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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Epiphany Biosciences
• Treatments: Acyclovir; Valacyclovir

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