drugset / Trial / NCT02369159

Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza

NCT02369159

Phase 3 Completed 137 enrolled BioCryst Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of IV peramivir compared to a standard 5 day course of oral oseltamivir in the treatment of pediatric subjects with acute uncomplicated influenza.

Timeline

Start
2015-03-11
Primary completion
2019-10-28
Completion
2020-05-14

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oseltamivir Small molecule 75 mg Oral
Subject PERAMIVIR ANHYDROUS Small molecule 8 mg/kg Intravenous
Subject PERAMIVIR ANHYDROUS Small molecule 12 mg/kg Intravenous
Subject PERAMIVIR ANHYDROUS Small molecule 600 mg Intravenous

Indications