Open-label Study of ASP2151 in Herpes Simplex Patients

NCT ID: NCT02209324

Last Updated: 2024-09-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-08-20

Brief Summary

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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).

Detailed Description

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Conditions

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Herpes Simplex

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASP2151

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

Interventions

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ASP2151

Intervention Type DRUG

Other Intervention Names

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200 mg once daily

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maruho Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sapporo Hokkaido Japan

Sapporo, , Japan

Site Status

Oota-ku Tokyo Japan

Tokyo, , Japan

Site Status

Yokohama Kanagawa Japan

Yokohama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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M522101-J12

Identifier Type: -

Identifier Source: org_study_id

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