Phase III Study of AK-120 in Patients with Recurrent Herpes Simplex

Phase 3

Completed

• Conditions: Recurrent Herpes Simplex (recurrent herpes labialis and recurrent genital herpes)

• Registration Number: JPRN-jRCT2080223168
• Lead Sponsor: Maruho Co.,Ltd.

Brief Summary

The superiority of the FCV group to the placebo group was verified for the primary endpoint. The results from the secondary endpoints supported the results from the primary endpoint, confirming the efficacy of early short-duration treatment with FCV for recurrent herpes simplex. In terms of safety, all adverse events that occurred were mild in severity, and there were no clinically significant adverse events associated with the administration of FCV.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-08
• Study Completion: 2017-07-13
• Results First Posted: 2018-04-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 531

Inclusion Criteria

Patients with Recurrent Herpes Simplex

Exclusion Criteria

(1)Patients diagnosed with immunodeficiency or immunocompromised function (such as patients with congenital immunodeficiency, AIDS patients, patients with HIV infection)
(2)Patients who have received organ transplants or bone marrow transplants
(3)Patients with a history of renal impairment, patients with potential renal impairment, or patients with renal impairment
(4)Patients with any disorders that should not be enrolled in the study such as;
-severe cardiac disorders
-severe hepatic disorders
-severe pulmonary disorders
-severe gastrointestinal disorders
-severe blood disorders
(5)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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
exploratory<br>efficacy<br>Time to healing of all herpes simplex lesions<br>The principal investigator or sub-investigator will observe all lesional sites at each evaluation time point to assess whether the lesions have healed and if so, the time and date of healing is determined.

Secondary Outcome Measures

Name	Time	Method
efficacy<br>(1)Time to cessation of viral shedding at the herpes simplex lesions<br><br>(1)First viral sampling date and time that all subsequent viral cultures are confirmed as negative, or first consultation date and time that viral sampling is not possible because of crusting or epithelialization.<br><br>efficacy<br>(2)Time to complete crusting of all herpes simplex lesions<br><br>(2)The principal investigator or sub-investigator will observe all lesional sites at each evaluation time point to assess whether all lesions have crusted and if so, the time and date of full crusting is determined.