Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02026349
Registration number
NCT02026349
Ethics application status
Date submitted
19/12/2013
Date registered
3/01/2014
Date last updated
11/11/2015
Titles & IDs
Public title
Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316
Query!
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 (T705US316)
Query!
Secondary ID [1]
0
0
2013-002149-13
Query!
Secondary ID [2]
0
0
T705US316
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Influenza
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - favipiravir
Treatment: Drugs - Placebo
Active Comparator: favipiravir -
Placebo Comparator: placebo -
Treatment: Drugs: 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
Treatment: Drugs: Placebo
Administered twice daily over 5 consecutive days for a total of 10 doses.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time to alleviation of all primary influenza symptoms and fever
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
21 days
Query!
Secondary outcome [1]
0
0
Time to alleviation each of the primary influenza symptoms and fever
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
21 days
Query!
Secondary outcome [2]
0
0
To characterize the PK of favipiravir when used under clinical conditions
Query!
Assessment method [2]
0
0
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
Query!
Timepoint [2]
0
0
21 days
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/03/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
860
Query!
Recruitment in Australia
Recruitment state(s)
SA
Query!
Recruitment hospital [1]
0
0
- Bedford Park
Query!
Recruitment postcode(s) [1]
0
0
05042 - Bedford Park
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Nebraska
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Nevada
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
North Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Pennsylvania
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
South Carolina
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Texas
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Utah
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Virginia
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Wisconsin
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Antwerpen
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Brussels
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Hainaut
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Limburg
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Liège
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Deurne
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Gribomont
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Linkebeek
Query!
Country [28]
0
0
Bulgaria
Query!
State/province [28]
0
0
Sofia-Grad
Query!
Country [29]
0
0
Bulgaria
Query!
State/province [29]
0
0
Burgas
Query!
Country [30]
0
0
Bulgaria
Query!
State/province [30]
0
0
Gabrovo
Query!
Country [31]
0
0
Bulgaria
Query!
State/province [31]
0
0
Haskovo
Query!
Country [32]
0
0
Bulgaria
Query!
State/province [32]
0
0
Plovdiv
Query!
Country [33]
0
0
Bulgaria
Query!
State/province [33]
0
0
Ruse
Query!
Country [34]
0
0
Bulgaria
Query!
State/province [34]
0
0
Samokov
Query!
Country [35]
0
0
Bulgaria
Query!
State/province [35]
0
0
Sevlievo
Query!
Country [36]
0
0
Bulgaria
Query!
State/province [36]
0
0
Sliven
Query!
Country [37]
0
0
Bulgaria
Query!
State/province [37]
0
0
Smolyan
Query!
Country [38]
0
0
Bulgaria
Query!
State/province [38]
0
0
Sofia
Query!
Country [39]
0
0
Bulgaria
Query!
State/province [39]
0
0
Varna
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Veliko Tarnovo
Query!
Country [41]
0
0
Hungary
Query!
State/province [41]
0
0
Balassagyarmat
Query!
Country [42]
0
0
Hungary
Query!
State/province [42]
0
0
Budapest
Query!
Country [43]
0
0
Hungary
Query!
State/province [43]
0
0
Csongrad
Query!
Country [44]
0
0
Hungary
Query!
State/province [44]
0
0
Debrecen
Query!
Country [45]
0
0
Hungary
Query!
State/province [45]
0
0
Gyula
Query!
Country [46]
0
0
Hungary
Query!
State/province [46]
0
0
Gödöllo
Query!
Country [47]
0
0
Hungary
Query!
State/province [47]
0
0
Nyiregyhaza
Query!
Country [48]
0
0
Hungary
Query!
State/province [48]
0
0
Zalaegerszeg
Query!
Country [49]
0
0
Netherlands
Query!
State/province [49]
0
0
Overijssel
Query!
Country [50]
0
0
Netherlands
Query!
State/province [50]
0
0
Overissel
Query!
Country [51]
0
0
Netherlands
Query!
State/province [51]
0
0
Zuid-Holland
Query!
Country [52]
0
0
Netherlands
Query!
State/province [52]
0
0
Den Haag
Query!
Country [53]
0
0
Netherlands
Query!
State/province [53]
0
0
Lieshout
Query!
Country [54]
0
0
Netherlands
Query!
State/province [54]
0
0
Nijverdal
Query!
Country [55]
0
0
Netherlands
Query!
State/province [55]
0
0
Rotterdam
Query!
Country [56]
0
0
Netherlands
Query!
State/province [56]
0
0
Zwijndrecht
Query!
Country [57]
0
0
New Zealand
Query!
State/province [57]
0
0
North Island
Query!
Country [58]
0
0
New Zealand
Query!
State/province [58]
0
0
South Island
Query!
Country [59]
0
0
New Zealand
Query!
State/province [59]
0
0
Waikato
Query!
Country [60]
0
0
New Zealand
Query!
State/province [60]
0
0
Tauranga
Query!
Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Dolnoslaskie
Query!
Country [62]
0
0
Poland
Query!
State/province [62]
0
0
Kujawsko-pomorskie
Query!
Country [63]
0
0
Poland
Query!
State/province [63]
0
0
Lubelskie
Query!
Country [64]
0
0
Poland
Query!
State/province [64]
0
0
Lódzkie
Query!
Country [65]
0
0
Poland
Query!
State/province [65]
0
0
Malopolskie
Query!
Country [66]
0
0
Poland
Query!
State/province [66]
0
0
Mazowieckie
Query!
Country [67]
0
0
Poland
Query!
State/province [67]
0
0
Podkarpackie
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Slaskie
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Katowice
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Krakow
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Kraków
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Lódz
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Ostroda
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Oswiecim
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
Arkangelsk
Query!
Country [76]
0
0
Russian Federation
Query!
State/province [76]
0
0
Kazan
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
Moscow
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
Novosibirsk
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Ryazan
Query!
Country [80]
0
0
Russian Federation
Query!
State/province [80]
0
0
Saratov
Query!
Country [81]
0
0
Russian Federation
Query!
State/province [81]
0
0
St. Petersburg
Query!
Country [82]
0
0
Russian Federation
Query!
State/province [82]
0
0
Tomsk
Query!
Country [83]
0
0
Russian Federation
Query!
State/province [83]
0
0
Vladimir
Query!
Country [84]
0
0
Russian Federation
Query!
State/province [84]
0
0
Yaroslavl
Query!
Country [85]
0
0
South Africa
Query!
State/province [85]
0
0
Free State
Query!
Country [86]
0
0
South Africa
Query!
State/province [86]
0
0
Gauteng
Query!
Country [87]
0
0
South Africa
Query!
State/province [87]
0
0
Kwazulu - Natal
Query!
Country [88]
0
0
South Africa
Query!
State/province [88]
0
0
Mpumalanga
Query!
Country [89]
0
0
South Africa
Query!
State/province [89]
0
0
Western Cape
Query!
Country [90]
0
0
South Africa
Query!
State/province [90]
0
0
Cape Town
Query!
Country [91]
0
0
South Africa
Query!
State/province [91]
0
0
Durban
Query!
Country [92]
0
0
South Africa
Query!
State/province [92]
0
0
Johannesburg
Query!
Country [93]
0
0
South Africa
Query!
State/province [93]
0
0
Krugersdorp
Query!
Country [94]
0
0
South Africa
Query!
State/province [94]
0
0
Potchefstroom
Query!
Country [95]
0
0
South Africa
Query!
State/province [95]
0
0
Pretoria
Query!
Country [96]
0
0
South Africa
Query!
State/province [96]
0
0
Sophiatown, Johannesburg
Query!
Country [97]
0
0
South Africa
Query!
State/province [97]
0
0
Umkomaas
Query!
Country [98]
0
0
South Africa
Query!
State/province [98]
0
0
Welkom
Query!
Country [99]
0
0
Spain
Query!
State/province [99]
0
0
Alicante
Query!
Country [100]
0
0
Spain
Query!
State/province [100]
0
0
Barcelona
Query!
Country [101]
0
0
Spain
Query!
State/province [101]
0
0
Castellón
Query!
Country [102]
0
0
Spain
Query!
State/province [102]
0
0
Cataluña
Query!
Country [103]
0
0
Spain
Query!
State/province [103]
0
0
Girona
Query!
Country [104]
0
0
Spain
Query!
State/province [104]
0
0
Tarragona
Query!
Country [105]
0
0
Sweden
Query!
State/province [105]
0
0
Skane lan
Query!
Country [106]
0
0
Sweden
Query!
State/province [106]
0
0
Sodermanlands lan
Query!
Country [107]
0
0
Sweden
Query!
State/province [107]
0
0
Uppsala Ian
Query!
Country [108]
0
0
Sweden
Query!
State/province [108]
0
0
Vastra Gotalands lan
Query!
Country [109]
0
0
Sweden
Query!
State/province [109]
0
0
Karlskrona
Query!
Country [110]
0
0
Sweden
Query!
State/province [110]
0
0
Linköping
Query!
Country [111]
0
0
Sweden
Query!
State/province [111]
0
0
Malmö
Query!
Country [112]
0
0
Sweden
Query!
State/province [112]
0
0
Uppsala
Query!
Country [113]
0
0
Turkey
Query!
State/province [113]
0
0
Ankara
Query!
Country [114]
0
0
Turkey
Query!
State/province [114]
0
0
Diyarbakir
Query!
Country [115]
0
0
Turkey
Query!
State/province [115]
0
0
Duzce
Query!
Country [116]
0
0
Turkey
Query!
State/province [116]
0
0
Erzurum
Query!
Country [117]
0
0
Turkey
Query!
State/province [117]
0
0
Eskisehir
Query!
Country [118]
0
0
Turkey
Query!
State/province [118]
0
0
Izmir
Query!
Country [119]
0
0
Turkey
Query!
State/province [119]
0
0
Konya
Query!
Country [120]
0
0
Turkey
Query!
State/province [120]
0
0
Samsun
Query!
Country [121]
0
0
Turkey
Query!
State/province [121]
0
0
Trabzon
Query!
Country [122]
0
0
Ukraine
Query!
State/province [122]
0
0
Chernivets'ka Oblast
Query!
Country [123]
0
0
Ukraine
Query!
State/province [123]
0
0
Ivano-Frankivs'ka Oblast
Query!
Country [124]
0
0
Ukraine
Query!
State/province [124]
0
0
Kharkivs'ka Oblast
Query!
Country [125]
0
0
Ukraine
Query!
State/province [125]
0
0
Kyïvs'ka Oblast
Query!
Country [126]
0
0
Ukraine
Query!
State/province [126]
0
0
Kyïv
Query!
Country [127]
0
0
Ukraine
Query!
State/province [127]
0
0
Odes'ka Oblast
Query!
Country [128]
0
0
Ukraine
Query!
State/province [128]
0
0
Ternopil's'ka Oblast
Query!
Country [129]
0
0
Ukraine
Query!
State/province [129]
0
0
Vinnyts'ka Oblast
Query!
Country [130]
0
0
Ukraine
Query!
State/province [130]
0
0
Kharkiv
Query!
Country [131]
0
0
Ukraine
Query!
State/province [131]
0
0
Kherson
Query!
Country [132]
0
0
Ukraine
Query!
State/province [132]
0
0
Kyiv
Query!
Country [133]
0
0
Ukraine
Query!
State/province [133]
0
0
Poltava
Query!
Country [134]
0
0
Ukraine
Query!
State/province [134]
0
0
Sumy
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
MDVI, LLC
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
MediVector, Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to determine if favipiravir is effective in reducing the time to
resolution of influenza symptoms.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02026349
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Carol Epstein, MD
Query!
Address
0
0
MediVector, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02026349
Download to PDF