Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza

Phase

Condition

Acute Rhinitis

Chronic Pain

Pain

Treatment

N/A

Clinical Study ID

NCT00957996

BCX1812-303

HHS 0100200700032C

Ages > 6
All Genders

Study Summary

This is a Phase 3, open-label, randomized study of the antiviral activity, safety, and tolerability of intravenous Peramivir in hospitalized subjects with confirmed or suspected influenza infection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Male and non-pregnant female subjects 6 years of age or older.
Able to provide written informed consent, or for whom written consent may be providedby a parent guardian or legally authorized representative, unless consent provided bya parent, guardian or legally authorized representative is not consistent withapplicable local or ethical procedures, directives and /or guidelines.
Presence of clinical signs and/or symptoms consistent with an acute illness compatiblewith influenza infection; a measured temperature of ≥ 38.0°C (100.4°F) oral, or ≥ 38.6°C (101.4°F) rectal or tympanic and recent onset of at least one of the following:rhinorrhea or nasal congestion, sore throat or cough. Measured temperature can includefever meeting the above criteria as reported by the subject or their parent, guardianor legally authorized representative in the 24 hours prior to Screening. Therequirement for fever is waived for any subject with influenza infection alreadyconfirmed by laboratory tests (including Rapid Antigen Tests).
Confirmation of influenza A or B infection in the local community by one of thefollowing means:
the institution's local laboratory,
the local public health system
the national public health system
a laboratory of a recognized national or multinational influenza surveillance scheme.
Severity of illness requiring or anticipated to require in-hospital care.

Exclusion

Exclusion Criteria:

Subjects who have been hospitalized for greater than 24 hours (not including timespent in the emergency department).Blood platelet count of < 20 x 109/L.
Serum bilirubin > 6 mg/dL at time of Screening evaluation.
Serum ALT or AST > 5 X upper limit of normal at time of Screening evaluation.
Serum creatinine > 5.0 mg/dL at time of Screening evaluation.
Subjects who require peritoneal dialysis or hemofiltration.
Altered neurologic status as defined by a Glasgow Coma Score of ≤ 9, unless medicallyinduced.
Females who are pregnant (positive urine or serum pregnancy test at Screeningevaluation) or breastfeeding.
Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. (Subjects who have completed treatment 30 days prior to enrollment are allowed toenroll in the study. Hormone treatment for cancer is also acceptable).
Prior hematopoietic stem cell transplantation or solid organ transplant during theprevious 4 months.
HIV infection with a known CD4 count < 200 cells/ mm3 unless on a stable highly activeantiretroviral (HAART) regimen for at least 6 months.
Presence of a preexisting chronic infection that is undergoing or requiring medicaltherapy (eg, tuberculosis). (Subjects with chronic osteomyelitis or hepatitis B or Cnot requiring treatment are not excluded).
Presence of any preexisting illness that, in the opinion of the Investigator, wouldplace the subject at an unreasonably increased risk through participation in thisstudy.
Participation as a subject in any study of an experimental treatment for any conditionwithin the 30 days prior to the time of the Screening evaluation.
Subjects diagnosed with cystic fibrosis.
Subjects with confirmed clinical evidence of acute non-influenzal infection at thetime of Screening.

Study Design

October 01, 2009

August 31, 2011

Connect with a study center

Brisbane, Queensland
Australia
Site Not Available
Cairns, Queensland
Australia
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Southport, Queensland
Australia
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Clayton, Victoria
Australia
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Melbourne, Victoria
Australia
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Parkville, Victoria
Australia
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Kelowna, British Columbia
Canada
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Winnipeg, Manitoba
Canada
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Hamilton, Ontario
Canada
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Kingston, Ontario
Canada
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Ottawa, Ontario
Canada
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Toronto, Ontario
Canada
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Chicoutimi, Quebec
Canada
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Montréal, Quebec
Canada
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Sainte-Foy, Quebec
Canada
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Sherbrooke, Quebec
Canada
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Trois-Rivieres, Quebec
Canada
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Saskatoon, Saskatchewan
Canada
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Edmonton,
Canada
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Aguascalientes, AGS
Mexico
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Distrito Federal, DF
Mexico
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Guadalajara, JAL
Mexico
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Zapopan, JAL
Mexico
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Monterrey, NL
Mexico
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San Luis Potosi, SLP
Mexico
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Durango,
Mexico
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Auckland, Wellington
New Zealand
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Christchurch,
New Zealand
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Hamilton,
New Zealand
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Tauranga,
New Zealand
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San Juan,
Puerto Rico
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Dothan, Alabama
United States
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Mobile, Alabama
United States
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Jonesboro, Arkansas
United States
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Little Rock, Arkansas
United States
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Fountain Valley, California
United States
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Harbor City, California
United States
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La Mesa, California
United States
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Long Beach, California
United States
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Los Angeles, California
United States
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Modesto, California
United States
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Oceanside, California
United States
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Orange, California
United States
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Palo Alto, California
United States
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Sacramento, California
United States
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San Diego, California
United States
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San Francisco, California
United States
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San Jose, California
United States
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Denver, Colorado
United States
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Wheat Ridge, Colorado
United States
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Washington, District of Columbia
United States
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Brandon, Florida
United States
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Ft. Lauderdale, Florida
United States
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Gainsville, Florida
United States
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Ocoee, Florida
United States
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Orlando, Florida
United States
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West Palm Beach, Florida
United States
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Columbus, Georgia
United States
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Decatur, Georgia
United States
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Honolulu, Hawaii
United States
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Idaho Falls, Idaho
United States
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Chicago, Illinois
United States
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Rock Island, Illinois
United States
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Springfield, Illinois
United States
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Indianapolis, Indiana
United States
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South Bend, Indiana
United States
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Topeka, Kansas
United States
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Hazard, Kentucky
United States
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Natchitoches, Louisiana
United States
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Shreveport, Louisiana
United States
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Baltimore, Maryland
United States
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Boston, Massachusetts
United States
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Detroit, Michigan
United States
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Royal Oak, Michigan
United States
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Troy, Michigan
United States
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Minneapolis, Minnesota
United States
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St. Louis, Missouri
United States
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Butte, Montana
United States
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Omaha, Nebraska
United States
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Englewood, New Jersey
United States
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Hackensack, New Jersey
United States
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Neptune, New Jersey
United States
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New Brunswick, New Jersey
United States
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Somers Point, New Jersey
United States
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Albuquerque, New Mexico
United States
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Albany, New York
United States
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Bronx, New York
United States
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Brooklyn, New York
United States
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Buffalo, New York
United States
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Jamaica, New York
United States
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New York, New York
United States
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Valhalla, New York
United States
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Akron, Ohio
United States
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Cleveland, Ohio
United States
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Lima, Ohio
United States
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Toledo, Ohio
United States
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Portland, Oregon
United States
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Philadelphia, Pennsylvania
United States
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Providence, Rhode Island
United States
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Charleston, South Carolina
United States
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Sioux Falls, South Dakota
United States
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Houston, Texas
United States
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San Antonio, Texas
United States
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Tomball, Texas
United States
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Salt Lake City, Utah
United States
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Norfolk, Virginia
United States
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Salem, Virginia
United States
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Bellevue, Washington
United States
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Seattle, Washington
United States
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Milwaukee, Wisconsin
United States
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