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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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)
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Secondary ID [1]
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0
2013-002149-13
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Secondary ID [2]
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T705US316
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to alleviation of all primary influenza symptoms and fever
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Assessment method [1]
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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.
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Timepoint [1]
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21 days
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Secondary outcome [1]
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Time to alleviation each of the primary influenza symptoms and fever
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Assessment method [1]
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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.
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Timepoint [1]
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21 days
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Secondary outcome [2]
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To characterize the PK of favipiravir when used under clinical conditions
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Assessment method [2]
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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
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Timepoint [2]
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21 days
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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
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2015
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Sample size
Target
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Accrual to date
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Final
860
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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- Bedford Park
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Recruitment postcode(s) [1]
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05042 - Bedford Park
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Ternopil's'ka Oblast
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Country [129]
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Ukraine
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State/province [129]
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Vinnyts'ka Oblast
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Country [130]
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Ukraine
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State/province [130]
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Kharkiv
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Country [131]
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Ukraine
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State/province [131]
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Kherson
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Country [132]
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Ukraine
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State/province [132]
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Kyiv
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Country [133]
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Ukraine
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State/province [133]
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Poltava
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Country [134]
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Ukraine
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State/province [134]
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Sumy
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
MDVI, LLC
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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MediVector, Inc.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.
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Trial website
https://clinicaltrials.gov/study/NCT02026349
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Trial related presentations / publications
Hayden FG, Lenk RP, Stonis L, Oldham-Creamer C, Kang LL, Epstein C. Favipiravir Treatment of Uncomplicated Influenza in Adults: Results of Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Trials. J Infect Dis. 2022 Nov 11;226(10):1790-1799. doi: 10.1093/infdis/jiac135.
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Public notes
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Contacts
Principal investigator
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Carol Epstein, MD
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Address
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MediVector, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Country
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02026349
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