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WITHDRAWN

NCT01224795

PHASE3

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

Sponsor: BioCryst Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2010-10

Completion Date

2010-11

Last Updated

2026-06-10

Healthy Volunteers

Conditions

Influenza

Interventions

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.

DRUG

Placebo Comparator

Placebo Peramivir, administered intravenously.

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.

Locations (96)

Birmingham, Alabama, United States

Hot Springs, Arkansas, United States

Jonesboro, Arkansas, United States

Little Rock, Arkansas, United States

Mountain Home, Arkansas, United States

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

Boulder, Colorado, United States

Centennial, Colorado, United States

Wheat Ridge, Colorado, United States

Milford, Connecticut, United States

Brooksville, Florida, United States

Coral Gables, Florida, United States

Cutler Bay, Florida, United States

Daytona Beach, Florida, United States

Edgewater, Florida, United States

Gainesville, 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

Stockbridge, Georgia, United States

Boise, Idaho, United States

Aurora, Illinois, United States

Bloomingdale, Illinois, United States

Chicago, Illinois, United States

Peoria, Illinois, United States

South Bend, Indiana, United States

Dubuque, Iowa, United States

Arkansas City, Kansas, United States

Lenexa, Kansas, United States

Bardstown, Kentucky, United States

Hazard, Kentucky, United States

Paducah, Kentucky, United States

Baton Rouge, Louisiana, United States

Shreveport, Louisiana, United States

Bangor, Maine, United States

Hollywood, Maryland, United States

Rockville, Maryland, United States

Brockton, Massachusetts, United States

Fall River, Massachusetts, United States

Washington, Missouri, United States

Bozeman, Montana, United States

Fremont, Nebraska, United States

Lincoln, Nebraska, United States

Omaha, Nebraska, United States

Albuquerque, New Mexico, United States

Camillus, New York, United States

Raleigh, North Carolina, United States

Winston-Salem, North Carolina, United States

Fargo, North Dakota, United States

Akron, Ohio, United States

Dayton, Ohio, United States

Wadsworth, Ohio, United States

Owasso, Oklahoma, United States

Bend, Oregon, United States

Medford, Oregon, United States

Hatfield, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Scotland, Pennsylvania, United States

Cranston, Rhode Island, United States

Cumberland, Rhode Island, United States

Johnston, Rhode Island, United States

Easley, South Carolina, United States

Greenville, South Carolina, United States

Bristol, Tennessee, United States

Arlington, Texas, United States

Austin, Texas, United States

Beaumont, Texas, United States

Bryan, Texas, United States

Dallas, Texas, United States

Fort 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

Salt Lake City, Utah, United States

South Jordan, Utah, United States

West Jordan, Utah, United States

Arlington, Virginia, United States

Charlottesville, Virginia, United States