Open-label Study of ASP2151 in Herpes Simplex Patients

Phase 3

Completed

• Conditions: Recurrent herpes simplex (labial/facial herpes and recurrent genital herpes) and Kaposi varicelliform eruption

• Registration Number: JPRN-jRCT2080222573
• Lead Sponsor: Maruho Co.,Ltd.

Brief Summary

This study demonstrated the efficacy of ASP2151 for herpes simplex (recurrent labial/facial herpes, recurrent genital herpes, and Kaposi varicelliform eruption). With regard to safety, all adverse events related to the study drug were mild in severity, indicating that ASP2151 would pose no clinically significant safety concerns.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-04
• Study Completion: 2015-08-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

(1) Patients with a rash associated with herpes simplex and a recurrent episode meeting the following criteria
1)Recurrent labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
2)Recurrent genital herpes: Patients with at least 5 papules or vesicles/pustules on the genital organs or in the genital and circumanal region
3)Kaposi varicelliform eruption: Patients with major skin symptoms of papulae or vesicles
(2) Patients who can start receiving the study drug within 48 hours after onset of rash

Exclusion Criteria

(1) Patients who are not expected to have an adequate response to oral antiviral medication.
(2) Patients with two or more types of herpes simplex.
(3) An extreme decline in immune function
(4) Presence of serious complications
(5) Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:
1) AST or ALT > 2.5 x upper limit of normal
2)Platelet count < lower limit of normal
3)Serum creatinine > 1.5 mg/dL
4)Creatinine clearance < 30 mL/min
(6) Current or previous history of malignant tumor within 5 years before informed consent
(7) Diagnosis of autoimmune disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>The proportion of subjects achieving lesion healing by Day 8 of study treatment

Secondary Outcome Measures

Name	Time	Method
efficacy<br>Time to healing, time to complete crusting, and time to virus disappearance