Phase III Study of ASP2151 in Herpes Simplex Patients - A Double-blind, Placebo-controlled Study -
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 468
- 主要终点
- Percentage of Participants With Healing by Day 8
研究概览
简要总结
To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.
详细描述
A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment" to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated
- •Labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
- •Recurrent genital herpes: Patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region
- •Patients who can start receiving the study drug within 48 hours after onset of rash
- •Age: 20 years or older, but younger than 80 years
排除标准
- •Patients who are not expected to have an adequate response to oral antiviral medication
- •An extreme decline in immune function
- •Presence of serious complications
- •Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:
- •AST or ALT ≥ 2.5 x upper limit of normal
- •Platelet count < lower limit of normal
- •Serum creatinine ≥ 1.5 mg/dL
- •Creatinine clearance < 30 mL/min
- •Current or previous history of malignant tumor within 5 years before informed consent
- •Diagnosis of autoimmune disease
- •Evidence of bone marrow suppression
研究组 & 干预措施
ASP2151
干预措施: ASP2151 (Drug)
ASP2151 placebo
干预措施: ASP2151 placebo (Drug)
结局指标
主要结局
Percentage of Participants With Healing by Day 8
时间窗: 8days
The percentage of participants achieving lesion healing by Day 8 of study treatment
次要结局
- Time to Healing(29days)
- Time to Complete Crusting(29days)
- Time to Virus Disappearance(29days)