Evaluation of the Efficacy and Safety of Peramivir in Subjects With Uncomplicated Acute Influenza.
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.
Timeline
- Start
- 2007-01
- Primary completion
- 2007-09
- Completion
- 2007-09
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry analysis (superiority or other test); Placebo vs Peramivir 150 mg vs Peramivir 300 mg; p = 0.377; Regression, Cox reads as missed primary endpoint NCT00419263 ↗
release “Phase 2 study of intravenous (i.v.) peramivir, administered via a single dose injection in outpatients with acute, uncomplicated influenza, met its primary endpoint” reads as met primary endpoint biocryst.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PERAMIVIR ANHYDROUS | Small molecule | 150 mg | Intramuscular |
| Subject | PERAMIVIR ANHYDROUS | Small molecule | 300 mg | Intramuscular |