NCT01096576

A Study of Balapiravir in Patients With Dengue Virus Infection

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Dengue Virus Polymerase Inhibitor (Balapiravir) in Male Patients With Confirmed Dengue Virus Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue virus infection whose symptoms began within the 48 hours preceding the first administration of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an out-patient follow-up to week 12. Target sample size is \<200

Conditions

• Dengue

Interventions

Type	Name	Description
DRUG	balapiravir [RO4588161]	sequential cohorts receiving doses orally twice daily for 5 days
DRUG	placebo	orally twice daily for 5 days

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-03-31
• Last updated: 2016-11-02

Locations

1 site across 1 country: Vietnam