JPRN-jRCT2080224870已完成3 期
Phase III, Placebo-controlled, Randomized, Double-blind, Multicenter, Parallel-group comparative study to Evaluate the Efficacy and Safety of Patient Initiated Therapy of ASP2151 in Patients with Recurrent Herpes Labialis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,804
研究概览
简要总结
In this study, a single dose of ASP2151 1200 mg significantly shortened the time to all lesion healing of recurrent herpes labialis over placebo. Amenamevir was well tolerated and showed no clinically major safety concerns.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •Recurrent Herpes Labialis patients
排除标准
- •(1)Patients diagnosed with immunodeficiency or
- •immunocompromised function (such as patients with congenital immunodeficiency, AIDS patients, patients with HIV infection)
- •(2)Patients with any disorders that should not be enrolled in the sutdy such as;
- •-severe cardiac disorders
- •-severe hepatic disorders
- •-severe pulmonary disorders
- •-severe blood disorders
- •(3)Pregnant women, women who may be pregnant, lactating women or women who wish to become pregnant or women who are unwilling to use a suitable method of contraception as directed by the principal investigator or sub-investigator.
研究者
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