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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02026349
Recruitment Status : Completed
First Posted : January 3, 2014
Last Update Posted : November 11, 2015
Sponsor:
Collaborator:
MediVector, Inc.
Information provided by (Responsible Party):
MDVI, LLC

Tracking Information
First Submitted Date  ICMJE December 19, 2013
First Posted Date  ICMJE January 3, 2014
Last Update Posted Date November 11, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2013)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 30, 2013)
  • 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).
  • Safety [ Time Frame: 21 days ]
    Adverse events and clinical laboratory tests for systemic safety including hematology, clinical chemistry, and urinalysis
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza (T705US316)
Brief Summary The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Influenza
Intervention  ICMJE
  • 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 Name: T-705
  • Drug: Placebo
    Administered twice daily over 5 consecutive days for a total of 10 doses.
Study Arms  ICMJE
  • Active Comparator: favipiravir
    Intervention: Drug: favipiravir
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2015)
860
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2013)
660
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Bulgaria,   Hungary,   Netherlands,   New Zealand,   Poland,   Russian Federation,   South Africa,   Spain,   Sweden,   Turkey,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02026349
Other Study ID Numbers  ICMJE T705US316
2013-002149-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MDVI, LLC
Study Sponsor  ICMJE MDVI, LLC
Collaborators  ICMJE MediVector, Inc.
Investigators  ICMJE
Study Director: Carol Epstein, MD MediVector, Inc.
PRS Account MDVI, LLC
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP