Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults
NCT ID: NCT02008344
Last Updated: 2015-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1161 participants
INTERVENTIONAL
2013-12-31
2015-01-31
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
QUADRUPLE
Study Groups
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favipiravir
Day 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose)
favipiravir
Administered twice daily over 5 consecutive days for a total of 10 doses.
* Day 1: 1800 mg twice daily (loading doses)
* Days 2 through 5: 800 mg twice daily
placebo
Day 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose)
placebo
Administered twice daily over 5 consecutive days for a total of 10 doses.
* Day 1: 1800 mg twice daily (loading doses)
* Days 2 through 5: 800 mg twice daily
Interventions
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favipiravir
Administered twice daily over 5 consecutive days for a total of 10 doses.
* Day 1: 1800 mg twice daily (loading doses)
* Days 2 through 5: 800 mg twice daily
placebo
Administered twice daily over 5 consecutive days for a total of 10 doses.
* Day 1: 1800 mg twice daily (loading doses)
* Days 2 through 5: 800 mg twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a fever at the first visit or in the 6 hours prior if antipyretics were taken, defined as: ≥ 38.0°C (≥ 100.4°F) if \< 65 years old; or ≥ 37.8°C (≥ 100.0°F) if ≥ 65 years old
* Tests positive for influenza A or B during the 48 hours between onset of symptoms and anticipated dosing with study medication as confirmed by RAT or PCR testing (study or non-study procedure); or per Investigator and Medical Monitor discretion in the event there is a known influenza outbreak circulating in the community or the subject has been in close contact with a person who was recently confirmed to have laboratory-confirmed influenza
* Willing to adhere to strict contraceptive measures throughout study and for 3 months following last dose of study medication
Exclusion Criteria
* Has taken an anti-influenza drug, or received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent
* Has underlying chronic respiratory disease; includes bronchial asthma if currently experience asthma symptoms, requires current asthma treatment, or has had an asthma attack in the past year
* Is suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung observed on chest x ray, or is on antibiotics for pulmonary disease) at start of study
* Has a history of gout or is under treatment for: gout or hyperuricemia; hereditary xanthinuria; hypouricemia or xanthine calculi of the urinary tract
* Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase
* Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs
* Has an allergy or contraindication to use of acetaminophen (paracetamol)
* Has a serious chronic disease, history of alcohol or drug abuse within preceding 2 years, psychiatric illness not well controlled (not on stable regimen \> 1 year), or is deemed by the Investigator to be ineligible for any reason
* Previously participated in a clinical trial of favipiravir (T-705)
* Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
18 Years
80 Years
ALL
No
Sponsors
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MediVector, Inc.
INDUSTRY
MDVI, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Carol Epstein, MD
Role: STUDY_DIRECTOR
MediVector, Inc.
Locations
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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Camp Verde, Arizona, United States
Mesa, Arizona, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Carmichael, California, United States
Chula Vista, California, United States
Fountain Valley, California, United States
Fresno, California, United States
Garden Grove, California, United States
Gold River, California, United States
Harbor City, California, United States
La Mesa, California, United States
Lomita, California, United States
Los Angeles, California, United States
Modesto, California, United States
North Hollywood, California, United States
Northridge, California, United States
Oceanside, California, United States
Paramount, California, United States
Roseville, California, United States
San Diego, California, United States
San Diego, California, United States
San Gabriel, California, United States
Stockton, California, United States
Upland, California, United States
Centennial, Colorado, United States
Colorado Springs, Colorado, United States
Colorado Springs, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Glenwood Springs, Colorado, United States
Waterbury, Connecticut, United States
Celebration, Florida, United States
Clearwater, Florida, United States
Delray Beach, Florida, United States
Edgewater, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Lauderdale Lakes, Florida, United States
Lynn Haven, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
New Smyrna Beach, Florida, United States
Ormond Beach, Florida, United States
Pembroke Pines, Florida, United States
Plantation, Florida, United States
Port Orange, Florida, United States
Saint Cloud, Florida, United States
South Miami, Florida, United States
Summerfield, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Dunwoody, Georgia, United States
Norcross, Georgia, United States
Oakwood, Georgia, United States
Riverdale, Georgia, United States
Snellville, Georgia, United States
Idaho Falls, Idaho, United States
Twin Falls, Idaho, United States
Brownsburg, Indiana, United States
Evansville, Indiana, United States
Wichita, Kansas, United States
Bardstown, Kentucky, United States
Monroe, Louisiana, United States
New Orleans, Louisiana, United States
Opelousas, Louisiana, United States
Columbia, Maryland, United States
Towson, Maryland, United States
Watertown, Massachusetts, United States
Worcester, Massachusetts, United States
Madison Heights, Michigan, United States
Troy, Michigan, United States
St Louis, Missouri, United States
Billings, Montana, United States
Butte, Montana, United States
Missoula, Montana, United States
Bellevue, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Lodi, New Jersey, United States
New York, New York, United States
Calabash, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Huntersville, North Carolina, United States
Lexington, North Carolina, United States
Morganton, North Carolina, United States
Winston-Salem, North Carolina, United States
Kettering, Ohio, United States
Toledo, Ohio, United States
Wadsworth, Ohio, United States
Ashland, Oregon, United States
Belle Vernon, Pennsylvania, United States
Clairton, Pennsylvania, United States
Indiana, Pennsylvania, United States
Scottdale, Pennsylvania, United States
Smithfield, Pennsylvania, United States
Tyrone, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Cumberland, Rhode Island, United States
Greenville, South Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Murrells Inlet, South Carolina, United States
North Myrtle Beach, South Carolina, United States
Rock Hill, South Carolina, United States
Rapid City, South Dakota, United States
Bristol, Tennessee, United States
Franklin, Tennessee, United States
Jackson, Tennessee, United States
Smyrna, Tennessee, United States
Allen, Texas, United States
Carrollton, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
McKinney, Texas, United States
Plano, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Sealy, Texas, United States
Sugar Land, Texas, United States
Victoria, Texas, United States
Draper, Utah, United States
Salt Lake City, Utah, United States
South Jordan, Utah, United States
Newport News, Virginia, United States
Spokane, Washington, United States
La Palta, Buenos Aires, Argentina
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Córdoba, Córdoba Province, Argentina
Córdoba, Córdoba Province, Argentina
Rosario, Santa Fe Province, Argentina
Santa Fe, Santa Fe Province, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Mar del Plata, , Argentina
Ramos Mejía, , Argentina
San Miguel de Tucumán, , Argentina
Vicente López, , Argentina
Belo Horizonte, Minas Gerais, Brazil
Juiz de Fora, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Passo Fundo, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Campinas, São Paulo, Brazil
Santo André, São Paulo, Brazil
Santo André, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Brasília, , Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Mount Pearl, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Burlington, Ontario, Canada
Cambridge, Ontario, Canada
Corunna, Ontario, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Newmarket, Ontario, Canada
Oshawa, Ontario, Canada
Sarnia, Ontario, Canada
Scarborough Village, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Drummondville, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sainte-Foy, Quebec, Canada
Sherbrooke, Quebec, Canada
Victoriaville, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Medellín, Antioquia, Colombia
Bogotá, Cundinamarca, Colombia
Cali, Valle de Cauca, Colombia
Cali, Valle del Cauca Department, Colombia
Medellín, , Colombia
Santo Domingo, National District, Dominican Republic
Santo Domingo, National District, Dominican Republic
Santo Domingo, National District, Dominican Republic
Santa Tecla, La Libertad Department, El Salvador
San Salvador, San Salvador Department, El Salvador
Guatemala City, Departamento de Guatemala, Guatemala
Guatemala City, Departamento de Guatemala, Guatemala
Chihuahua City, Chihuahua, Mexico
León, Guanajanto, Mexico
León, Guanajuato, Mexico
Acapulco de Juárez, Guerrero, Mexico
El Salto, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Distrito Federal, Mexico City, Mexico
Distrito Federal, Mexico City, Mexico
Cuernavaca, Morelos, Mexico
Cuernavaca, Morelos, Mexico
Monterrey, Nuevo León, Mexico
Culiacán, Sinaloa, Mexico
Xalapa, Veracruz, Mexico
Cuautitlán Izcalli, , Mexico
Guanajanto, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Tlalnepantla, , Mexico
Arequipa, Arequipa, Peru
Cusco, Departamento de Cusco, Peru
Ica, Ica, Peru
Trujillo, La Libertad, Peru
Lima, Lima Province, Peru
Lima, Lima Province, Peru
Lima, Lima Province, Peru
Lima, Lima Province, Peru
Lima, Lima Province, Peru
Miraflores, Lima region, Peru
Loreto, Loreto, Peru
Piura, Piura, Peru
Manatí, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Hayden FG, Lenk RP, Stonis L, Oldham-Creamer C, Kang LL, Epstein C. Favipiravir Treatment of Uncomplicated Influenza in Adults: Results of Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Trials. J Infect Dis. 2022 Nov 11;226(10):1790-1799. doi: 10.1093/infdis/jiac135.
Other Identifiers
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U1111-1147-8470
Identifier Type: OTHER
Identifier Source: secondary_id
T705US317
Identifier Type: -
Identifier Source: org_study_id
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