Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:49 PM
Study NCT ID:
NCT00831103
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2009-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077483', 'term': 'Valacyclovir'}], 'ancestors': [{'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 373}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2009-01-26', 'studyFirstSubmitQcDate': '2009-01-26', 'lastUpdatePostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['EPB348', 'Valomaciclovir Stearate', 'Valacyclovir', 'Herpes Zoster', 'Shingles'], 'conditions': ['Herpes Zoster']}, 'referencesModule': {'references': [{'pmid': '22711350', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adults at least 18 years of age\n* 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\n* Herpes Zoster associated rash present for ≤ 72 hours\n* Patients who are deemed to be immunocompetent based on history and physical exam\n\nExclusion Criteria:\n\n* Females who are pregnant or nursing\n* 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\n* Chronic genital herpes\n* Patients who received cytotoxic or immunosuppressive drug therapy within 3 months prior to study participation\n* Previous vaccinations against Herpes Zoster\n* Patients with \\> 50% of vesicles crusted at screen\n* Patients who received topical or systemic antiviral medications or immunomodulatory agents for herpes zoster viral infections or capsaicin within 4 weeks of study participation\n* 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)\n* QTc \\> 500msec\n* Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, or famciclovir\n* Patients with gastrointestinal dysfunction that might interfere with drug absorption\n* Patients, considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug'}, 'identificationModule': {'nctId': 'NCT00831103', 'briefTitle': 'A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epiphany Biosciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EPB348-0201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EPB-348 1000 mg', 'description': 'EPB-348 1000 mg dosed once daily for seven days', 'interventionNames': ['Drug: EPB-348']}, {'type': 'EXPERIMENTAL', 'label': 'EPB-348 2000 mg', 'description': 'EPB-348 2000 mg dosed once daily for seven days', 'interventionNames': ['Drug: EPB-348']}, {'type': 'EXPERIMENTAL', 'label': 'EPB-348 3000 mg', 'description': 'EPB-348 3000 mg dosed once daily for seven days', 'interventionNames': ['Drug: EPB-348']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Valacyclovir', 'description': 'Valacyclovir 1000 mg dosed three times daily for seven days', 'interventionNames': ['Drug: Valacyclovir']}], 'interventions': [{'name': 'EPB-348', 'type': 'DRUG', 'otherNames': ['Valomaciclovir Stearate'], 'description': 'Treated over seven days', 'armGroupLabels': ['EPB-348 1000 mg', 'EPB-348 2000 mg', 'EPB-348 3000 mg']}, {'name': 'Valacyclovir', 'type': 'DRUG', 'otherNames': ['Valtrex'], 'description': 'Treated over seven days', 'armGroupLabels': ['Valacyclovir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Clinical Studies-Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Stephen K Tyring, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Health Science Center, Houston, Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epiphany Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}