drugset / Trial / NCT00453999

Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza

NCT00453999

Phase 2 Completed 137 enrolled BioCryst Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.

Timeline

Start
2007-07
Primary completion
2008-09
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Oseltamivir Small molecule 75 mg Oral
Subject PERAMIVIR ANHYDROUS Small molecule 200 mg Intravenous
Subject PERAMIVIR ANHYDROUS Small molecule 400 mg Intravenous

Indications