Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza
NCT ID: NCT00957996
Last Updated: 2015-02-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
234 participants
INTERVENTIONAL
2009-10-31
2011-08-31
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
NONE
Study Groups
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Peramivir 300 mg
Peramivir 300 mg twice daily
Peramivir
300 mg twice daily
Peramivir 600 mg
Peramivir 600 mg once daily
Peramivir
600 mg once daily
Interventions
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Peramivir
300 mg twice daily
Peramivir
600 mg once daily
Eligibility Criteria
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Inclusion Criteria
* Able to provide written informed consent, or for whom written consent may be provided by a parent guardian or legally authorized representative, unless consent provided by a parent, guardian or legally authorized representative is not consistent with applicable local or ethical procedures, directives and /or guidelines.
* Presence of clinical signs and/or symptoms consistent with an acute illness compatible with 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 include fever meeting the above criteria as reported by the subject or their parent, guardian or legally authorized representative in the 24 hours prior to Screening. The requirement for fever is waived for any subject with influenza infection already confirmed by laboratory tests (including Rapid Antigen Tests).
* Confirmation of influenza A or B infection in the local community by one of the following 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 Criteria
* 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 medically induced.
* Females who are pregnant (positive urine or serum pregnancy test at Screening evaluation) or breastfeeding.
* Actively undergoing systemic chemotherapy or radiotherapy treatment for a malignancy. (Subjects who have completed treatment 30 days prior to enrollment are allowed to enroll in the study. Hormone treatment for cancer is also acceptable).
* Prior hematopoietic stem cell transplantation or solid organ transplant during the previous 4 months.
* HIV infection with a known CD4 count \< 200 cells/ mm3 unless on a stable highly active antiretroviral (HAART) regimen for at least 6 months.
* Presence of a preexisting chronic infection that is undergoing or requiring medical therapy (eg, tuberculosis). (Subjects with chronic osteomyelitis or hepatitis B or C not requiring treatment are not excluded).
* Presence of any preexisting illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study.
* Participation as a subject in any study of an experimental treatment for any condition within 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 the time of Screening.
6 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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Dothan, Alabama, United States
Mobile, Alabama, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Fountain Valley, California, United States
Harbor City, California, United States
La Mesa, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Modesto, California, United States
Oceanside, California, United States
Orange, California, United States
Palo Alto, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
San Jose, California, United States
Denver, Colorado, United States
Wheat Ridge, Colorado, United States
Washington D.C., District of Columbia, United States
Brandon, Florida, United States
Fort Lauderdale, Florida, United States
Gainsville, Florida, United States
Ocoee, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Columbus, Georgia, United States
Decatur, Georgia, United States
Honolulu, Hawaii, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Rock Island, Illinois, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
South Bend, Indiana, United States
Topeka, Kansas, United States
Hazard, Kentucky, United States
Natchitoches, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Royal Oak, Michigan, United States
Troy, Michigan, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Butte, Montana, United States
Omaha, Nebraska, United States
Englewood, New Jersey, United States
Hackensack, New Jersey, United States
Neptune City, New Jersey, United States
New Brunswick, New Jersey, United States
Somers Point, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Brooklyn, New York, United States
Buffalo, New York, United States
Jamaica, New York, United States
New York, New York, United States
The Bronx, New York, United States
Valhalla, New York, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Lima, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Sioux Falls, South Dakota, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Salem, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Brisbane, Queensland, Australia
Cairns, Queensland, Australia
Southport, Queensland, Australia
Clayton, Victoria, Australia
Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Kelowna, British Columbia, Canada
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois-Rivières, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Edmonton, , Canada
Aguascalientes, Aguascalientes, Mexico
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Distrito Federal, Mexico City, Mexico
Monterrey, Nuevo León, Mexico
San Luis Potosí City, San Luis Potosí, Mexico
Durango, , Mexico
Auckland, Wellington Region, New Zealand
Christchurch, , New Zealand
Hamilton, , New Zealand
Tauranga, , New Zealand
San Juan, , Puerto Rico
Countries
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References
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Ison MG, Fraiz J, Heller B, Jauregui L, Mills G, O'Riordan W, O'Neil B, Playford EG, Rolf JD, Sada-Diaz E, Elder J, Collis P, Hernandez JE, Sheridan WP. Intravenous peramivir for treatment of influenza in hospitalized patients. Antivir Ther. 2014;19(4):349-61. doi: 10.3851/IMP2680. Epub 2013 Aug 28.
Other Identifiers
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HHS 0100200700032C
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BCX1812-303
Identifier Type: -
Identifier Source: org_study_id
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