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

Status:	Recruiting
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any - 17
Updated:	10/6/2018
Start Date:	February 2015
End Date:	December 2019
Contact:	Clinical Trials Coordinator
Email:	clinicaltrials@biocryst.com

A Phase 3, Randomized, Open Label, Active-controlled Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of IV Peramivir Compared to Oral Oseltamivir in Pediatric Subjects With Acute Uncomplicated Influenza

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. Two thirds of the participants will
receive peramivir, while one third will receive oseltamivir.

Key Inclusion Criteria:

1. Clinical signs and symptoms consistent with acute influenza infection consisting of an
oral temperature ≥ 100°F (37.8°C) or rectal temperature ≥ 101.3ºF (≥ 38.5ºC) with at
least one respiratory symptom (cough or rhinitis) OR Positive influenza determined by
PCR or Rapid Antigen Test

2. Influenza symptom onset < 48 hours

Key Exclusion Criteria:

1. Pregnant or breast-feeding females

2. Development of symptoms while hospitalized

3. Presence of a chronic disease or illness that may indicate increased risk for
influenza-related complications

4. Presence of immunocompromised status

We found this trial at

sites

Peramivir investigative site

Splendora, Texas

from

Splendora, TX