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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Epiphany Biosciences
ClinicalTrials.gov Identifier:
NCT00831103
First received: January 26, 2009
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Herpes Zoster
Drug: EPB-348
Drug: Valacyclovir
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Epiphany Biosciences:

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. [ Time Frame: Daily assessment during the seven days of treament then weekly until Day 28 ] [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: November 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EPB-348 1000 mg
EPB-348 1000 mg dosed once daily for seven days
Drug: EPB-348
Treated over seven days
Other Name: 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 Name: 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 Name: Valomaciclovir Stearate
Active Comparator: Valacyclovir
Valacyclovir 1000 mg dosed three times daily for seven days
Drug: Valacyclovir
Treated over seven days
Other Name: Valtrex

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831103

Locations
United States, Texas
Center for Clinical Studies-Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Epiphany Biosciences
Investigators
Principal Investigator: Stephen K Tyring, MD University of Texas Health Science Center, Houston, Texas
  More Information

Publications:
Responsible Party: Epiphany Biosciences
ClinicalTrials.gov Identifier: NCT00831103     History of Changes
Other Study ID Numbers: EPB348-0201
Study First Received: January 26, 2009
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Epiphany Biosciences:
EPB348
Valomaciclovir Stearate
Valacyclovir
Herpes Zoster
Shingles

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014