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

Information source: BioCryst Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Peramivir (Drug); Oseltamivir (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: BioCryst Pharmaceuticals

Official(s) and/or principal investigator(s):
John Vanchiere, MD, PhD, Principal Investigator, Affiliation: Chief, Pediatric Infectious Diseases, Louisiana State University

Overall contact:
Clinical Trials Coordinator, Email: clinicaltrials@biocryst.com

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Safety and tolerability, as measured by the incidence of adverse events and laboratory abnormalities

Secondary outcome:

Plasma exposure of IV peramivir as measured by the drug concentration over 6 hours post-dose

Time to resolution of fever

Time to resolution of influenza symptoms

Time to reduction in viral shedding

Eligibility

Minimum age: 2 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria: 1. 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

Locations and Contacts

Clinical Trials Coordinator, Email: clinicaltrials@biocryst.com

Peramivir Investigative Site, Shreveport, Louisiana, United States; Not yet recruiting

Peramivir Investigative Site, Troy, Michigan, United States; Recruiting

Peramivir Investigative Site, Nashville, Tennessee, United States; Not yet recruiting

Peramivir Investigative Site, Houston, Texas, United States; Not yet recruiting

Peramivir investigative site, Salt Lake City, Utah, United States; Recruiting

Additional Information

Starting date: February 2015
Last updated: March 11, 2015

Page last updated: August 23, 2015

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