JPRN-jRCT1031210377
Active, not recruiting
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 sites100 target enrollmentOctober 14, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Recurrent herpes simplex
- Sponsor
- Hayakawa Jun
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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
Exclusion Criteria
- •(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
Outcomes
Primary Outcomes
Not specified
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