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

December 3, 2013 updated by: Epiphany Biosciences

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

373

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Center for Clinical Studies-Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EPB-348 1000 mg
EPB-348 1000 mg dosed once daily for seven days
Drug: EPB-348
Treated over seven days
Other Names:
  • Valomaciclovir Stearate
EXPERIMENTAL: EPB-348 2000 mg
EPB-348 2000 mg dosed once daily for seven days
Drug: EPB-348
Treated over seven days
Other Names:
  • Valomaciclovir Stearate
EXPERIMENTAL: EPB-348 3000 mg
EPB-348 3000 mg dosed once daily for seven days
Drug: EPB-348
Treated over seven days
Other Names:
  • Valomaciclovir Stearate
ACTIVE_COMPARATOR: Valacyclovir
Valacyclovir 1000 mg dosed three times daily for seven days
Drug: Valacyclovir
Treated over seven days
Other Names:
  • Valtrex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Daily assessment during the seven days of treament then weekly until Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epiphany Biosciences

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (ESTIMATE)

January 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPB348-0201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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