Open-label Study of ASP2151 in Herpes Simplex Patients

Phase 3CompletedNCT02209324

Maruho Co., Ltd.275 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

275

Conditions

Herpes Simplex

Interventions

ASP2151DRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (3)

Sapporo Hokkaido Japan

Sapporo, Japan

Oota-ku Tokyo Japan

Tokyo, Japan

Yokohama Kanagawa Japan

Yokohama, Japan

Outcomes

Primary Outcomes

Percentage of Participants With Healing by Day 8

The percentage of participants achieving lesion healing by Day 8 of study treatment

Time frame: 8 days

Secondary Outcomes

Time to Healing

The criteria for determining healing are as follows: 1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and either the complete resolution of crusts or the complete epithelialization beneath any remaining crusts has been achieved. 2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas. 3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.

Time frame: 29 days

Time to Complete Crusting

The criteria for complete crust formation are outlined as follows: 1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and all rashes are crusted (epithelialization beneath is not required). 2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas. 3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.

Time frame: 29 days

Time to Virus Disappearance

The day of viral disappearance is the first day on which the results of viral isolation continuously show 'HSV negative' until the final implementation day. The negative means that the results of the isolation and culture are negative, or the isolation and culture has not been performed due to complete crusting or healing of the lesion site.

Time frame: 29 days

Data from ClinicalTrials.gov

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