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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02369159
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
BioCryst Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Influenza Drug: Peramivir Drug: Oseltamivir Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 11, 2015
Actual Primary Completion Date : October 28, 2019
Actual Study Completion Date : May 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Peramivir (IV)

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
Active Comparator: Oseltamivir

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



Primary Outcome Measures :
  1. Safety and tolerability, as measured by the incidence of adverse events and laboratory abnormalities [ Time Frame: 14 days ]
    • Safety will be evaluated through assessments of Adverse Events (AEs), laboratory analyses (clinical chemistry, hematology and urinalysis), vital signs, and physical examinations.


Secondary Outcome Measures :
  1. Plasma exposure of IV peramivir as measured by the drug concentration over 6 hours post-dose [ Time Frame: 6 hours ]
    Up to 4 blood samples will be drawn, where possible, from the time immediately following completion of the infusion through 6 hours post-infusion

  2. Time to resolution of fever [ Time Frame: 14 days ]
    Time for fever resolution based on subject diary record of temperature recorded twice daily

  3. Time to resolution of influenza symptoms [ Time Frame: 14 days ]
    Time to resolution of age-specific signs and symptoms of influenza based on subject diary record of symptoms recorded twice daily

  4. Time to reduction in viral shedding [ Time Frame: 14 days ]
    Assessment of quantitative viral shedding in nasal swabs taken on Day 1,3,7 and 14



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369159


Locations
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United States, Louisiana
Peramivir Investigative Site
Shreveport, Louisiana, United States
United States, Ohio
Peramivir investigative site
Dayton, Ohio, United States
United States, Pennsylvania
Peramivir investigative site
Smithfield, Pennsylvania, United States
United States, Texas
Peramivir Investigative Site
Houston, Texas, United States
Peramivir investigative site
San Antonio, Texas, United States
Peramivir investigative site
Splendora, Texas, United States
United States, Utah
Peramivir investigative site
Draper, Utah, United States
Peramivir investigative site
Salt Lake City, Utah, United States
Peramivir investigative site
South Jordan, Utah, United States
South Africa
Peramivir Investigative Site
Pretoria, South Africa
Sponsors and Collaborators
BioCryst Pharmaceuticals
Investigators
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Principal Investigator: John Vanchiere, MD, PhD Chief, Pediatric Infectious Diseases, Louisiana State University
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Responsible Party: BioCryst Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02369159    
Other Study ID Numbers: BCX1812-305
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Peramivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action