Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MDVI, LLC
ClinicalTrials.gov Identifier:
NCT01068912
First received: February 12, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated influenza.


Condition Intervention Phase
Influenza
Drug: Favipiravir
Drug: Placebo comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Favipiravir in Adult Patients With Uncomplicated Influenza

Resource links provided by NLM:


Further study details as provided by MDVI, LLC:

Primary Outcome Measures:
  • Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
    Overall time required from first study drug administration to alleviation of the 6 primary influenza symptoms and for temperature (oral) measurements to be less than 38.0°C for patients aged 20 to less than 65 years and less than 37.8°C for patients aged 65 years or older. "Alleviated" was defined as all 6 symptom scores had to be decreased to 1 or below and the decrease remain unchanged for 21.5 hours.


Enrollment: 530
Study Start Date: February 2010
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Experimental
Low-dose favipiravir regimen: 1000 mg favipiravir twice a day (BID) x 1 day, and 400 mg favipiravir BID x 4 days
Drug: Favipiravir
1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
Experimental: 2: Experimental
High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
Drug: Favipiravir
High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
Placebo Comparator: Placebo
Placebo
Drug: Placebo comparator
Placebo BID x 1 day, and Placebo BID x 4 days

Detailed Description:

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of a 5-day regimen of favipiravir in influenza patients aged 20-80 years. Enrolled patients will be randomly assigned to 1 of 3 parallel treatment dose groups:Placebo; Low-dose favipiravir (1000 mg favipiravir BID for 1 day, followed by 400 mg favipiravir BID for 4 days); High-dose favipiravir (1200 mg favipiravir BID for 1 day, followed by 800 mg favipiravir BID for 4 days).

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who test positive for influenza A or B by a commercially available Rapid Antigen Test (RAT) of the nasopharynx. A patient with a negative RAT result may still enroll if the sponsor and investigator agree that there is a known influenza outbreak circulating in the community.
  2. Patients ≥ 20 but < 65 years of age with a temperature (oral) of 100.4°F (38.0°C) or more; patients ≥ 65 years of age with a temperature (oral) of 100.0°F (37.8°C) or more at the first visit, or in the 6 hours prior if antipyretics were taken.
  3. Patients with 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment:

    • Cough
    • Sore throat
    • Headache
    • Nasal congestion
    • Feeling feverish
    • Body aches and pains
    • Fatigue (tiredness)

Exclusion Criteria:

  1. Patients who have had influenza symptoms or fever (i.e., one of the symptoms listed under the inclusion criteria) for 36 hours or more prior to study screening.
  2. Patients who have underlying chronic respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], chronic bronchitis, diffuse panbronchiolitis, bronchiectasis, pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or old tuberculosis).
  3. Patients who at the beginning of the study are suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung in a chest x-ray, etc.).
  4. Patients who have serious chronic diseases. For example, patients with HIV, cancer (i.e., requiring chemotherapy within the preceding 6 months), cirrhosis (end-stage), and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068912

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Locations
United States, Alabama
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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#412
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#404
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#422
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#411
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#410
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#407
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#413
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#418
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#415
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#409
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#419
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#420
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#423
Pretoria, South Africa
#417
Sandton, South Africa
#416
Somerset West, South Africa
#401
Soweto, South Africa
Sponsors and Collaborators
MDVI, LLC
Investigators
Study Director: Macy Guiont INC Research
  More Information

No publications provided

Responsible Party: MDVI, LLC
ClinicalTrials.gov Identifier: NCT01068912     History of Changes
Other Study ID Numbers: T705aUS204
Study First Received: February 12, 2010
Results First Received: February 11, 2014
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MDVI, LLC:
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014