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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 373
- 试验地点
- 1
- 主要终点
- To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
EPB-348 1000 mg
EPB-348 1000 mg dosed once daily for seven days
干预措施: EPB-348 (Drug)
EPB-348 2000 mg
EPB-348 2000 mg dosed once daily for seven days
干预措施: EPB-348 (Drug)
EPB-348 3000 mg
EPB-348 3000 mg dosed once daily for seven days
干预措施: EPB-348 (Drug)
Valacyclovir
Valacyclovir 1000 mg dosed three times daily for seven days
干预措施: Valacyclovir (Drug)
结局指标
主要结局
To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm.
时间窗: Daily assessment during the seven days of treament then weekly until Day 28
次要结局
未报告次要终点