Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:20 - 80
Updated:4/21/2016
Start Date:February 2010
End Date:May 2012

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Favipiravir in Adult Patients With Uncomplicated Influenza

This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating
the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated
influenza.

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed
to evaluate the efficacy and safety of a 5-day regimen of favipiravir in influenza patients
aged 20-80 years. Enrolled patients will be randomly assigned to 1 of 3 parallel treatment
dose groups:Placebo; Low-dose favipiravir (1000 mg favipiravir BID for 1 day, followed by
400 mg favipiravir BID for 4 days); High-dose favipiravir (1200 mg favipiravir BID for 1
day, followed by 800 mg favipiravir BID for 4 days).

Inclusion Criteria:

1. Patients who test positive for influenza A or B by a commercially available Rapid
Antigen Test (RAT) of the nasopharynx. A patient with a negative RAT result may still
enroll if the sponsor and investigator agree that there is a known influenza outbreak
circulating in the community.

2. Patients ≥ 20 but < 65 years of age with a temperature (oral) of 100.4°F (38.0°C) or
more; patients ≥ 65 years of age with a temperature (oral) of 100.0°F (37.8°C) or
more at the first visit, or in the 6 hours prior if antipyretics were taken.

3. Patients with 2 or more of the following symptoms (moderate to severe in intensity)
at the time of enrollment:

- Cough

- Sore throat

- Headache

- Nasal congestion

- Feeling feverish

- Body aches and pains

- Fatigue (tiredness)

Exclusion Criteria:

1. Patients who have had influenza symptoms or fever (i.e., one of the symptoms listed
under the inclusion criteria) for 36 hours or more prior to study screening.

2. Patients who have underlying chronic respiratory disease (e.g., chronic obstructive
pulmonary disease [COPD], chronic bronchitis, diffuse panbronchiolitis,
bronchiectasis, pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or old
tuberculosis).

3. Patients who at the beginning of the study are suspected of having bacterial
respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or
infiltrate in lung in a chest x-ray, etc.).

4. Patients who have serious chronic diseases. For example, patients with HIV, cancer
(i.e., requiring chemotherapy within the preceding 6 months), cirrhosis (end-stage),
and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic
disease states requiring medication dose adjustments within the last 30 days.
We found this trial at
122
sites
711
mi
from 43215
Gainesville, FL
Click here to add this to my saved trials
798
mi
from 43215
Alexandria, LA
Click here to add this to my saved trials
329
mi
from 43215
Alexandria, VA
Click here to add this to my saved trials
1078
mi
from 43215
Amarillo, TX
Click here to add this to my saved trials
1962
mi
from 43215
Anaheim, CA
Click here to add this to my saved trials
933
mi
from 43215
Arlington, TX
Click here to add this to my saved trials
1069
mi
from 43215
Austin, TX
Click here to add this to my saved trials
801
mi
from 43215
Baton Rouge, LA
Click here to add this to my saved trials
925
mi
from 43215
Beaumont, TX
Click here to add this to my saved trials
679
mi
from 43215
Bellevue, NE
Click here to add this to my saved trials
492
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
216 Blacktown Road
Blacktown, New South Wales 2756
9469
mi
from 43215
Blacktown,
Click here to add this to my saved trials
955
mi
from 43215
Boca Raton, FL
Click here to add this to my saved trials
1714
mi
from 43215
Boise, ID
Click here to add this to my saved trials
943
mi
from 43215
Boynton Beach, FL
Click here to add this to my saved trials
522
mi
from 43215
Bridgeport, CT
Click here to add this to my saved trials
156
mi
from 43215
Bridgeville, PA
Click here to add this to my saved trials
478
mi
from 43215
Brooklyn, NY
Click here to add this to my saved trials
987
mi
from 43215
Bryan, TX
Click here to add this to my saved trials
73
mi
from 43215
Carlisle, OH
Click here to add this to my saved trials
907
mi
from 43215
Carrollton, TX
Click here to add this to my saved trials
1655
mi
from 43215
Chandler, AZ
Click here to add this to my saved trials
1943
mi
from 43215
Chino, CA
Click here to add this to my saved trials
166
mi
from 43215
Clairton, PA
Click here to add this to my saved trials
334
mi
from 43215
Clarksville, TN
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
384
mi
from 43215
Clinton, SC
Click here to add this to my saved trials
995
mi
from 43215
Coral Gables, FL
Click here to add this to my saved trials
1174
mi
from 43215
Corpus Christi, TX
Click here to add this to my saved trials
679
mi
from 43215
Council Bluffs, IA
Click here to add this to my saved trials
1967
mi
from 43215
Cypress, CA
Click here to add this to my saved trials
934
mi
from 43215
Delray Beach, FL
Click here to add this to my saved trials
163
mi
from 43215
Detroit, MI
Click here to add this to my saved trials
1514
mi
from 43215
Draper, UT
Click here to add this to my saved trials
355
mi
from 43215
Easley, SC
Click here to add this to my saved trials
767
mi
from 43215
Edgewater, FL
Click here to add this to my saved trials
339
mi
from 43215
Elkridge, MD
Click here to add this to my saved trials
393
mi
from 43215
Endwell, NY
Click here to add this to my saved trials
158
mi
from 43215
Fishers, IN
Click here to add this to my saved trials
164
mi
from 43215
Franklin, IN
Click here to add this to my saved trials
932
mi
from 43215
Ft. Myers, FL
Click here to add this to my saved trials
1963
mi
from 43215
Garden Grove, CA
Click here to add this to my saved trials
1653
mi
from 43215
Green Valley, AZ
Click here to add this to my saved trials
146
mi
from 43215
Greenfield, IN
Click here to add this to my saved trials
6
mi
from 43215
Grove City, OH
Click here to add this to my saved trials
403
mi
from 43215
Harleysville, PA
Click here to add this to my saved trials
345
mi
from 43215
Harrisburg, NC
Click here to add this to my saved trials
186
mi
from 43215
Hazard, KY
Click here to add this to my saved trials
1751
mi
from 43215
Henderson, NV
Click here to add this to my saved trials
989
mi
from 43215
Hialeah, FL
Click here to add this to my saved trials
322
mi
from 43215
High Point, NC
Click here to add this to my saved trials
4501
mi
from 43215
Honolulu, HI
Click here to add this to my saved trials
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
410
mi
from 43215
Huntsville, AL
Click here to add this to my saved trials
668
mi
from 43215
Jacksonville, FL
Click here to add this to my saved trials
614
mi
from 43215
Johnston, RI
Click here to add this to my saved trials
506
mi
from 43215
Jonesboro, AR
Click here to add this to my saved trials
1008
mi
from 43215
Katy, TX
Click here to add this to my saved trials
810
mi
from 43215
Kissimmee, FL
Click here to add this to my saved trials
1767
mi
from 43215
Las Vegas, NV
Click here to add this to my saved trials
Lauderdale Lakes, Florida 33313
968
mi
from 43215
Lauderdale Lakes, FL
Click here to add this to my saved trials
721
mi
from 43215
Lincoln, NE
Click here to add this to my saved trials
1975
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
832
mi
from 43215
Melbourne, FL
Click here to add this to my saved trials
1650
mi
from 43215
Mesa, AZ
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
983
mi
from 43215
Miami Gardens, FL
Click here to add this to my saved trials
700
mi
from 43215
Mobile, AL
Click here to add this to my saved trials
300
mi
from 43215
Morganton, NC
Click here to add this to my saved trials
127
mi
from 43215
Munci, IN
Click here to add this to my saved trials
494
mi
from 43215
Murrells Inlet, SC
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
779
mi
from 43215
Newton, KS
Click here to add this to my saved trials
621
mi
from 43215
North Little Rock, AR
Click here to add this to my saved trials
275
mi
from 43215
Oak Lawn, IL
Click here to add this to my saved trials
849
mi
from 43215
Oklahoma City, OK
Click here to add this to my saved trials
682
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
463
mi
from 43215
Orangeburg, SC
Click here to add this to my saved trials
1508
mi
from 43215
Orem, UT
Click here to add this to my saved trials
2017
mi
from 43215
Oxnard, CA
Click here to add this to my saved trials
1987
mi
from 43215
Pacific Palisades, CA
Click here to add this to my saved trials
1964
mi
from 43215
Pasadena, CA
Click here to add this to my saved trials
499
mi
from 43215
Pawleys Island, SC
Click here to add this to my saved trials
317
mi
from 43215
Philladelphia, PA
Click here to add this to my saved trials
1662
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
1965
mi
from 43215
Pico Rivera, CA
Click here to add this to my saved trials
837
mi
from 43215
Pinellas Park, FL
Click here to add this to my saved trials
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
1944
mi
from 43215
Pomona, CA
Click here to add this to my saved trials
757
mi
from 43215
Port Orange, FL
Click here to add this to my saved trials
2026
mi
from 43215
Portland, OR
Click here to add this to my saved trials
1071
mi
from 43215
Rapid City, SD
Click here to add this to my saved trials
341
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
2039
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
1513
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
181
mi
from 43215
Scottdale, PA
Click here to add this to my saved trials
401
mi
from 43215
Scottsboro, AL
Click here to add this to my saved trials
577
mi
from 43215
Searcy, AR
Click here to add this to my saved trials