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

Not Applicable

• Conditions: Recurrent herpes simplex; D006561

• Registration Number: JPRN-jRCT1031210377
• Lead Sponsor: Hayakawa Jun

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1) QOL at the time of recurrence of herpes simplex under administration for 5 days (at the time of registration)<br>(2) QOL at the time of recurrence of herpes simplex under PIT prescription<br>(3) QOL at the time of non-recurrence<br>(4) Changes in internal criteria for QOL at the time of recurrence of herpes simplex under administration for 5 days (at the time of registration)<br>Response shift