Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults

Completed · Phase 3 · Has a placebo group

Conditions studied: Influenza

In brief

The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.

Key facts

Study ID

NCT02008344

Run by

MDVI, LLC

People needed

1161

Starts

2013-12-01

Expected to finish

2015-01-01

Last updated by the study team

2015-11-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At time of enrollment has 2 or more of the following symptoms (moderate to severe in intensity) that began 48 hours or less prior to the anticipated start of dosing with study medication: cough, sore throat, headache, nasal congestion, body aches and pains, fatigue
• 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

You may not qualify if…

• Female subjects who are pregnant, currently breast-feeding, or have a positive pregnancy test at Screening
• 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)

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Camp Verde, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Carmichael, California, United States
• Study site — Chula Vista, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Fresno, California, United States
• Study site — Garden Grove, California, United States
• Study site — Gold River, California, United States
• Study site — Harbor City, California, United States
• Study site — La Mesa, California, United States
• Study site — Lomita, California, United States
• Study site — Los Angeles, California, United States
• Study site — Modesto, California, United States
• Study site — North Hollywood, California, United States
• Study site — Northridge, California, United States
• Study site — Oceanside, California, United States
• Study site — Paramount, California, United States
• Study site — Roseville, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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