JPRN-jRCT1031210377进行中（未招募）未知
Change in quality of life in the treatment change from 5-day treatment to patient-initiated therapy of anti-herpesvirus drugs in patients with recurrent herpes simplex -Exploratory prospective observational study- - Q-pid study
Hayakawa Jun0 个研究点目标入组 100 人开始时间: 2021年10月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Male or female Japanese subjects, >=20 years old at the time of signing informed consent
- •(2) Subjects who may recur herpes simplex three times or more per year
- •(3) Subjects who can recognize the early symptoms of recurrent herpes simplex (a feeling of strangeness, burning or itching, etc)
- •(4) Subjects who had the early symptoms of herpes simplex or skin rashes for 72 hours or longer
- •(5) Subjects who received the oral anti-herpesvirus agents for 5 days and wish to receive the PIT (patient-initiated therapy) at the next recurrence of herpes simplex
排除标准
- •(1)Any known history of hypersensitivity to the excipient (famciclovir) of the research drug
- •(2)Subjects whose immune response may decrease due to hematopoietic stem cell transplantation, organ transplantation or HIV (human immunodeficiency virus) infection
- •(3) A person who has participated in a clinical study of a vaccine for herpes simplex or herpes zoster.
- •(4) Persons who have participated in clinical research, clinical trials, or post-marketing clinical trials of therapeutic agents for herpes simplex or herpes zoster during the 6 months prior to the date of consent.
- •(5) Those who are participating or have participated in other clinical research, clinical trials or post-marketing clinical trials other than (3) or (4) within 4 months prior to the date of consent.
- •(6)Pregnant women, women of child-bearing potential, or lactating women
- •(7)Subjects or his/her partner who will not use adequate contraceptive methods between the time of signing informed consent and the completion of the research
- •(8)Subjects who have received suppressive treatment for herpes simplex within 6 months before signing informed consent
- •(9)Subjects who are ineligible to participate in this research by the consideration of the principal researcher or sub-researcher
研究者
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