Expired Study
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Houston, Texas 77030


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.

Study summary:

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.


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 is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Epiphany Biosciences

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification: S

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Stephen K Tyring, MD
Principal Investigator
University of Texas Health Science Center, Houston, Texas

Study Dates

Start Date:November 2007
Completion Date:June 2009
Completion Type:Actual
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:December 2013
Last Changed Date:December 3, 2013
First Received Date:January 26, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm.
Time Frame:Daily assessment during the seven days of treament then weekly until Day 28
Safety Issues:False

Study Interventions

Intervention Type:Drug
Description:Treated over seven days
Arm Name:EPB-348 1000 mg
Other Name:Valomaciclovir Stearate
Intervention Type:Drug
Description:Treated over seven days
Arm Name:Valacyclovir
Other Name:Valtrex

Study Arms

Study Arm Type:Active Comparator
Arm Name:Valacyclovir
Description:Valacyclovir 1000 mg dosed three times daily for seven days
Study Arm Type:Experimental
Arm Name:EPB-348 3000 mg
Description:EPB-348 3000 mg dosed once daily for seven days
Study Arm Type:Experimental
Arm Name:EPB-348 2000 mg
Description:EPB-348 2000 mg dosed once daily for seven days
Study Arm Type:Experimental
Arm Name:EPB-348 1000 mg
Description:EPB-348 1000 mg dosed once daily for seven days

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Epiphany Biosciences

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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, active-controlled trial. J Med Virol. 2012 Aug;84(8):1224-32. doi: 10.1002/jmv.23329.

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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