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

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

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Favipiravir in Older Adult Patients With Uncomplicated Influenza

Conditions

• Influenza

Study Type

Interventional

Study Design

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• To evaluate the 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 ]

 

Arms	Assigned Interventions
1: Experimental: 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, 400 mg favipiravir BID x 4 days
2: Experimental: 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, 800 mg favipiravir BID x 4 days
Placebo: Placebo Comparator Placebo	Drug: Placebo comparator Placebo BID x 1 day, Placebo BID x 4 day

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 55-80 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).

Study Start

February 2010 – July 2010

Eligibility & Criteria

• Ages Eligible for Study: 55 Years to 80 Years
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.
• Patients ≥ 55 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.
• 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:

• 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.
• 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).
• 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.).
• 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.

Total Enrolment

384

Contact Details

Contact:
Ingrid Séïde, MSc
514-869-2021
iseide@incresearch.com

Australia, New South Wales 

• Blacktown
• Burwood
• Carlton
• Darlinghurst
• Glebe
• Maroubra
• Sydney 

Australia, Queensland

• Caboolture
• Maroochydore
• Sherwood