Title

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
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    373
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.
Study Started
Nov 30
2007
Primary Completion
Jun 30
2009
Study Completion
Jun 30
2009
Last Update
Dec 05
2013
Estimate

Drug EPB-348

Treated over seven days

  • Other names: Valomaciclovir Stearate

Drug Valacyclovir

Treated over seven days

  • Other names: Valtrex

EPB-348 1000 mg Experimental

EPB-348 1000 mg dosed once daily for seven days

EPB-348 2000 mg Experimental

EPB-348 2000 mg dosed once daily for seven days

EPB-348 3000 mg Experimental

EPB-348 3000 mg dosed once daily for seven days

Valacyclovir Active Comparator

Valacyclovir 1000 mg dosed three times daily for seven days

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
No Results Posted