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

January 26, 2009
December 3, 2013
November 2007
June 2009   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00831103 on ClinicalTrials.gov Archive Site
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A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Herpes Zoster
  • Drug: EPB-348
    Treated over seven days
    Other Name: Valomaciclovir Stearate
  • Drug: Valacyclovir
    Treated over seven days
    Other Name: Valtrex
  • Experimental: EPB-348 1000 mg
    EPB-348 1000 mg dosed once daily for seven days
    Intervention: Drug: EPB-348
  • Experimental: EPB-348 2000 mg
    EPB-348 2000 mg dosed once daily for seven days
    Intervention: Drug: EPB-348
  • Experimental: EPB-348 3000 mg
    EPB-348 3000 mg dosed once daily for seven days
    Intervention: Drug: EPB-348
  • Active Comparator: Valacyclovir
    Valacyclovir 1000 mg dosed three times daily for seven days
    Intervention: Drug: Valacyclovir
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
373
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00831103
EPB348-0201
No
Epiphany Biosciences
Epiphany Biosciences
Not Provided
Principal Investigator: Stephen K Tyring, MD University of Texas Health Science Center, Houston, Texas
Epiphany Biosciences
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP