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

NCT ID: NCT00831103

Last Updated: 2013-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

373 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Herpes Zoster

Keywords

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EPB348 Valomaciclovir Stearate Valacyclovir Herpes Zoster Shingles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EPB-348 1000 mg

EPB-348 1000 mg dosed once daily for seven days

Group Type EXPERIMENTAL

EPB-348

Intervention Type DRUG

Treated over seven days

EPB-348 2000 mg

EPB-348 2000 mg dosed once daily for seven days

Group Type EXPERIMENTAL

EPB-348

Intervention Type DRUG

Treated over seven days

EPB-348 3000 mg

EPB-348 3000 mg dosed once daily for seven days

Group Type EXPERIMENTAL

EPB-348

Intervention Type DRUG

Treated over seven days

Valacyclovir

Valacyclovir 1000 mg dosed three times daily for seven days

Group Type ACTIVE_COMPARATOR

Valacyclovir

Intervention Type DRUG

Treated over seven days

Interventions

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EPB-348

Treated over seven days

Intervention Type DRUG

Valacyclovir

Treated over seven days

Intervention Type DRUG

Other Intervention Names

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Valomaciclovir Stearate Valtrex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Epiphany Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen K Tyring, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center, Houston, Texas

Locations

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Center for Clinical Studies-Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22711350 (View on PubMed)

Other Identifiers

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EPB348-0201

Identifier Type: -

Identifier Source: org_study_id