Clinical trial NCT00831103: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Zoster
Keywords: EPB348
Valomaciclovir Stearate
Valacyclovir
Herpes Zoster
Shingles
Lead sponsor: Epiphany Biosciences
Sponsor class: INDUSTRY
First posted: 2009-01-28
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm.
timeFrame: Daily assessment during the seven days of treament then weekly until Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Center for Clinical Studies-Medical Center
state: Texas
Study officials:
affiliation: University of Texas Health Science Center, Houston, Texas
name: Stephen K Tyring, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.