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

NCT00957996 | Completed Phase 3 Results DMC

• 2 other identifiers: BCX1812-303HHS 0100200700032C
• Study Type: interventional
• Target: 234
• Locations: 6 countries
• Sites: 110

Brief 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.

Conditions

Seasonal Influenza; Cough; Sore Throat; Nasal Congestion; Myalgia; Headache; Fatigue

Keywords

influenza; hospitalized; flu; antiviral

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Influenza Virus Titer (48 Hours)

  The time-weighted change from baseline in log10 tissue culture infective dose50 (TCID50/mL) was calculated on a by-subject basis through 48 hours using the trapezoidal rule with all available data minus the baseline value. Ninety-five percent confidence intervals about the median time-weighted change from baseline were presented for each treatment group.

  Baseline and 48 hours

Secondary Outcomes (11)

• Change in Influenza Virus Titer, as Measured by Quantitative RT-PCR (log10 vp/mL)

  Baseline, 48, 108, 216 hours

• Time to Clinical Resolution

  28 days

• Number of Participants With Clinical Resolution

  28 days

• Time to Alleviation of Symptoms

  28 days

• Time to Resolution of Fever

  28 days

Other Outcomes (1)

• Number of Participants Who Required More Than 5 Days of Peramivir Treatment

  28 days

Study Arms (2)

Peramivir 300 mg

EXPERIMENTAL

Peramivir 300 mg twice daily

Drug: Peramivir

Peramivir 600 mg

EXPERIMENTAL

Peramivir 600 mg once daily

Drug: Peramivir

Interventions

Peramivir DRUG

300 mg twice daily

Peramivir 300 mg

Eligibility Criteria

• Age: 6 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 6 years of age or older.
• 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.

You may not qualify if:

• Subjects who have been hospitalized for greater than 24 hours (not including time spent 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 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.

Sponsors & Collaborators

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

Study Sites (110)

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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 D.C., District of Columbia, United States

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Brandon, Florida, United States

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Fort 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 City, 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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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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The Bronx, 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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Brisbane, Queensland, Australia

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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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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Edmonton, Canada

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Aguascalientes, Aguascalientes, Mexico

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Guadalajara, Jalisco, Mexico

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Zapopan, Jalisco, Mexico

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Distrito Federal, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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San Luis Potosí City, San Luis Potosí, Mexico

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Durango, Mexico

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Auckland, Wellington Region, 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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Related Publications (1)

• 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.

  PMID: 23985625 DERIVED

MeSH Terms

Conditions

Cough; Pharyngitis; Nasal Obstruction; Myalgia; Headache; Fatigue; Influenza, Human

Interventions

peramivir

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Results Point of Contact

• Title: William P. Sheridan, MBBS
• Organization: BioCryst Pharmaceuticals, Inc.

919-859-1302

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: August 1, 2011
• Last Updated: February 12, 2015
• Results First Posted: February 12, 2015

Record last verified: 2015-01

Locations

ME (7); PR (1); NZ (4); CA (13); US (79); AU (6)