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

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

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Peramivir 200 mg vs Peramivir 400 mg vs Oseltamivir; p = 0.306; Log Rank NCT00453999 ↗

paper Median times (95% CI) to clinical stability were 37.0 h (22.0, 48.7) with peramivir 400 mg, 23.7 h (16.0, 38.9) with peramivir 200 mg and 28.1 h (22.0, 37.0) with oseltamivir (P=0.306). PMID 23111657 ↗

Publications

• Ison MG, Hui DS, Clezy K, O'Neil BJ, Flynt A, Collis PJ, Simon TJ, Alexander WJ. A clinical trial of intravenous peramivir compared with oral oseltamivir for the treatment of seasonal influenza in hospitalized adults. Antivir Ther. 2013;18(5):651-61. doi: 10.3851/IMP2442. Epub 2012 Oct 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Oseltamivir	Small molecule	75 mg	Oral
Subject	PERAMIVIR ANHYDROUS	Small molecule	200 mg	Intravenous
Subject	PERAMIVIR ANHYDROUS	Small molecule	400 mg	Intravenous

Indications