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NCT01408914 · ClinicalTrials.gov registry record · Phase 2
Trial of High-Dose Rifampin in Patients With TB
A Phase 2 study, sponsored by Harvard University Faculty of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
NCT01408914: Completed Phase 2 study, sponsored by Harvard University Faculty of Medicine.
NCT01408914 is a Phase 2 study that has completed, run by Harvard University Faculty of Medicine. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01408914, a Phase 2 study, has completed, sponsored by Harvard University Faculty of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the potential of high doses of rifampin (RIF) to shorten treatment for tuberculosis (TB) without causing more adverse events. The hypotheses are that higher doses of RIF will result in higher blood concentrations of RIF; higher blood concentrations will result in tuberculosis bugs being killed more quickly; and, both of these will happen without more adverse events. Patients with active, infectious, drug-susceptible TB who agree to participate will be randomly assigned to 1 of 3 doses of RIF. All patients will also receive standard doses of regular (3) companion drugs for 2 months of daily, supervised therapy. The study will assess the following among the 3 study arms (oral doses of RIF 10, 15 \& 20 mg/kg/day) during the initial 8 weeks of treatment: 1) the amount of RIF in the blood after at least 14 days of treatment; 2) the difference in the number of tuberculosis bugs killed; 3) the frequency of adverse events.
Primary Outcome
The endpoint is the (dimensionless) ratio of AUC0-6 mcg/ml\*h to MIC99.9 mcg/ml
Interventions
- DRUG Higher-Dose Rifampin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01408914 record still lists
NCT01408914 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 1 intervention - of which Higher-Dose Rifampin is the first listed.
NCT01408914 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01408914 about?
NCT01408914 is a clinical study titled "Trial of High-Dose Rifampin in Patients With TB". The purpose of this study is to evaluate the potential of high doses of rifampin (RIF) to shorten treatment for tuberculosis (TB) without causing more adverse events. The hypotheses are that higher doses of RIF will result in higher blood concentrations of RIF; higher blood concentrations will resul...
What is the current status of trial NCT01408914?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2013-09. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01408914?
The interventions under investigation include: Higher-Dose Rifampin (DRUG).
Who is sponsoring clinical trial NCT01408914?
This trial is sponsored by Harvard University Faculty of Medicine, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01408914's enrollment target sits among peer trials
180 365th of 2000 higher than 1,610 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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