Retrospective cohort study to assess changes in recurrence frequency by Patient initiated therapy (PIT) for recurrent herpes simplex

JRCT ID: jRCT1031230671

Registered date:29/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Recurrent herpes simplex (recurrent labial and facial herpes, recurrent genital herpes)
• Date of first enrollment: 29/02/2024
• Target sample size: 50
• Study type: Observational

Outcome(s)

• Primary Outcome: Comparison of number of recurrences (times/year) during period 1 and the first year of period 2
• Secondary Outcome: Comparison of number of recurrences (time/year) during the first year and the second year of period 2(In Period 2, only pacients who have been observed for 2-year or longer)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Men and women >= 18 years old at the time of registration*1
(2) Patients who have a history of outpatient visits to the research institution for treatment of recurrent herpes simplex (recurrent herpes on the lips and face, recurrent genital herpes)
(3) Patients who have continued 5-day treatment with oral antiherpes virus drugs for one year or more for the treatment of recurrent herpes simplex
(4) Patients whose treatment method was changed from 5-day treatment with oral antiherpes virus drugs to PIT treatment with famciclovir at the research institution
(5) Patients who have continued Famciclovir PIT treatment at a research institution for one year or more
(6) Patients who have consecutive treatment periods for (3) and (5)
(7) Patients who can confirm the number of recurrences of recurrent herpes simplex in the past one year from the time of registration
(8) Patients whose annual number of recurrences of recurrent herpes simplex during the period of PIT can be confirmed
(9) Patients who did not indicate their refusal to opt-out
*1 The date when famciclovir was first prescribed to the target patient for PIT

• Exclude criteria: Paciants judged to be inappropriate by the principal investigator

Related Information

• Primary Sponsor: Sugai Junichi
• Source(s) of Monetary Support: Maruho Co., Ltd.