Phase 3 Study of ASP2151 in Herpes Simplex Patients -A Double-blind,Placebo-controlled Study

Phase 3

Completed

• Conditions: herpes simplex (labial/facial herpes or recurrent genital herpes)

• Registration Number: JPRN-jRCT2080222243
• Lead Sponsor: Maruho Co.,Ltd.

Brief Summary

In the conditions of this study, ASP2151 was not shown to be effective for herpes simplex. All adverse events were moderate or mild, indicating that ASP2151 would pose no clinically great safety concerns.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-02
• Study Completion: 2015-04-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 468

Inclusion Criteria

(1) Patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated
1)Labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
2)Recurrent genital herpes: Patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region
(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) An extreme decline in immune function
(3) Presence of serious complications
(4) 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
(5) Current or previous history of malignant tumor within 5 years before informed consent
(6) Diagnosis of autoimmune disease
(7) Evidence of bone marrow suppression

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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