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NCT02410772 · ClinicalTrials.gov registry record · Phase 3
TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens
A Phase 3 study, sponsored by Centers for Disease Control and Prevention.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,516
- Enrollment target
NCT02410772: Completed Phase 3 study, sponsored by Centers for Disease Control and Prevention.
NCT02410772 is a Phase 3 study that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 2,516 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (226% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02410772, a Phase 3 study, has completed, sponsored by Centers for Disease Control and Prevention.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,516 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week, with direct observation of each dose by a health-care worker at least five of the seven days of each week. The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide followed by four months of isoniazid and rifampin. The first short regimen is a single substitution of rifapentine for rifampin: two months of isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and rifapentine. The second short regimen is a double substitution of rifapentine for rifampin and moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin. Target enrollment is 2500 participants. Each study participant will remain in the study for 18 months in order to include at least 12 months of evaluation of whether the participant's TB recurs.
Primary Outcome
To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the dura
Interventions
- DRUG control
- DRUG rifapentine
- DRUG rifapentine and moxifloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,516 participants |
| Start Date | 2016-01-25 |
| Est. Completion | 2021-05 |
| Phase | Phase 3 |
What the finished NCT02410772 record still lists
NCT02410772 is an interventional study that assigns participants to a tested intervention. Its 2,516 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (226% higher).
The record links to 0 conditions, and to 3 interventions - of which control is the first listed.
NCT02410772 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02410772 about?
NCT02410772 is a clinical study titled "TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens". The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week, with direct observation of each d...
What is the current status of trial NCT02410772?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,516 participants. The study started on 2016-01-25. Estimated completion is 2021-05.
What interventions are being tested in trial NCT02410772?
The interventions under investigation include: control (DRUG), rifapentine (DRUG), rifapentine and moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT02410772?
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 NCT02410772's enrollment target sits among peer trials
2,516 88th of 2000 higher than 1,913 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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