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

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00831103
• Other study ID #: EPB348-0201
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2009
• Last updated: December 3, 2013
• Start date: November 2007
• Est. completion date: June 2009

Study information

• Verified date: December 2013
• Source: Epiphany Biosciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female adults at least 18 years of age

• Patients with signs and symptoms consistent with acute herpes zoster disease, namely, a dermatomal vesicular rash which may be preceded by pain and parasthesias in the days before vesicular eruption

• Herpes Zoster associated rash present for = 72 hours

• Patients who are deemed to be immunocompetent based on history and physical exam

Exclusion Criteria:

• Females who are pregnant or nursing

• History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, psychiatric, renal, urological, endocrine, opthalmologic, or immune mediated disease including HIV or HBsAg positivity

• Chronic genital herpes

• Patients who received cytotoxic or immunosuppressive drug therapy within 3 months prior to study participation

• Previous vaccinations against Herpes Zoster

• Patients with > 50% of vesicles crusted at screen

• Patients who received topical or systemic antiviral medications or immunomodulatory agents for herpes zoster viral infections or capsaicin within 4 weeks of study participation

• Patients with a history of congenital, acquired, or corticosteroid induced immunodeficiency, including malignancy, significantly impaired renal function (creatinine clearance < 50 cc/min), and impaired hepatic function (ALT or AST levels > 3 times the upper limit of normal)

• QTc > 500msec

• Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, or famciclovir

• Patients with gastrointestinal dysfunction that might interfere with drug absorption

• Patients, considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Drug:
• EPB-348
Treated over seven days
• Valacyclovir
Treated over seven days

Locations

Country	Name	City	State
United States	Center for Clinical Studies-Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Epiphany Biosciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

Tyring SK, Plunkett S, Scribner AR, Broker RE, Herrod JN, Handke LT, Wise JM, Martin PA; Valomaciclovir Zoster Study Group. Valomaciclovir versus valacyclovir for the treatment of acute herpes zoster in immunocompetent adults: a randomized, double-blind, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm.		Daily assessment during the seven days of treament then weekly until Day 28	No