Overview

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

Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MDVI, LLC
Collaborator:
MediVector, Inc.
Treatments:
Favipiravir
Criteria
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)