NCT00486200已完成2 期
A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 695
- 主要终点
- To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection
研究概览
简要总结
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.
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
- •Subject has a history of genital HSV documented by laboratory testing at screening
- •Subject has experienced 4 or more episodes of genital herpes during the past 12 months
排除标准
- •Subject is immunocompromised
研究组 & 干预措施
1
Active Comparator
Oral administration of active comparator
干预措施: valacyclovir (Drug)
2
Placebo Comparator
Oral administration of placebo
干预措施: Placebo (Drug)
3
Experimental
Dosing regimen 1
干预措施: ASP2151 (Drug)
4
Experimental
Dosing regimen 2
干预措施: ASP2151 (Drug)
5
Experimental
Dosing regimen 3
干预措施: ASP2151 (Drug)
6
Experimental
Dosing regimen 4
干预措施: ASP2151 (Drug)
结局指标
主要结局
To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection
时间窗: 17 days
次要结局
- Pharmacokinetics in study patients(4 days)
研究者
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