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

October 20, 2015 updated by: MDVI, LLC

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza (T705US316)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

860

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Bedford Park, South Australia, Australia, 05042
  • Belgium
      • Deurne, Belgium, 2100
      • Gribomont, Belgium, 6887
      • Linkebeek, Belgium, 1630
    • Antwerpen
      • Deurne, Antwerpen, Belgium, 2100
    • Brussels
      • Bruxelles, Brussels, Belgium, 1080
    • Hainaut
      • Gozee, Hainaut, Belgium, 6534
      • Mont-sur-Marchienne, Hainaut, Belgium, 6032
    • Limburg
      • Halen, Limburg, Belgium, 3545
      • Ham, Limburg, Belgium, 3945
    • Liège
      • Chenée, Liège, Belgium, 4032
  • Bulgaria
      • Burgas, Bulgaria, 8000
      • Burgas, Bulgaria, 8112
      • Gabrovo, Bulgaria, 5300
      • Haskovo, Bulgaria, 6300
      • Plovdiv, Bulgaria, 4002
      • Plovdiv, Bulgaria, 4000
      • Ruse, Bulgaria, 7002
      • Ruse, Bulgaria, 7001
      • Samokov, Bulgaria, 2000
      • Sevlievo, Bulgaria, 5400
      • Sliven, Bulgaria, 8800
      • Smolyan, Bulgaria, 4700
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1000
      • Sofia, Bulgaria, 1303
      • Sofia, Bulgaria, 1463
      • Sofia, Bulgaria, 1505
      • Sofia, Bulgaria, 1618
      • Varna, Bulgaria, 9000
      • Varna, Bulgaria, 9020
      • Veliko Tarnovo, Bulgaria, 5000
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1000
  • Hungary
      • Balassagyarmat, Hungary, 2660
      • Budapest, Hungary, 1135
      • Csongrad, Hungary, 6640
      • Debrecen, Hungary, 4043
      • Gyula, Hungary, 5700
      • Gödöllő, Hungary, 2100
      • Nyiregyhaza, Hungary
      • Zalaegerszeg, Hungary, 8900
  • Netherlands
      • Den Haag, Netherlands, 2526 HW
      • Lieshout, Netherlands, 5737 CB
      • Nijverdal, Netherlands, 7442 LS
      • Rotterdam, Netherlands, 3039 BD
      • Zwijndrecht, Netherlands, 3334 CL
    • Overijssel
      • Nijverdal, Overijssel, Netherlands, 7442 LS
    • Overissel
      • Nijverdal, Overissel, Netherlands, 7442 LS
    • Zuid-Holland
      • Hoogvliet, Zuid-Holland, Netherlands, 3192 JN
  • New Zealand
      • Tauranga, New Zealand, 3143
    • North Island
      • Auckland, North Island, New Zealand, 0612
    • South Island
      • Christchurch, South Island, New Zealand
    • Waikato
      • Hamilton, Waikato, New Zealand, 3204
  • Poland
      • Katowice, Poland, 40-752
      • Katowice, Poland, 40-211
      • Krakow, Poland, 31-011
      • Kraków, Poland, 31-637
      • Lódz, Poland, 93-328
      • Ostroda, Poland, 14-100
      • Oswiecim, Poland, 32-600
    • Dolnoslaskie
      • Olesnica, Dolnoslaskie, Poland, 56-400
      • Wroclaw, Dolnoslaskie, Poland, 53-301
      • Wroclaw, Dolnoslaskie, Poland, 54-144
    • Kujawsko-pomorskie
      • Torun, Kujawsko-pomorskie, Poland, 87-100
    • Lubelskie
      • Swidnik, Lubelskie, Poland, 21-040
    • Lódzkie
      • Lodz, Lódzkie, Poland, 91-463
      • Zgierz, Lódzkie, Poland, 95-100
    • Malopolskie
      • Tarnów, Malopolskie, Poland, 33-100
    • Mazowieckie
      • Losice, Mazowieckie, Poland, 08-200
    • Podkarpackie
      • Debica, Podkarpackie, Poland, 39-200
      • Rzeszow, Podkarpackie, Poland, 35-055
    • Slaskie
      • Katowice, Slaskie, Poland, 40-211
      • Katowice, Slaskie, Poland, 40-772
  • Russian Federation
      • Arkangelsk, Russian Federation, 163000
      • Kazan, Russian Federation, 420012
      • Moscow, Russian Federation, 129090
      • Novosibirsk, Russian Federation, 630051
      • Novosibirsk, Russian Federation, 630099
      • Ryazan, Russian Federation, 390005
      • Saratov, Russian Federation, 410028
      • St. Petersburg, Russian Federation
      • St. Petersburg, Russian Federation, 196247
      • St. Petersburg, Russian Federation, 194044
      • St. Petersburg, Russian Federation, 198328
      • Tomsk, Russian Federation, 634050
      • Vladimir, Russian Federation, 600023
      • Yaroslavl, Russian Federation, 150007
  • South Africa
      • Cape Town, South Africa, 7572
      • Durban, South Africa, 4068
      • Johannesburg, South Africa, 2113
      • Krugersdorp, South Africa, 1724
      • Potchefstroom, South Africa, 2531
      • Pretoria, South Africa, 0001
      • Sophiatown, Johannesburg, South Africa, 2129
      • Umkomaas, South Africa, 4170
      • Welkom, South Africa, 9459
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
    • Gauteng
      • Bryanston, Gauteng, South Africa, 2021
      • Johannesburg, Gauteng, South Africa, 1619
      • Johannesburg, Gauteng, South Africa, 1818
      • Johannesburg, Gauteng, South Africa, 2113
      • Pretoria, Gauteng, South Africa, 0084
      • Pretoria, Gauteng, South Africa, 0081
      • Pretoria, Gauteng, South Africa, 0140
      • Pretoria, Gauteng, South Africa, 1501
      • Sophiatown, Johannesburg, Gauteng, South Africa, 2129
      • Soweto, Gauteng, South Africa, 1818
    • Kwazulu - Natal
      • Amanzimtoti, Kwazulu - Natal, South Africa, 4126
      • Dundee, Kwazulu - Natal, South Africa, 3000
    • Mpumalanga
      • Middelburg, Mpumalanga, South Africa, 1050
      • Witbank, Mpumalanga, South Africa, 1035
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
      • Cape Town, Western Cape, South Africa, 7965
      • Cape Town, Western Cape, South Africa, 8002
      • Paarl, Western Cape, South Africa, 7646
      • Worcester, Western Cape, South Africa, 6850
  • Spain
      • Alicante, Spain, 03610
      • Barcelona, Spain, 08907
      • Barcelona, Spain, 08041
      • Barcelona, Spain, 08028
      • Tarragona, Spain, 43007
    • Alicante
      • Benidorm, Alicante, Spain, 03500
      • Orihuela, Alicante, Spain, 03300
    • Barcelona
      • Badalona, Barcelona, Spain, 08917
    • Castellón
      • Castellon de la Plana, Castellón, Spain, 12005
    • Cataluña
      • Barcelona, Cataluña, Spain, 08036
    • Girona
      • Llanca, Girona, Spain, 17490
  • Sweden
      • Karlskrona, Sweden, SE-37141
      • Linköping, Sweden, SE-58216
      • Malmö, Sweden, SE-20502
      • Uppsala, Sweden, SE-75185
    • Skane lan
      • Malmö, Skane lan, Sweden, SE-21152
    • Sodermanlands lan
      • Stockholm, Sodermanlands lan, Sweden, SE-11157
      • Stockholm, Sodermanlands lan, Sweden, SE-11522
    • Uppsala Ian
      • Uppsala, Uppsala Ian, Sweden, SE-75185
    • Vastra Gotalands lan
      • Göteborg, Vastra Gotalands lan, Sweden, SE-41345
  • Turkey
      • Ankara, Turkey, 06100
      • Diyarbakir, Turkey, 21280
      • Duzce, Turkey, 81600
      • Erzurum, Turkey, 25240
      • Eskisehir, Turkey, 26480
      • Izmir, Turkey, 35100
      • Izmir, Turkey, 35210
      • Konya, Turkey, 42075
      • Samsun, Turkey, 55139
      • Trabzon, Turkey, 61080
  • Ukraine
      • Kharkiv, Ukraine, 61052
      • Kherson, Ukraine, 73013
      • Kyiv, Ukraine, 01601
      • Kyiv, Ukraine, 02232
      • Kyiv, Ukraine, 04050
      • Poltava, Ukraine, 36000
      • Sumy, Ukraine, 40015
    • Chernivets'ka Oblast
      • Chernivtsi, Chernivets'ka Oblast, Ukraine, 58005
    • Ivano-Frankivs'ka Oblast
      • Ivano-Frankivsk, Ivano-Frankivs'ka Oblast, Ukraine, 76018
    • Kharkivs'ka Oblast
      • Kharkiv, Kharkivs'ka Oblast, Ukraine, 61007
    • Kyïv
      • Kyiv, Kyïv, Ukraine, 04050
    • Kyïvs'ka Oblast
      • Kyiv, Kyïvs'ka Oblast, Ukraine, 02002
    • Odes'ka Oblast
      • Odesa, Odes'ka Oblast, Ukraine, 65023
      • Odesa, Odes'ka Oblast, Ukraine, 65114
    • Ternopil's'ka Oblast
      • Ternopil, Ternopil's'ka Oblast, Ukraine, 46008
    • Vinnyts'ka Oblast
      • Vinnytsya, Vinnyts'ka Oblast, Ukraine, 21029
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
      • Birmingham, Alabama, United States, 06117
      • Hunstville, Alabama, United States, 35801
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • California
      • Los Angeles, California, United States, 90017
      • Los Angeles, California, United States, 90020
      • Orange, California, United States, 92866
      • Sacramento, California, United States, 95825
      • San Diego, California, United States, 92120
      • San Diego, California, United States, 92128
      • Tustin, California, United States, 92780
      • Upland, California, United States, 91786
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
    • Connecticut
      • Hamden, Connecticut, United States, 65140
    • Florida
      • Bradenton, Florida, United States, 34205
      • Brooksville, Florida, United States, 34601
      • Gainesville, Florida, United States, 32607
      • Gainesville, Florida, United States, 32605
      • Hialeah, Florida, United States, 33016
      • Hialeah, Florida, United States, 33012
      • Lakeland Hills, Florida, United States, 33805
      • Miami, Florida, United States, 33173
      • Miami, Florida, United States, 33137
      • Miami, Florida, United States, 33126
      • Miami, Florida, United States, 33135
      • Saint Cloud, Florida, United States, 34769
      • Saint Petersburg, Florida, United States, 33709
      • South Miami, Florida, United States, 33143
      • Tampa, Florida, United States, 33606
    • Georgia
      • Atlanta, Georgia, United States, 30312
      • Snellville, Georgia, United States, 30039
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
    • Louisiana
      • Monroe, Louisiana, United States, 71201
      • Opelousas, Louisiana, United States, 70570
    • Michigan
      • Flint, Michigan, United States, 48504
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • Nevada
      • Las Vegas, Nevada, United States, 89121
    • North Carolina
      • Hickory, North Carolina, United States, 28601
      • Morganton, North Carolina, United States, 28655
      • Winston Salem, North Carolina, United States, 27103
    • Pennsylvania
      • Lansdale, Pennsylvania, United States, 19446
      • Pittsburgh, Pennsylvania, United States, 15236
      • Smithfield, Pennsylvania, United States, 15478
      • Uniontown, Pennsylvania, United States, 15401
    • South Carolina
      • Gaffney, South Carolina, United States, 29341
      • Greenville, South Carolina, United States, 29615
      • Greer, South Carolina, United States, 29651
      • Simpsonville, South Carolina, United States, 29681
    • Texas
      • Arlington, Texas, United States, 76012
      • Austin, Texas, United States, 78756
      • Carrollton, Texas, United States, 75010
      • Forth Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77062
      • Plano, Texas, United States, 75093
      • San Antonio, Texas, United States, 78207
    • Utah
      • Salt Lake City, Utah, United States, 84121
      • Salt Lake City, Utah, United States, 84109
      • South Jordan, Utah, United States, 84095
    • Virginia
      • Arlington, Virginia, United States, 22203
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Placebo
Administered twice daily over 5 consecutive days for a total of 10 doses.
Active Comparator: favipiravir
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
Other Names:
  • T-705

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to alleviation of all primary influenza symptoms and fever
Time Frame: 21 days
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to alleviation each of the primary influenza symptoms and fever
Time Frame: 21 days
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
To characterize the PK of favipiravir when used under clinical conditions
Time Frame: 21 days
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in viral load
Time Frame: 15 days
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
Safety
Time Frame: 21 days
Adverse events and clinical laboratory tests for systemic safety including hematology, clinical chemistry, and urinalysis
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MDVI, LLC

Collaborators

MediVector, Inc.

Investigators

  • Study Director: Carol Epstein, MD, MediVector, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Estimate)

November 11, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T705US316
  • 2013-002149-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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