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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2015
• Main ID: NCT02008344
• Date of registration: 08/12/2013
• Prospective Registration: No
• Primary sponsor: MDVI, LLC
• Public title: Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults
• Scientific title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza
• Date of first enrolment: December 2013
• Target sample size: 1161
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02008344
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, Canada, Colombia, Dominican Republic, El Salvador, Guatemala, Mexico, Peru, Puerto Rico, United States

Contacts

• Name: Carol Epstein, MD
• Affiliation: MediVector, Inc.

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Drug: favipiravir

Primary Outcome(s)

Time to alleviation of all primary influenza symptoms and fever [Time Frame: 21 days]

Secondary Outcome(s)

To characterize the PK of favipiravir when used under clinical conditions [Time Frame: 21 days]

Time to alleviation of each of the primary influenza symptoms and fever [Time Frame: 21 days]

Secondary ID(s)

U1111-1147-8470

T705US317

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MediVector, Inc.