Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

EPB348-0201


NCT ID:

NCT00831103


Secondary ID:


Study Acronym:


Brief Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Epiphany Biosciences


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

373


Enrollment Type:

Actual


Overall Contact Information

Official Name:Stephen K Tyring, MD
Principal Investigator
University of Texas Health Science Center, Houston, Texas

Study Dates

Start Date:November 2007
Completion Date:June 2009
Completion Type:Actual
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:December 2013
Last Changed Date:December 3, 2013
First Received Date:January 26, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm.
Time Frame:Daily assessment during the seven days of treament then weekly until Day 28
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:EPB-348
Description:Treated over seven days
Arm Name:EPB-348 1000 mg
Other Name:Valomaciclovir Stearate
Intervention Type:Drug
Name:Valacyclovir
Description:Treated over seven days
Arm Name:Valacyclovir
Other Name:Valtrex

Study Arms

Study Arm Type:Active Comparator
Arm Name:Valacyclovir
Description:Valacyclovir 1000 mg dosed three times daily for seven days
Study Arm Type:Experimental
Arm Name:EPB-348 3000 mg
Description:EPB-348 3000 mg dosed once daily for seven days
Study Arm Type:Experimental
Arm Name:EPB-348 2000 mg
Description:EPB-348 2000 mg dosed once daily for seven days
Study Arm Type:Experimental
Arm Name:EPB-348 1000 mg
Description:EPB-348 1000 mg dosed once daily for seven days

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Epiphany Biosciences

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:22711350

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.