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

NCT01068912 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2015-11-18

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • MDVI, LLC

    lead INDUSTRY

Principal Investigators

  • Macy Guiont · Syneos Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-04-30
Completion
2012-05-31

Countries

  • United States
  • Australia
  • Chile
  • New Zealand
  • Paraguay
  • Peru
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068912 on ClinicalTrials.gov