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

Information source: Epiphany Biosciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Zoster

Intervention: EPB-348 (Drug); Valacyclovir (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Epiphany Biosciences

Official(s) and/or principal investigator(s):
Stephen K Tyring, MD, Principal Investigator, Affiliation: University of Texas Health Science Center, Houston, Texas

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.

Clinical Details

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

Primary outcome: To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Center for Clinical Studies-Medical Center, Houston, Texas 77030, United States
Additional Information

Starting date: November 2007
Last updated: December 3, 2013

Page last updated: August 23, 2015

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