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NCT00419263 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.
A Phase 2 study, sponsored by BioCryst Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 344
- Enrollment target
NCT00419263: Completed Phase 2 study, sponsored by BioCryst Pharmaceuticals.
NCT00419263 is a Phase 2 study that has completed, run by BioCryst Pharmaceuticals. The registered enrollment target is 344 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (159% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00419263, a Phase 2 study, has completed, sponsored by BioCryst Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 344 participants
- Enrollment target
Study Summary
This is a study for patients with flu who also have a fever as well as other flu symptoms. Patients must have had symptoms for less than 48 hours in order to participate. Patients will have two out of three chances of getting an active study treatment and the other third will receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to be seen 5 more times after they are enrolled in the study.
Primary Outcome
Descriptive statistics for the primary efficacy variables were tabulated by treatment group. Alleviation of symptoms was determined by data recorded in the Subject Diary. Treatment differences were assessed using a Cox Regression model with effects for current smoking behavior, treatment, and geographic region. Subjects who did not experience alleviation of symptoms were censored at the date of their last assessment. A Bonferroni adjustment for the primary comparisons of each active dose with pl
Interventions
- DRUG Placebo
- DRUG Peramivir 150 mg
- DRUG Peramivir 300 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2007-01 |
| Est. Completion | 2007-09 |
| Phase | Phase 2 |
What the finished NCT00419263 record still lists
NCT00419263 is an interventional study that assigns participants to a tested intervention. The registered 344 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 (159% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00419263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00419263 about?
NCT00419263 is a clinical study titled "Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.". This is a study for patients with flu who also have a fever as well as other flu symptoms. Patients must have had symptoms for less than 48 hours in order to participate. Patients will have two out of three chances of getting an active study treatment and the other third will receive a placebo (dumm...
What is the current status of trial NCT00419263?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 344 participants. The study started on 2007-01. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00419263?
The interventions under investigation include: Placebo (DRUG), Peramivir 150 mg (DRUG), Peramivir 300 mg (DRUG).
Who is sponsoring clinical trial NCT00419263?
This trial is sponsored by BioCryst Pharmaceuticals, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00419263's enrollment target sits among peer trials
344 136th of 2000 higher than 1,865 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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