Open-label Study of ASP2151 in Herpes Simplex Patients

Herpes Simplex Clinical Trial

Official title:

Open-label Study of ASP2151 in Herpes Simplex Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209324
• Other study ID #: M522101-J12
• Status: Completed
• Phase: Phase 3
• First received: July 31, 2014
• Last updated: March 15, 2016
• Start date: November 2013

Study information

• Verified date: March 2016
• Source: Maruho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes and Kaposi varicelliform).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Patients with a rash associated with herpes simplex and a recurrent episode meeting the following criteria

• Recurrent labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules

• Recurrent genital herpes: Patients with at least 5 papules or vesicles/pustules on the genital organs or in the genital and circumanal region

• 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

3. Age: 16 years or older, but younger than 80 years

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:

• AST or ALT = 2.5 x upper limit of normal

• Platelet count < lower limit of normal

• Serum creatinine = 1.5 mg/dL

• 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex

Intervention

Drug:
• ASP2151

Locations

Country	Name	City	State
Japan	Sapporo Hokkaido Japan	Sapporo
Japan	Oota-ku Tokyo Japan	Tokyo
Japan	Yokohama Kanagawa Japan	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Maruho Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects achieving lesion healing by Day 8 of study treatment		8 days	No
Secondary	Time to healing		29 days	No
Secondary	Time to complete crusting		29 days	No
Secondary	Time to virus disappearance		29 days	No