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

Primary Purpose

Herpes Zoster

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

EPB-348

Valacyclovir

About this trial

This is an interventional treatment trial for Herpes Zoster focused on measuring EPB348, Valomaciclovir Stearate, Valacyclovir, Herpes Zoster, Shingles

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for Clinical Studies-Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

EPB-348 1000 mg

EPB-348 2000 mg

EPB-348 3000 mg

Valacyclovir

Arm Description

EPB-348 1000 mg dosed once daily for seven days

EPB-348 2000 mg dosed once daily for seven days

EPB-348 3000 mg dosed once daily for seven days

Valacyclovir 1000 mg dosed three times daily for seven days

Outcomes

Primary Outcome Measures

To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm.

Secondary Outcome Measures

Full Information

NCT ID

NCT00831103

First Posted

January 26, 2009

Last Updated

December 3, 2013

Sponsor

Epiphany Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT00831103

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Epiphany Biosciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Zoster

Keywords

EPB348, Valomaciclovir Stearate, Valacyclovir, Herpes Zoster, Shingles

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

373 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EPB-348 1000 mg

Arm Type

Experimental

Arm Description

EPB-348 1000 mg dosed once daily for seven days

Arm Title

EPB-348 2000 mg

Arm Type

Experimental

Arm Description

EPB-348 2000 mg dosed once daily for seven days

Arm Title

EPB-348 3000 mg

Arm Type

Experimental

Arm Description

EPB-348 3000 mg dosed once daily for seven days

Arm Title

Valacyclovir

Arm Type

Active Comparator

Arm Description

Valacyclovir 1000 mg dosed three times daily for seven days

Intervention Type

Drug

Intervention Name(s)

EPB-348

Other Intervention Name(s)

Valomaciclovir Stearate

Intervention Description

Treated over seven days

Intervention Type

Drug

Intervention Name(s)

Valacyclovir

Other Intervention Name(s)

Valtrex

Intervention Description

Treated over seven days

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen K Tyring, MD

Organizational Affiliation

University of Texas Health Science Center, Houston, Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Clinical Studies-Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22711350

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.

Results Reference

result

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

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