A Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.

A Phase III, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.

This is a study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute uncomplicated influenza.

Study Overview

• Status: Terminated
• Conditions: Influenza
• Intervention / Treatment: Drug: Peramivir; Drug: Placebo Comparator

Detailed Description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single dose of intravenous peramivir versus placebo in adolescents and adults with acute,uncomplicated influenza.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
  • Arkansas
    • Hot Springs, Arkansas, United States
    • Jonesboro, Arkansas, United States
    • Little Rock, Arkansas, United States
    • Mountain Home, Arkansas, United States
  • California
    • Anaheim, California, United States
    • Buena Park, California, United States
    • Chino, California, United States
    • Dinuba, California, United States
    • Garden Grove, California, United States
    • Lincoln, California, United States
    • Los Angeles, California, United States
    • Oceanside, California, United States
    • Palm Springs, California, United States
    • Port Hueneme, California, United States
    • Sacramento, California, United States
    • San Diego, California, United States
    • Tustin, California, United States
    • West Covina, California, United States
  • Colorado
    • Boulder, Colorado, United States
    • Centennial, Colorado, United States
    • Wheat Ridge, Colorado, United States
  • Connecticut
    • Milford, Connecticut, United States
  • Florida
    • Brooksville, Florida, United States
    • Coral Gables, Florida, United States
    • Cutler Bay, Florida, United States
    • Daytona Beach, Florida, United States
    • Edgewater, Florida, United States
    • Gainsville, Florida, United States
    • Hialeah, Florida, United States
    • Jacksonville, Florida, United States
    • Miami, Florida, United States
    • South Miami, Florida, United States
    • West Palm Beach, Florida, United States
  • Georgia
    • Stockbridge, Georgia, United States
  • Idaho
    • Boise, Idaho, United States
  • Illinois
    • Aurora, Illinois, United States
    • Bloomingdale, Illinois, United States
    • Chicago, Illinois, United States
    • Peoria, Illinois, United States
  • Indiana
    • South Bend, Indiana, United States
  • Iowa
    • Dubuque, Iowa, United States
  • Kansas
    • Arkansas City, Kansas, United States
    • Lenexa, Kansas, United States
  • Kentucky
    • Bardstown, Kentucky, United States
    • Hazard, Kentucky, United States
    • Paducah, Kentucky, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
    • Shreveport, Louisiana, United States
  • Maine
    • Bangor, Maine, United States
  • Maryland
    • Hollywood, Maryland, United States
    • Rockville, Maryland, United States
  • Massachusetts
    • Brockton, Massachusetts, United States
    • Fall River, Massachusetts, United States
  • Missouri
    • Washington, Missouri, United States
  • Montana
    • Bozeman, Montana, United States
  • Nebraska
    • Fremont, Nebraska, United States
    • Lincoln, Nebraska, United States
    • Omaha, Nebraska, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • Camillus, New York, United States
  • North Carolina
    • Raleigh, North Carolina, United States
    • Winston-Salem, North Carolina, United States
  • North Dakota
    • Fargo, North Dakota, United States
  • Ohio
    • Akron, Ohio, United States
    • Dayton, Ohio, United States
    • Wadsworth, Ohio, United States
  • Oklahoma
    • Owasso, Oklahoma, United States
  • Oregon
    • Bend, Oregon, United States
    • Medford, Oregon, United States
  • Pennsylvania
    • Hatfield, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States
    • Scotland, Pennsylvania, United States
  • Rhode Island
    • Cranston, Rhode Island, United States
    • Cumberland, Rhode Island, United States
    • Johnston, Rhode Island, United States
  • South Carolina
    • Easley, South Carolina, United States
    • Greenville, South Carolina, United States
  • Tennessee
    • Bristol, Tennessee, United States
  • Texas
    • Arlington, Texas, United States
    • Austin, Texas, United States
    • Beaumont, Texas, United States
    • Bryan, Texas, United States
    • Dallas, Texas, United States
    • Forth Worth, Texas, United States
    • Georgetown, Texas, United States
    • Houston, Texas, United States
    • Lake Jackson, Texas, United States
    • North Richland Hills, Texas, United States
    • San Antonio, Texas, United States
    • Spring, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
    • South Jordan, Utah, United States
    • West Jordan, Utah, United States
  • Virginia
    • Arlington, Virginia, United States
    • Charlottesville, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and non-pregnant female subjects age ≥12 years.
• Test positive for influenza A or B by Rapid Antigen Test (RAT) performed with a commercially available test on an adequate anterior nasal specimen in accordance with the manufacturer's instructions.
• Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of at least moderate severity.
• Presence of at least one constitutional symptom (myalgia [aches and pains], headache,feverishness, or fatigue) of at least moderate severity.
• Onset of symptoms no more than 36 hours before presentation for screening.
• Written informed consent/assent.

Exclusion Criteria:

• Women who are pregnant or breast-feeding.
• Employees of the study site, or immediate family members of study site employees.
• Presence of clinically significant signs of acute respiratory distress.
• History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma.
• History of heart failure or angina requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class III or IV functional status within the past 12 months.
• History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min).
• Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the investigator's opinion, indicates that such finding(s) could represent complications of influenza.
• Current clinical evidence, including clinical signs and/or symptoms consistent with otitis media,bronchitis, sinusitis and/or pneumonia, or active bacterial infection of any body site that requires therapy with oral or systemic antibiotics.
• Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy which would include oral or systemic treatment with > 10 mg ic treatment with > 10 mg prednisone or equivalent on a daily basis within 30 days of screening.
• Presence of known HIV infection with a CD4 count <350 cell/mm3.
• Receipt of any dose of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening.
• Immunization against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days.
• History of alcohol abuse or drug addiction within 1 year prior to admission in the study.
• Participation in a previous study of intramuscular or intravenous peramivir, or previous exposure to peramivir.
• Participation in a study of any investigational drug or device within the last 30 days.
• Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
• Presence of any pre-existing illness that in the opinion of the investigator would make the subject unable to comply with the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Peramivir; Adults (≥ 18 years): Peramivir 600 mg, administered intravenously. Adolescents (12 to < 18 years): Peramivir 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously.	Drug: Peramivir; Adults (≥ 18 years): Peramivir 600 mg, administered intravenously. Adolescents (12 to < 18 years): Peramivir 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously.
PLACEBO_COMPARATOR: Placebo; Placebo Peramivir, administered intravenously.	Drug: Placebo Comparator; Placebo Peramivir, administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of peramivir administered intravenously compared to placebo on the time to alleviation of clinical symptoms with acute uncomplicated influenza.	Time to alleviation of clinical symptoms in adolescents and adults with uncomplicated acute influenza measured from patient reported study diaries.	14 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of peramivir administered intravenously	To evaluate time to resolution of fever in response to treatment. To evaluate changes in influenza virus titer in nasal and pharyngeal samples (viral shedding) in response to treatment. To evaluate secondary clinical outcomes and changes in virus susceptibility to neuraminidase inhibitors in response to treatment.	14 Days

Collaborators and Investigators

• Sponsor: BioCryst Pharmaceuticals
• Collaborators: Department of Health and Human Services

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): November 1, 2010

Study Registration Dates

• First Submitted: October 19, 2010
• First Submitted That Met QC Criteria: October 19, 2010
• First Posted (ESTIMATE): October 20, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 6, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: uncomplicated influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Peramivir
• Other Study ID Numbers: BCX1812-304; HHS 0100200700032C (Other Grant/Funding Number: HHS-BARDA)