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Report for Clinical Trial NCT01063933

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Investigational Intravenous Peramivir in Children With Influenza Disease (CASG 117)

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.

NCT01063933 Influenza
MeSH:Influenza, Human

1 Interventions

Name: Peramivir

Description: 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.
Type: Drug
Group Labels: 7

Cohort I Cohort II Cohort III Cohort IV Cohort V Cohort VI Cohort VII


Primary Outcomes

Measure: Peramivir dose that provides area under the curve (AUC)24 between 60 microgram (mcg) hour(hr)/liter (L) and 94 mcg hr/L.

Time: 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.

Measure: Pharmacokinetic parameters for peramivir, including AUC24, maximum serum concentration (Cmax), half-life (T1/2), Clearance (CL), and time to maximum concentration (Tmax).

Time: 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

Measure: Safety: overall incidence of adverse events.

Time: Day 1 to Day 28

Measure: Safety: the incidence of grade 3-4 adverse events or severe adverse events.

Time: Day 1 to Day 28

Measure: Safety: the incidence of adverse events considered to be related to study treatment.

Time: Day 1 to Day 28

Measure: Safety: the incidence of adverse events leading to discontinuation of study drug.

Time: Day 1 to Day 28

Measure: Virologic: proportion of subjects who are negative for viral ribonucleic acid (RNA) by reverse transcriptase-polymerase chain reaction (PCR).

Time: Day 3, 5, and 10.

Measure: Virologic: incidence of treatment emergent peramivir resistant virus.

Time: Study days 1, 3, 5, and 10.

Measure: Virologic: time to no detectable viral ribonucleic acid (RNA) by polymerase chain reaction (PCR).

Time: Study days 1, 3, 5, and 10.

Measure: Virologic: quantitative viral load over time.

Time: Study days 1, 3, 5, and 10.

Measure: Safety: the incidence of severe or grade 3 and 4 treatment related adverse events.

Time: Day 1 to Day 28

Measure: Safety: the incidence of treatment-related serious adverse events.

Time: Day 1 to Day 28

Measure: Safety: the incidence of serious adverse events and deaths.

Time: Day 1 to Day 28

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 H275Y

-Documented H275Y mutation (note: it is unlikely that resistance testing will have been completed for most subjects). --- H275Y ---



HPO Nodes