Phase III Study of ASP2151 in Herpes Zoster Patients- A Double-blind, Valaciclovir-controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 751
- 主要终点
- The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment
研究概览
简要总结
To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.
详细描述
A double-blind, randomized, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster. The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving cessation of new lesion formation by Day 4 of study treatment" to demonstrate the non-inferiority of ASP2151 to VACV. 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
- •(1) Patients who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash
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 < 50 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(400mg)
once daily
干预措施: ASP2151 (Drug)
valaciclovir
1000 mg three times daily
干预措施: valaciclovir (Drug)
ASP2151(200 mg)
once daily
干预措施: ASP2151 (Drug)
结局指标
主要结局
The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment
时间窗: 4days
The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The "new lesion formation" was defined as the state in which the number of rashes is increasing.
次要结局
- Time to Cessation of New Lesion Formation(29days)
- Time to Pain Resolution(29days)
- Time to Complete Crusting(29days)
- Time to Virus Disappearance(29days)
- Time to Healing(29days)