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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
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)
Secondary ID [1] 0 0
2013-002149-13
Secondary ID [2] 0 0
T705US316
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to alleviation of all primary influenza symptoms and fever
Timepoint [1] 0 0
21 days
Secondary outcome [1] 0 0
Time to alleviation each of the primary influenza symptoms and fever
Timepoint [1] 0 0
21 days
Secondary outcome [2] 0 0
To characterize the PK of favipiravir when used under clinical conditions
Timepoint [2] 0 0
21 days

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
860
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
- Bedford Park
Recruitment postcode(s) [1] 0 0
05042 - Bedford Park
Recruitment outside Australia
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Ukraine
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Poltava
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Ukraine
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Sumy

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MDVI, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
MediVector, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.
Trial website
https://clinicaltrials.gov/study/NCT02026349
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.
Public notes

Contacts
Principal investigator
Name 0 0
Carol Epstein, MD
Address 0 0
MediVector, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02026349