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



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:December 2013
End Date:January 2015

Use our guide to learn which trials are right for you!

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza

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

The purpose of this study is to determine if a 5-day regimen of favipiravir reduces the time
to alleviation of influenza symptoms, resolution of fever, and viral shedding, in subjects
with uncomplicated influenza compared to no treatment (e.g. placebo).

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)
We found this trial at
150
sites
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Allen, TX
Click here to add this to my saved trials
?
mi
from
Ashland, OR
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Bardstown, KY
Click here to add this to my saved trials
Belle Vernon, Pennsylvania 15812
?
mi
from
Belle Vernon, PA
Click here to add this to my saved trials
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Bristol, TN
Click here to add this to my saved trials
?
mi
from
Brownsburg, IN
Click here to add this to my saved trials
?
mi
from
Butte, MT
Click here to add this to my saved trials
?
mi
from
Calabash, NC
Click here to add this to my saved trials
?
mi
from
Camp Verde, AZ
Click here to add this to my saved trials
?
mi
from
Carmichael, CA
Click here to add this to my saved trials
?
mi
from
Carrollton, TX
Click here to add this to my saved trials
?
mi
from
Celebration, FL
Click here to add this to my saved trials
?
mi
from
Centennial, CO
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Clairton, PA
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbia, MD
Click here to add this to my saved trials
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
?
mi
from
Cumberland, RI
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Draper, UT
Click here to add this to my saved trials
?
mi
from
Dunwoody, GA
Click here to add this to my saved trials
?
mi
from
Edgewater, FL
Click here to add this to my saved trials
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
?
mi
from
Franklin, TN
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
?
mi
from
Glenwood Springs, CO
Click here to add this to my saved trials
?
mi
from
Gold River, CA
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Greer, SC
Click here to add this to my saved trials
?
mi
from
Harbor City, CA
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hickory, NC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntersville, North Carolina 28078
?
mi
from
Huntersville, NC
Click here to add this to my saved trials
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
?
mi
from
Indiana, PA
Click here to add this to my saved trials
?
mi
from
Jackson, TN
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Kettering, OH
Click here to add this to my saved trials
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
?
mi
from
La Palta,
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33313
?
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
Lexington, North Carolina 27292
?
mi
from
Lexington, NC
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Lodi, NJ
Click here to add this to my saved trials
?
mi
from
Lomita, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Lynn Haven, FL
Click here to add this to my saved trials
Madison Heights, Michigan 48071
?
mi
from
Madison Heights, MI
Click here to add this to my saved trials
?
mi
from
McKinney, TX
Click here to add this to my saved trials
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Missoula, MT
Click here to add this to my saved trials
?
mi
from
Modesto, CA
Click here to add this to my saved trials
?
mi
from
Monroe, LA
Click here to add this to my saved trials
?
mi
from
Morganton, NC
Click here to add this to my saved trials
?
mi
from
Murrells Inlet, SC
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
New Port Richey, FL
Click here to add this to my saved trials
?
mi
from
New Smyrna Beach, FL
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newport News, VA
Click here to add this to my saved trials
?
mi
from
Norcross, GA
Click here to add this to my saved trials
North Hollywood, California 91606
?
mi
from
North Hollywood, CA
Click here to add this to my saved trials
North Myrtle Beach, South Carolina 29582
?
mi
from
North Myrtle Beach, SC
Click here to add this to my saved trials