NCT00831103

A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster

A Randomized, Double-blind, Active-controlled, Multi-center, Parallel-group Dose-ranging Study Assessing the Safety and Efficacy of EPB-348 Versus Valacyclovir Among Immunocompetent Patients With an Acute Episode of Herpes Zoster

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 373 (actual)
• Sponsor: Epiphany Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the pharmacokinetics and dosage of EPB-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster.

Detailed description

In cells infected with varicella-zoster virus, there is evidence to suggest that EPB-348 could offer clinically important advantages in the treatment of acute herpes zoster over currently available therapies due to rapid absorption and conversion to the active moiety as well as a longer intra-cellular half-life in infected cells. Clinically, these characteristics could translate into once-daily dosing versus thrice-daily dosing as seen with current therapy, leading to a higher rate of compliance and quality-of-life, especially among elderly patients. The objective of EPB348-0201 is to determine the pharmacokinetics and dosage of EPB-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster. This multi-center study will randomly assign patients to either EPB-348 1000 mg once daily or EPB-348 2000 mg once daily or valacyclovir 1000 mg three times daily.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
DRUG	EPB-348	Treated over seven days
DRUG	Valacyclovir	Treated over seven days

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2009-01-28
• Last updated: 2013-12-05

Locations

1 site across 1 country: United States