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

NCT01224795 | Terminated Phase 3 DMC

• 2 other identifiers: BCX1812-304HHS 0100200700032C
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 96

Brief 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.

Conditions

Influenza

Keywords

uncomplicated influenza

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To evaluate the safety and tolerability of peramivir administered intravenously

  14 Days

Study Arms (2)

Peramivir

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo Peramivir, administered intravenously.

Drug: Placebo Comparator

Interventions

Peramivir DRUG

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

Placebo Comparator DRUG

Placebo Peramivir, administered intravenously.

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioCryst Pharmaceuticals: lead
• Department of Health and Human Services: collaborator

Study Sites (96)

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Birmingham, Alabama, United States

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Hot Springs, Arkansas, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Mountain Home, Arkansas, United States

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Anaheim, California, United States

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Buena Park, California, United States

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Chino, California, United States

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Dinuba, California, United States

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Garden Grove, California, United States

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Lincoln, California, United States

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Los Angeles, California, United States

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Oceanside, California, United States

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Palm Springs, California, United States

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Port Hueneme, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Tustin, California, United States

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West Covina, California, United States

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Boulder, Colorado, United States

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Centennial, Colorado, United States

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Wheat Ridge, Colorado, United States

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Milford, Connecticut, United States

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Brooksville, Florida, United States

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Coral Gables, Florida, United States

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Cutler Bay, Florida, United States

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Daytona Beach, Florida, United States

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Edgewater, Florida, United States

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Gainsville, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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South Miami, Florida, United States

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West Palm Beach, Florida, United States

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Stockbridge, Georgia, United States

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Boise, Idaho, United States

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Aurora, Illinois, United States

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Bloomingdale, Illinois, United States

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Chicago, Illinois, United States

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Peoria, Illinois, United States

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South Bend, Indiana, United States

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Dubuque, Iowa, United States

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Arkansas City, Kansas, United States

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Lenexa, Kansas, United States

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Bardstown, Kentucky, United States

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Hazard, Kentucky, United States

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Paducah, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Shreveport, Louisiana, United States

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Bangor, Maine, United States

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Hollywood, Maryland, United States

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Rockville, Maryland, United States

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Brockton, Massachusetts, United States

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Fall River, Massachusetts, United States

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Washington, Missouri, United States

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Bozeman, Montana, United States

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Fremont, Nebraska, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Albuquerque, New Mexico, United States

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Camillus, New York, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Akron, Ohio, United States

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Dayton, Ohio, United States

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Wadsworth, Ohio, United States

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Owasso, Oklahoma, United States

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Bend, Oregon, United States

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Medford, Oregon, United States

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Hatfield, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Scotland, Pennsylvania, United States

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Cranston, Rhode Island, United States

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Cumberland, Rhode Island, United States

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Johnston, Rhode Island, United States

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Easley, South Carolina, United States

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Greenville, South Carolina, United States

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Bristol, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Bryan, Texas, United States

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Dallas, Texas, United States

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Forth Worth, Texas, United States

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Georgetown, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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North Richland Hills, Texas, United States

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San Antonio, Texas, United States

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Spring, Texas, United States

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Salt Lake City, Utah, United States

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South Jordan, Utah, United States

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West Jordan, Utah, United States

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Arlington, Virginia, United States

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Charlottesville, Virginia, United States

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MeSH Terms

Conditions

Influenza, Human

Interventions

peramivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 20, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 6, 2015

Record last verified: 2014-12

Locations

US (96)