Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316

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 (T705US316)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026349
• Other study ID #: T705US316
• Secondary ID: 2013-002149-13
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2013
• Last updated: October 20, 2015
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: MDVI, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Australia: Human Research Ethics CommitteeRussia: Pharmacological Committee, Ministry of HealthSouth Africa: Human Research Ethics CommitteeNew Zealand: Ministry of HealthUkraine: Ministry of HealthHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesTurkey: Ministry of HealthPoland: Ministry of HealthSpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products Agency
• 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: 860
• Est. completion date: March 2015
• Est. primary completion date: March 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
MDVI, LLC	MediVector, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Hungary,  Netherlands,  New Zealand,  Poland,  Russian Federation,  South Africa,  Spain,  Sweden,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in viral load	Changes in viral load (nasopharyngeal swabs) as measured by quantitative polymerase chain reaction (qPCR) and in the determination of median tissue culture infective dose (TCID50), from nasopharyngeal swabs at Visits 2, 3, 4, and 5; and log-transformed viral load (by qPCR and TCID50) area under the curves (AUCs).	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. Subjects will be considered to have symptoms alleviated if individual symptoms are no greater than mild and are confirmed to be no greater than mild at least 21.5 hours later. Similarly, resolution of fever is defined as temperature (oral) measurements to be < 38.0°C (<100.4°F) for subjects < 65 years old and < 37.8°C (100.0°F) for subjects = 65 years old, and measurements are confirmed at least 21.5 hours later. For the primary endpoint, the time periods of alleviation/fever resolution must be concurrent for symptoms and temperature.	21 days	No
Secondary	Time to alleviation 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. Subjects will be considered to have symptoms alleviated if individual symptoms are no greater than mild and are confirmed to be no greater than mild at least 21.5 hours later. Similarly, resolution of fever is defined as temperature (oral) measurements to be < 38.0°C (<100.4°F) for subjects < 65 years old and < 37.8°C (100.0°F) for subjects = 65 years old, and measurements are confirmed at least 21.5 hours later. Additional analyses of symptoms, including assessment of the impact of relevant covariates, will be specified in the Statistical Analysis Plan.	21 days	No
Secondary	To characterize the PK of favipiravir when used under clinical conditions	Population PK analysis of favipiravir with assessment of maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and total daily exposure AUC(0-24h) on Visits 1, 2, 3, 4 and 5	21 days	No

External Links

•   FAVOR Study Information site
•   Sponsor company website