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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Peramivir
Oseltamivir
Sponsored by
BioCryst Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza

Eligibility Criteria

0 Days - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peramivir Investigative Site
  • Peramivir investigative site
  • Peramivir investigative site
  • Peramivir Investigative Site
  • Peramivir investigative site
  • Peramivir investigative site
  • Peramivir investigative site
  • Peramivir investigative site
  • Peramivir investigative site
  • Peramivir Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peramivir (IV)

Oseltamivir

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Safety evaluation included assessment of Adverse Events (AEs).

Secondary Outcome Measures

Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose
Up to 4 blood samples will be drawn, where possible: immediately following infusion and 30 to 60 mins, 1 to 3 hrs and 4 to 6 hrs post-infusions. AUC calculations were performed in Phoenix WinNonlin using the linear/log trapezoidal rule. AUC0-last was calculated between start of the infusion and the time of the last measurable concentration.
Time to Resolution of Fever
Time for fever resolution based on subject diary record of temperature recorded twice daily. A subject had resolution of fever if he/she had oral temperature of < 99.4°F or an axillary temperature of < 98.4°F and no antipyretic medications were taken for ≥ 12 hours. The time to resolution of fever was estimated for each age group and overall using the Kaplan-Meier method with temperature and symptom relief medication information obtained from the Subject Diary data.
Time to Resolution of Influenza Symptoms
Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a 4-point severity scale (0,absent; 1, mild; 2, moderate; 3, severe) twice daily beginning before screening on Day 1 until symptoms resolved or until the last follow-up visit. Time to alleviation of symptoms was the number of hours from initiation of study drug until the start of the time period in which all age-appropriate symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 - 10%) hours. Subjects who did not experience alleviation of symptoms were censored at the last observed symptom assessment.
Time to Reduction in Viral Shedding
Assessment of viral shedding in bilateral, mid-nasal swab specimens taken at baseline and then on Day 3, 7 and 14.
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Change in influenza viral titers was defined as the time-weighted change from Baseline in log_10 tissue culture infective dose_50 (TCID50/mL) and was summarized for each treatment group.
Influenza-Related Complications Assessment.
The investigator performed a full physical exam at baseline. At each follow-up visit, study personnel evaluated the subject for the presence of clinical signs and symptoms of the following influenza-related complications: sinusitis, otitis media, bronchitis, and pneumonia requiring antibiotic use, diagnosed after initiation of treatment.

Full Information

First Posted
February 17, 2015
Last Updated
February 26, 2021
Sponsor
BioCryst Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02369159
Brief Title
Safety, PK and Effectiveness of IV Peramivir Versus Oseltamivir in Pediatric Subjects With Uncomplicated Influenza
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 Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2015 (Actual)
Primary Completion Date
October 28, 2019 (Actual)
Study Completion Date
May 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioCryst Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peramivir (IV)
Arm Type
Experimental
Arm Description
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.
Arm Title
Oseltamivir
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Peramivir
Intervention Type
Drug
Intervention Name(s)
Oseltamivir
Primary Outcome Measure Information:
Title
Safety and Tolerability, as Measured by the Number of Participants Experiencing Adverse Events.
Description
Safety evaluation included assessment of Adverse Events (AEs).
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose
Description
Up to 4 blood samples will be drawn, where possible: immediately following infusion and 30 to 60 mins, 1 to 3 hrs and 4 to 6 hrs post-infusions. AUC calculations were performed in Phoenix WinNonlin using the linear/log trapezoidal rule. AUC0-last was calculated between start of the infusion and the time of the last measurable concentration.
Time Frame
up to 6 hours post peramivir infusion
Title
Time to Resolution of Fever
Description
Time for fever resolution based on subject diary record of temperature recorded twice daily. A subject had resolution of fever if he/she had oral temperature of < 99.4°F or an axillary temperature of < 98.4°F and no antipyretic medications were taken for ≥ 12 hours. The time to resolution of fever was estimated for each age group and overall using the Kaplan-Meier method with temperature and symptom relief medication information obtained from the Subject Diary data.
Time Frame
14 days
Title
Time to Resolution of Influenza Symptoms
Description
Subjects or parents or caregivers were asked to provide an assessment of age-appropriate influenza symptoms on a 4-point severity scale (0,absent; 1, mild; 2, moderate; 3, severe) twice daily beginning before screening on Day 1 until symptoms resolved or until the last follow-up visit. Time to alleviation of symptoms was the number of hours from initiation of study drug until the start of the time period in which all age-appropriate symptoms of influenza were either absent or present at a level no greater than mild for at least 21.5 (24 - 10%) hours. Subjects who did not experience alleviation of symptoms were censored at the last observed symptom assessment.
Time Frame
14 days
Title
Time to Reduction in Viral Shedding
Description
Assessment of viral shedding in bilateral, mid-nasal swab specimens taken at baseline and then on Day 3, 7 and 14.
Time Frame
14 days
Title
Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment.
Description
Change in influenza viral titers was defined as the time-weighted change from Baseline in log_10 tissue culture infective dose_50 (TCID50/mL) and was summarized for each treatment group.
Time Frame
Change from baseline assessed on days 3, 7 and 14.
Title
Influenza-Related Complications Assessment.
Description
The investigator performed a full physical exam at baseline. At each follow-up visit, study personnel evaluated the subject for the presence of clinical signs and symptoms of the following influenza-related complications: sinusitis, otitis media, bronchitis, and pneumonia requiring antibiotic use, diagnosed after initiation of treatment.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Vanchiere, MD, PhD
Organizational Affiliation
Chief, Pediatric Infectious Diseases, Louisiana State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peramivir Investigative Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Peramivir investigative site
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Peramivir investigative site
City
Smithfield
State/Province
Pennsylvania
Country
United States
Facility Name
Peramivir Investigative Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Peramivir investigative site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Peramivir investigative site
City
Splendora
State/Province
Texas
Country
United States
Facility Name
Peramivir investigative site
City
Draper
State/Province
Utah
Country
United States
Facility Name
Peramivir investigative site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Peramivir investigative site
City
South Jordan
State/Province
Utah
Country
United States
Facility Name
Peramivir Investigative Site
City
Pretoria
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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