00164450 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Isoniazid is the first listed.
NCT00164450 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00164450 about?
NCT00164450 is a clinical study titled "TBTC Study 26 PK: Rifapentine Pharmacokinetics in Children During Treatment of Latent TB Infection". 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 ...
What is the current status of trial NCT00164450?
This trial is currently completed. It is a NA study. The enrollment target is 158 participants. The study started on 2005-09. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00164450?
The interventions under investigation include: Isoniazid (DRUG), Rifapentine (DRUG).
Who is sponsoring clinical trial NCT00164450?
This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00164450's enrollment target sits among peer trials
158 654th of 2000 higher than 1,345 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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