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

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ClinicalTrials.gov Identifier: NCT02369159
Recruitment Status : Completed
First Posted : February 23, 2015
Results First Posted : March 23, 2021
Last Update Posted : March 23, 2021
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.

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 Number of Participants Experiencing Adverse Events. [ Time Frame: 14 days ]
    Safety evaluation included assessment of Adverse Events (AEs).


Secondary Outcome Measures :
  1. Plasma Exposure of IV Peramivir as Measured by the Drug Concentration Over 6 Hours Post-dose [ Time Frame: up to 6 hours post peramivir infusion ]
    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.

  2. Time to Resolution of Fever [ Time Frame: 14 days ]
    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.

  3. Time to Resolution of Influenza Symptoms [ Time Frame: 14 days ]
    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.

  4. Time to Reduction in Viral Shedding [ Time Frame: 14 days ]
    Assessment of viral shedding in bilateral, mid-nasal swab specimens taken at baseline and then on Day 3, 7 and 14.

  5. Changes in Influenza Virus Titer in Nasopharyngeal Samples in Response to Treatment. [ Time Frame: Change from baseline assessed on days 3, 7 and 14. ]
    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.

  6. Influenza-Related Complications Assessment. [ Time Frame: 14 days ]
    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.



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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
  Study Documents (Full-Text)

Documents provided by BioCryst Pharmaceuticals:
Study Protocol  [PDF] November 5, 2018
Statistical Analysis Plan  [PDF] July 11, 2016

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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
Results First Posted: March 23, 2021
Last Update Posted: March 23, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Oseltamivir
Peramivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action