Status:
COMPLETED
A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster
Lead Sponsor:
Epiphany Biosciences
Conditions:
Herpes Zoster
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT00831103
Start Date
November 1 2007
End Date
June 1 2009
Last Update
December 5 2013
Active Locations (1)
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1
Center for Clinical Studies-Medical Center
Houston, Texas, United States, 77030