This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been terminated.
(This study was terminated for administrative reasons)
Department of Health and Human Services
Information provided by (Responsible Party):
BioCryst Pharmaceuticals Identifier:
First received: October 19, 2010
Last updated: December 15, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Influenza Drug: Peramivir Drug: Placebo Comparator Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by BioCryst Pharmaceuticals:

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

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of peramivir administered intravenously [ Time Frame: 14 Days ]

    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.

Enrollment: 1
Study Start Date: October 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01224795

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arkansas
Hot Springs, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Mountain Home, Arkansas, United States
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
United States, Colorado
Boulder, Colorado, United States
Centennial, Colorado, United States
Wheat Ridge, Colorado, United States
United States, Connecticut
Milford, Connecticut, United States
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
United States, Georgia
Stockbridge, Georgia, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Aurora, Illinois, United States
Bloomingdale, Illinois, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
United States, Indiana
South Bend, Indiana, United States
United States, Iowa
Dubuque, Iowa, United States
United States, Kansas
Arkansas City, Kansas, United States
Lenexa, Kansas, United States
United States, Kentucky
Bardstown, Kentucky, United States
Hazard, Kentucky, United States
Paducah, Kentucky, United States
United States, Louisiana
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maine
Bangor, Maine, United States
United States, Maryland
Hollywood, Maryland, United States
Rockville, Maryland, United States
United States, Massachusetts
Brockton, Massachusetts, United States
Fall River, Massachusetts, United States
United States, Missouri
Washington, Missouri, United States
United States, Montana
Bozeman, Montana, United States
United States, Nebraska
Fremont, Nebraska, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Camillus, New York, United States
United States, North Carolina
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, North Dakota
Fargo, North Dakota, United States
United States, Ohio
Akron, Ohio, United States
Dayton, Ohio, United States
Wadsworth, Ohio, United States
United States, Oklahoma
Owasso, Oklahoma, United States
United States, Oregon
Bend, Oregon, United States
Medford, Oregon, United States
United States, Pennsylvania
Hatfield, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Scotland, Pennsylvania, United States
United States, Rhode Island
Cranston, Rhode Island, United States
Cumberland, Rhode Island, United States
Johnston, Rhode Island, United States
United States, South Carolina
Easley, South Carolina, United States
Greenville, South Carolina, United States
United States, Tennessee
Bristol, Tennessee, United States
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
United States, Utah
Salt Lake City, Utah, United States
South Jordan, Utah, United States
West Jordan, Utah, United States
United States, Virginia
Arlington, Virginia, United States
Charlottesville, Virginia, United States
Sponsors and Collaborators
BioCryst Pharmaceuticals
Department of Health and Human Services
  More Information

Responsible Party: BioCryst Pharmaceuticals Identifier: NCT01224795     History of Changes
Other Study ID Numbers: BCX1812-304
HHS 0100200700032C ( Other Grant/Funding Number: HHS-BARDA )
Study First Received: October 19, 2010
Last Updated: December 15, 2014

Keywords provided by BioCryst Pharmaceuticals:
uncomplicated influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on June 22, 2017