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
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