Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Peramivir in Children With Influenza
A Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Investigational Intravenous Peramivir in Children With Influenza Disease (CASG 117)
4 other identifiers
interventional
N/A
1 country
29
Brief Summary
The purposes of this study are to evaluate the pharmacokinetics (affect the body has on a drug), and pharmacodynamics (affect the drug has on the body) and safety of an experimental intravenous (within a vein) flu medication, peramivir, in children. Participants will include 63 hospitalized children with confirmed flu. Children will be grouped according to age and younger children will not receive drug until safety data from the groups of older children are reviewed. Hospitalized children may receive up to 5 doses of peramivir. Study procedures include: nasal/throat swabs, reporting any experienced side effects, physical examination including assessment of the nervous system, and blood sample collection. Participants will be involved in study related procedures for up to 28 days.
Trial Health
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29 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 11, 2011
January 1, 2010
February 4, 2010
November 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Peramivir dose that provides area under the curve (AUC)24 between 60 microgram (mcg) hour(hr)/liter (L) and 94 mcg hr/L.
Within 15 minutes prior to dosing, and at the following timepoints measured from the time of the start of the infusion: 1-1.25 hours (end of infusion), 2-3 hours, 5-7 hours, 10-12 hours, and 22-24 hours post-dosing.
Pharmacokinetic parameters for peramivir, including AUC24, maximum serum concentration (Cmax), half-life (T1/2), Clearance (CL), and time to maximum concentration (Tmax).
Within 15 minutes prior to dosing, and at the following timepoints measured from the time of the start of the infusion: 1-1.25 hours (end of infusion), 2-3 hours, 5-7 hours, 10-12 hours, and 22-24 hours post-dosing.
Secondary Outcomes (11)
Safety: overall incidence of adverse events.
Day 1 to Day 28
Safety: the incidence of grade 3-4 adverse events or severe adverse events.
Day 1 to Day 28
Safety: the incidence of adverse events considered to be related to study treatment.
Day 1 to Day 28
Safety: the incidence of adverse events leading to discontinuation of study drug.
Day 1 to Day 28
Virologic: proportion of subjects who are negative for viral ribonucleic acid (RNA) by reverse transcriptase-polymerase chain reaction (PCR).
Day 3, 5, and 10.
- +6 more secondary outcomes
Study Arms (7)
Cohort I
EXPERIMENTALCohort I: \>/= 12 years to \< 18 years. Peramivir administered daily for five days or until the day of hospital discharge, whichever comes first.
Cohort II
EXPERIMENTALCohort II: \>/= 6 years to \< 12 years
Cohort III
EXPERIMENTALCohort III: \>/= 2 years to \< 6 years
Cohort V
EXPERIMENTALCohort V: \>/= 91 days to \< 181 days
Cohort VII
EXPERIMENTALCohort VII: birth to \< 31 days
Cohort VI
EXPERIMENTALCohort VI: \>/= 31 days to \< 91 days
Cohort IV
EXPERIMENTALCohort IV: \>/= 181 days to \< 2 years
Interventions
Peramivir is a liquid for parenteral administration. Cohort I: Peramivir, 10 mg/kg intravenously (IV) every day (QD) (maximum of 600 mg/day) for 5 days or until hospital discharge, whichever comes first. Cohort II: Peramivir 12 mg/kg IV QD (maximum of 600 mg/day) for 5 days or until hospital discharge, whichever comes first. Cohort III: Peramivir 16 mg/kg QD (maximum of 600 mg/day) for 5 days or until hospital discharge, whichever comes first. Proposed doses for subjects in Cohorts IV, V, VI, and VII are 18, 18, 14 and 12 mg/kg, respectively, IV, QD for 5 days or until hospital discharge, whichever comes first. IV peramivir will be administered over 60 minutes.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Stanford University
Stanford, California, 94306, United States
The Children's Hospital - Denver, Colorado
Denver, Colorado, 80218, United States
Childrens National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of South Florida
Tampa, Florida, 33606, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Tulane University
New Orleans, Louisiana, 70112, United States
Louisiana State University
Shreveport, Louisiana, 71103, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-5400, United States
The Children's Hospital at Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
North Shore-Long Island Jewish Health System
Manhasset, New York, 11030, United States
NYU School of Medicine
New York, New York, 10016, United States
New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
SUNY at Stony Brook
Stony Brook, New York, 11794-8111, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Vanderbilt University
Nashville, Tennessee, 37232-2581, United States
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
Study Record Dates
First Submitted
February 4, 2010
First Posted
February 5, 2010
Primary Completion
August 1, 2011
Study Completion
December 1, 2012
Last Updated
November 11, 2011
Record last verified: 2010-01