Safety, PK and Effectiveness of IV Peramivir in Elderly and Higher Risk Subjects With Uncomplicated Influenza

Status:	Completed
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	10/6/2018
Start Date:	December 2015
End Date:	September 2018

A Phase 3, Multicenter, Single-arm, Open-label, Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of Intravenous Peramivir in Elderly Subjects With Acute Uncomplicated Influenza Infection and in Subjects With Acute Uncomplicated Influenza Infection at Higher Risk for Influenza Complications

This study will evaluate the safety, pharmacokinetics and effectiveness of a single dose of
600 mg IV peramivir in the treatment of elderly subjects with acute uncomplicated influenza
infection and in subjects with acute uncomplicated influenza infection at higher risk for
influenza complications. All subjects will receive IV peramivir.

Inclusion Criteria:

- A positive influenza Rapid Antigen Test (RAT) and/or a FDA-approved PCR test and at
least one clinical sign or symptom consistent with acute influenza infection as listed
below OR

- Clinical signs and symptoms consistent with acute influenza infection consisting of an
oral temperature ≥ 100°F (37.8°C) with at least one respiratory symptom of at least
moderate severity (cough or rhinitis) and at least one constitutional symptom of at
least moderate severity (myalgia [aches and pains], headache, feverishness, or
fatigue)

- Influenza symptom onset < 48 hours

Exclusion Criteria:

- Pregnant females

- Subjects requiring hospital admission

- Recent worsening of any chronic medical condition consistent with complications of
influenza

- Current evidence of a bacterial infection requiring antibiotic treatment

We found this trial at

sites

Peramivir Investigational Site

Tampa, Florida

from

Tampa, FL