A Phase 2b Trial of EPB-348 for the Treatment of Herpes Zoster
Completed · Phase 2
Conditions studied: Herpes Zoster
In brief
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.
Key facts
- Study ID
- NCT00831103
- Run by
- Epiphany Biosciences
- People needed
- 373
- Starts
- 2007-11-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2013-12-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Center for Clinical Studies-Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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