A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza

Phase 3 Terminated 405 enrolled BioCryst Pharmaceuticals Department of Health and Human Services · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

A Phase 3, multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of peramivir administered intravenously in addition to standard of care compared to standard of care alone in adults and adolescents who are hospitalized due to serious influenza.

Timeline

Start: 2009-11
Primary completion: 2012-11
Completion: 2013-10

Outcome

Missed primary endpoint

Stopped: “This study was terminated for futility”

paper CONCLUSIONS: A significant clinical benefit was not demonstrated for peramivir plus SOC compared with placebo plus SOC. PMID 25115871 ↗

Publications

de Jong MD, Ison MG, Monto AS, Metev H, Clark C, O'Neil B, Elder J, McCullough A, Collis P, Sheridan WP. Evaluation of intravenous peramivir for treatment of influenza in hospitalized patients. Clin Infect Dis. 2014 Dec 15;59(12):e172-85. doi: 10.1093/cid/ciu632. Epub 2014 Aug 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PERAMIVIR ANHYDROUS	Small molecule	10 mg/kg	Intravenous
Subject	PERAMIVIR ANHYDROUS	Small molecule	600 mg	Intravenous