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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008344
• Other study ID #: T705US317
• Secondary ID: U1111-1147-8470
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2013
• Last updated: October 20, 2015
• Start date: December 2013
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: MDVI, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaMexico: Ministry of HealthArgentina: Ministry of HealthBrazil: Ministry of HealthColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosDominican Republic: Consejo Nacional de Bioetica en SaludPeru: Ministry of HealthGuatemala: Ministry of Public Health and Social Assistance
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1161
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• favipiravir
Administered twice daily over 5 consecutive days for a total of 10 doses. Day 1: 1800 mg twice daily (loading doses) Days 2 through 5: 800 mg twice daily
• placebo
Administered twice daily over 5 consecutive days for a total of 10 doses. Day 1: 1800 mg twice daily (loading doses) Days 2 through 5: 800 mg twice daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
MDVI, LLC	MediVector, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in viral load	Changes in viral load as measured from nasopharyngeal swabs	15 days	No
Other	Safety	Adverse events and clinical laboratory tests for systemic safety including hematology, clinical chemistry, and urinalysis	21 days	Yes
Primary	Time to alleviation of all primary influenza symptoms and fever	Time from the start of study treatment until alleviation of all primary influenza symptoms (i.e. cough, sore throat, headache, nasal congestion, body aches and pains, fatigue) and to resolution of fever	21 days	No
Secondary	Time to alleviation of each of the primary influenza symptoms and fever	Time from the start of study treatment until alleviation of each of the following influenza symptoms (cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue) and to resolution of fever	21 days	No
Secondary	To characterize the PK of favipiravir when used under clinical conditions		21 days	No

External Links

•   FAVOR Study Information site
•   Sponsor company website