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Open-label Study of ASP2151 in Herpes Simplex Patients

Primary Purpose

Herpes Simplex

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

ASP2151

About this trial

This is an interventional treatment trial for Herpes Simplex

Eligibility Criteria

16 Years - 79 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Patients who can start receiving the study drug within 48 hours after onset of rash
Age: 16 years or older, but younger than 80 years

Exclusion Criteria:

Patients who are not expected to have an adequate response to oral antiviral medication.
Patients with two or more types of herpes simplex.
An extreme decline in immune function
Presence of serious complications
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
Current or previous history of malignant tumor within 5 years before informed consent
Diagnosis of autoimmune disease

Sites / Locations

Sapporo Hokkaido Japan
Oota-ku Tokyo Japan
Yokohama Kanagawa Japan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASP2151

Arm Description

Outcomes

Primary Outcome Measures

The proportion of subjects achieving lesion healing by Day 8 of study treatment

Secondary Outcome Measures

Time to healing

Time to complete crusting

Time to virus disappearance

Full Information

NCT ID

NCT02209324

First Posted

July 31, 2014

Last Updated

March 15, 2016

Sponsor

Maruho Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02209324

Brief Title

Open-label Study of ASP2151 in Herpes Simplex Patients

Official Title

Open-label Study of ASP2151 in Herpes Simplex Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maruho Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Simplex

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ASP2151

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ASP2151

Other Intervention Name(s)

200 mg once daily

Primary Outcome Measure Information:

Title

The proportion of subjects achieving lesion healing by Day 8 of study treatment

Time Frame

8 days

Secondary Outcome Measure Information:

Title

Time to healing

Time Frame

29 days

Title

Time to complete crusting

Time Frame

29 days

Title

Time to virus disappearance

Time Frame

29 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Patients who can start receiving the study drug within 48 hours after onset of rash Age: 16 years or older, but younger than 80 years Exclusion Criteria: Patients who are not expected to have an adequate response to oral antiviral medication. Patients with two or more types of herpes simplex. An extreme decline in immune function Presence of serious complications 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 Current or previous history of malignant tumor within 5 years before informed consent Diagnosis of autoimmune disease

Facility Information:

Facility Name

Sapporo Hokkaido Japan

City

Sapporo

Country

Japan

Facility Name

Oota-ku Tokyo Japan

City

Tokyo

Country

Japan

Facility Name

Yokohama Kanagawa Japan

City

Yokohama

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Open-label Study of ASP2151 in Herpes Simplex Patients

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