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Phase III Study of ASP2151 in Herpes Simplex Patients

Primary Purpose

Herpes Simplex

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

ASP2151

ASP2151 placebo

About this trial

This is an interventional treatment trial for Herpes Simplex

Eligibility Criteria

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

Inclusion Criteria:

Patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated
- Labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
- Recurrent genital herpes: Patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region
Patients who can start receiving the study drug within 48 hours after onset of rash
Age: 20 years or older, but younger than 80 years

Exclusion Criteria:

Patients who are not expected to have an adequate response to oral antiviral medication
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
Evidence of bone marrow suppression

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASP2151

ASP2151 placebo

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

NCT01959295

First Posted

September 26, 2013

Last Updated

March 15, 2016

Sponsor

Maruho Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01959295

Brief Title

Phase III Study of ASP2151 in Herpes Simplex Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

April 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

5. Study Description

Brief Summary

To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.

Detailed Description

A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment" to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.

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

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

453 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ASP2151

Arm Type

Experimental

Arm Title

ASP2151 placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ASP2151

Intervention Description

200 mg once daily

Intervention Type

Drug

Intervention Name(s)

ASP2151 placebo

Intervention Description

once daily

Primary Outcome Measure Information:

Title

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

Time Frame

8days

Secondary Outcome Measure Information:

Title

Time to healing

Time Frame

29days

Title

Time to complete crusting

Time Frame

29days

Title

Time to virus disappearance

Time Frame

29days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated Labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules Recurrent genital herpes: Patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region Patients who can start receiving the study drug within 48 hours after onset of rash Age: 20 years or older, but younger than 80 years Exclusion Criteria: Patients who are not expected to have an adequate response to oral antiviral medication 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 Evidence of bone marrow suppression

Facility Information:

City

Sapporo

State/Province

Hokkaido

Country

Japan

City

Yokohama

State/Province

Kanagawa

Country

Japan

City

Nakano-ku

State/Province

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Phase III Study of ASP2151 in Herpes Simplex Patients

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