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

NCT02369159 | Completed Phase 3 Results DMC

• 1 other identifier: BCX1812-305
• Study Type: interventional
• Target: 137
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.

  Safety evaluation included assessment of Adverse Events (AEs).

  14 days

Secondary Outcomes (6)

• Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose

  up to 6 hours post peramivir infusion

• Time to Resolution of Fever

  14 days

• Time to Resolution of Influenza Symptoms

  14 days

• Time to Reduction in Viral Shedding

  14 days

• Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.

  Change from baseline assessed on days 3, 7 and 14.

Study Arms (2)

Peramivir (IV)

EXPERIMENTAL

Subjects randomized to peramivir will receive an age appropriate single dose, diluted to a maximum volume of 100 mL in normal saline, administered as a short intravenous infusion over a minimum of 15 minutes. * Subjects ≥12 years will receive a dose of 600 mg. * Subjects \<12 years will receive a dose of 12 mg/kg (to a maximum dose of 600 mg). * Subjects \< 6 months will receive a dose of 8 mg/kg.

Drug: Peramivir

Oseltamivir

ACTIVE COMPARATOR

Subjects randomized to oral oseltamivir will receive an age appropriate dose twice daily for 5 days. * Subjects ≥ 13 years will receive a 75mg dose administered as a capsule or oral suspension (twice daily for 5 days). * Subjects \< 13 years of age will receive a weight-based dose administered as a capsule or oral suspension (twice daily for 5 days).

Drug: Oseltamivir

Interventions

Peramivir DRUG

Peramivir (IV)

Oseltamivir DRUG

Oseltamivir

Eligibility Criteria

• Age: 0 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Onset of symptoms no more than 72 hours before presentation for screening for subjects \< 2 years old.

You may not qualify if:

• Pregnant or breast-feeding females
• Development of symptoms while hospitalized
• Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications
• Presence of immunocompromised status

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead

Study Sites (10)

Peramivir Investigative Site

Shreveport, Louisiana, United States

Location

Peramivir investigative site

Dayton, Ohio, United States

Location

Peramivir investigative site

Smithfield, Pennsylvania, United States

Location

Peramivir Investigative Site

Houston, Texas, United States

Location

Peramivir investigative site

San Antonio, Texas, United States

Location

Peramivir investigative site

Splendora, Texas, United States

Location

Peramivir investigative site

Draper, Utah, United States

Location

Peramivir investigative site

Salt Lake City, Utah, United States

Location

Peramivir investigative site

South Jordan, Utah, United States

Location

Peramivir Investigative Site

Pretoria, South Africa

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

peramivir; Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Study Director
• Organization: BioCryst Pharmaceuticals Inc

clinicaltrials@biocryst.com

+1 919-859-1302

Study Officials

• John Vanchiere, MD, PhD

  Chief, Pediatric Infectious Diseases, Louisiana State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: February 23, 2015
• Study Start: March 11, 2015
• Primary Completion: October 28, 2019
• Study Completion: May 14, 2020
• Last Updated: March 23, 2021
• Results First Posted: March 23, 2021

Record last verified: 2021-02

Locations

ZA (1); US (9)