A Study to Evaluate the Efficacy and Safety of Intravenous Peramivir in Subjects With Uncomplicated Influenza.
NCT ID: NCT01224795
Last Updated: 2015-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
1 participants
INTERVENTIONAL
2010-10-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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
Placebo Peramivir, administered intravenously.
Placebo Comparator
Placebo Peramivir, administered intravenously.
Interventions
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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 Peramivir, administered intravenously.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
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Department of Health and Human Services
FED
BioCryst Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
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
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
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
Salt Lake City, Utah, United States
South Jordan, Utah, United States
West Jordan, Utah, United States
Arlington, Virginia, United States
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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HHS 0100200700032C
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BCX1812-304
Identifier Type: -
Identifier Source: org_study_id
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