Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316
NCT ID: NCT02026349
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
860 participants
INTERVENTIONAL
2014-01-31
2015-03-31
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
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
Placebo
Administered twice daily over 5 consecutive days for a total of 10 doses.
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.
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
Hunstville, Alabama, United States
Hot Springs, Arkansas, United States
Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
Tustin, California, United States
Upland, California, United States
Colorado Springs, Colorado, United States
Hamden, Connecticut, United States
Bradenton, Florida, United States
Brooksville, Florida, United States
Gainesville, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Lakeland Hills, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Saint Cloud, Florida, United States
South Miami, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Snellville, Georgia, United States
Bardstown, Kentucky, United States
Monroe, Louisiana, United States
Opelousas, Louisiana, United States
Flint, Michigan, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Hickory, North Carolina, United States
Morganton, North Carolina, United States
Winston-Salem, North Carolina, United States
Lansdale, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Smithfield, Pennsylvania, United States
Uniontown, Pennsylvania, United States
Gaffney, South Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Simpsonville, South Carolina, United States
Arlington, Texas, United States
Austin, Texas, United States
Carrollton, Texas, United States
Forth Worth, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
South Jordan, Utah, United States
Arlington, Virginia, United States
La Crosse, Wisconsin, United States
Bedford Park, South Australia, Australia
Deurne, Antwerpen, Belgium
Brussels, Brussels Capital, Belgium
Gozée, Hainaut, Belgium
Mont-sur-Marchienne, Hainaut, Belgium
Halen, Limburg, Belgium
Ham, Limburg, Belgium
Chenée, Liège, Belgium
Deurne, , Belgium
Gribomont, , Belgium
Linkebeek, , Belgium
Gabrovo, Gabrovo, Bulgaria
Haskovo, Haskovo, Bulgaria
Plovdiv, Plovdiv, Bulgaria
Smolyan, Smolyan, Bulgaria
Sofia, Sofia-Grad, Bulgaria
Varna, Varna, Bulgaria
Veliko Tarnovo, Veliko Tarnovo, Bulgaria
Burgas, , Bulgaria
Burgas, , Bulgaria
Gabrovo, , Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Rousse, , Bulgaria
Samokov, , Bulgaria
Sevlievo, , Bulgaria
Sliven, , Bulgaria
Smolyan, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Veliko Tarnovo, , Bulgaria
Balassagyarmat, , Hungary
Budapest, , Hungary
Csongrád, , Hungary
Debrecen, , Hungary
Gödöllő, , Hungary
Gyula, , Hungary
Nyíregyháza, , Hungary
Zalaegerszeg, , Hungary
Nijverdal, Overijssel, Netherlands
Hoogvliet, South Holland, Netherlands
Lieshout, , Netherlands
Nijverdal, , Netherlands
Rotterdam, , Netherlands
The Hague, , Netherlands
Zwijndrecht, , Netherlands
Auckland, North Island, New Zealand
Christchurch, South Island, New Zealand
Hamilton, Waikato Region, New Zealand
Tauranga, , New Zealand
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Tarnów, Lesser Poland Voivodeship, Poland
Oleśnica, Lower Silesian Voivodeship, Poland
Wroclaw, Lower Silesian Voivodeship, Poland
Wroclaw, Lower Silesian Voivodeship, Poland
Świdnik, Lublin Voivodeship, Poland
Lodz, Lódzkie, Poland
Zgierz, Lódzkie, Poland
Łosice, Masovian Voivodeship, Poland
Dębica, Podkarpackie Voivodeship, Poland
Rzeszów, Podkarpackie Voivodeship, Poland
Katowice, Silesian Voivodeship, Poland
Katowice, Silesian Voivodeship, Poland
Katowice, , Poland
Katowice, , Poland
Krakow, , Poland
Krakow, , Poland
Lódz, , Poland
Ostróda, , Poland
Oświęcim, , Poland
Arkangelsk, , Russia
Kazan', , Russia
Moscow, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Tomsk, , Russia
Vladimir, , Russia
Yaroslavl, , Russia
Bloemfontein, Free State, South Africa
Bryanston, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Sophiatown, Johannesburg, Gauteng, South Africa
Soweto, Gauteng, South Africa
Dundee, KwaZulu-Natal, South Africa
eManzimtoti, KwaZulu-Natal, South Africa
Middelburg, Mpumalanga, South Africa
Witbank, Mpumalanga, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Paarl, Western Cape, South Africa
Worcester, Western Cape, South Africa
Cape Town, , South Africa
Durban, , South Africa
eMkhomazi, , South Africa
Johannesburg, , South Africa
Krugersdorp, , South Africa
Potchefstroom, , South Africa
Pretoria, , South Africa
Sophiatown, Johannesburg, , South Africa
Welkom, , South Africa
Alicante, Alicante, Spain
Benidorm, Alicante, Spain
Orihuela, Alicante, Spain
Badalona, Barcelona, Spain
Barcelona, Barcelona, Spain
Castellon, Castellón, Spain
Barcelona, Catalonia, Spain
Llançà, Girona, Spain
Tarragona, Tarragona, Spain
Barcelona, , Spain
Barcelona, , Spain
Malmo, Skåne County, Sweden
Stockholm, Södermanland County, Sweden
Stockholm, Södermanland County, Sweden
Uppsala, Uppsala Ian, Sweden
Gothenburg, Västra Götaland County, Sweden
Karlskrona, , Sweden
Linköping, , Sweden
Malmo, , Sweden
Uppsala, , Sweden
Diyarbakır, Diyarbakır, Turkey (Türkiye)
Izmir, İzmir, Turkey (Türkiye)
Konya, Konya, Turkey (Türkiye)
Trabzon, Trabzon, Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Düzce, , Turkey (Türkiye)
Erzurum, , Turkey (Türkiye)
Eskişehir, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Samsun, , Turkey (Türkiye)
Chernivtsi, Chernivtsi Oblast, Ukraine
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Kyiv, Kyïvs'ka Oblast, Ukraine
Kyiv, Kyïv, Ukraine
Odesa, Odesa Oblast, Ukraine
Odesa, Odesa Oblast, Ukraine
Ternopil, Ternopil Oblast, Ukraine
Vinnytsia, Vinnytsia Oblast, Ukraine
Kharkiv, , Ukraine
Kherson, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Poltava, , Ukraine
Sumy, , Ukraine
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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2013-002149-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
T705US316
Identifier Type: -
Identifier Source: org_study_id
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