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Pharmacokinetic/Pharmacodynamic and Safety Evaluation of Intravenous Peramivir in Children With Influenza

2014-08-27 03:16:07 | BioPortfolio

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 35 days.

Description

Infants and young children are at greatest risk of mortality from epidemic influenza. Influenza medications currently approved for use in the United States are administered orally or via inhalation. Availability of a parenteral influenza medication could be of great importance in medical and public health responses to both seasonal and pandemic influenza. Peramivir is an experimental parenteral influenza drug that is in advanced stages of clinical development. The primary objective of this study is to define the pharmacokinetics (PK) of peramivir in children with confirmed influenza. The secondary objectives are to: assess the safety and tolerability of intravenous (IV) peramivir in children with influenza; assess viral dynamics as a function of drug PK; and assess virus susceptibility to peramivir. This study is a prospective, open-label, age-stratified PK/pharmacodynamic (PD) and safety evaluation of investigational IV peramivir in hospitalized children with influenza infection who have failed or are unable to receive oseltamivir or zanamivir therapy. A minimum of 63 children with confirmed influenza will be enrolled into 1 of 7 age cohorts: 13 years through 17 years (Cohort I); 6 years through 12 years (Cohort II); 2 years through 5 years (Cohort III); 181 days through 23 months (Cohort IV); 91 days through 180 days (Cohort V); 31 days through 90 days (Cohort VI); birth through 30 days (Cohort VII). Only hospitalized children will be enrolled. At study onset, Cohorts I and II (children from 6 through 17 years of age) will be enrolled initially. When PK and safety data from a total of 5 subjects enrolled in Cohort I or Cohort II are available, the study's Data and Safety Monitoring Board (DSMB) will review and may request the opening of Cohort III to enrollment. As safety and supporting PK data become available for subjects in Cohort III, the study's DSMB may authorize the opening of Cohorts IV, V, VI, and VII; this determination may occur prior to full enrollment in Cohort III. This more cautious approach will allow the evaluation of some safety and PK data prior to exposure of youngest children to an untested dose, even though it is likely that younger children may receive peramivir under emergency use conditions. The doses selected for use were based on modeling since no pediatric patients have received peramivir in clinical trials. In the current study, PK data will be obtained in a real time basis, and doses in each cohort may be modified if the target exposure [area under the curve (AUC) 24] falls outside of a pre-specified range. Additional enrollments may be allowed if the dose requires modification in a given cohort. In the event of a public health emergency, the National Institutes of Health (NIH), DSMB, or Food and Drug Administration (FDA) may authorize the opening of new cohorts, the re-opening of previously closed cohorts to obtain additional data, and/or the over enrollment of any of the 7 cohorts. Subjects will receive IV Peramivir once daily for 5 days or until the day of hospital discharge, whichever comes first, and PK draws will be obtained around the second dose. Because subjects either must have failed oseltamivir or zanamivir treatment or must be unable to take these medications, clinical co-administration of other antivirals for influenza (e.g. inhaled zanamavir, ribavirin, oral oseltamivir, and/or an adamantane) will not be allowed while the subject is receiving peramivir. In addition to PK and PD, this study will carefully assess clinical disease course and adverse events (AEs), including neurologic AEs. Safety evaluations also will include neurologic assessments, general physical assessments, and AE and serious adverse event (SAE) reporting. Sequential nasopharyngeal specimens will be obtained for virologic assessments, including viral cultures, polymerase chain reaction (PCR) for viral ribonucleic acid (RNA) (quantitative), and analysis of antiviral resistance.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Influenza

Intervention

Peramivir

Location

University of Alabama at Birmingham
Birmingham
Alabama
United States
35233

Status

Not yet recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:07-0400

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Medical and Biotech [MESH] Definitions

Species of the genus INFLUENZAVIRUS B that cause HUMAN INFLUENZA and other diseases primarily in humans. Antigenic variation is less extensive than in type A viruses (INFLUENZA A VIRUS) and consequently there is no basis for distinct subtypes or variants. Epidemics are less likely than with INFLUENZA A VIRUS and there have been no pandemics. Previously only found in humans, Influenza B virus has been isolated from seals which may constitute the animal reservoir from which humans are exposed.

Membrane glycoproteins from influenza viruses which are involved in hemagglutination, virus attachment, and envelope fusion. Fourteen distinct subtypes of HA glycoproteins and nine of NA glycoproteins have been identified from INFLUENZA A VIRUS; no subtypes have been identified for Influenza B or Influenza C viruses.

Infection of domestic and wild fowl and other BIRDS with INFLUENZA A VIRUS. Avian influenza usually does not sicken birds, but can be highly pathogenic and fatal in domestic POULTRY.

A genus of the family ORTHOMYXOVIRIDAE comprising viruses similar to types A and B but less common, more stable, more homogeneous, and lacking the neuraminidase protein. They have not been associated with epidemics but may cause mild influenza. Influenza C virus is the type species.

A genus in the family ORTHOMYXOVIRIDAE causing influenza and other diseases in humans and animals. It contains many strains as well as antigenic subtypes of the integral membrane proteins hemagglutinin (HEMAGGLUTININS) and NEURAMINIDASE. The type species is INFLUENZA A VIRUS.

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