NCT01068912

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 530 (actual)
• Sponsor: MDVI, LLC · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

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).

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Favipiravir	1000 mg favipiravir BID x 1 day, and 400 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
DRUG	Placebo comparator	Placebo BID x 1 day, and Placebo BID x 4 days

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2010-02-15
• Last updated: 2015-11-18
• Results posted: 2014-03-27

Locations

228 sites across 7 countries: United States, Australia, Chile, New Zealand, Paraguay, Peru, South Africa