Phase III Study of ASP2151 in Herpes Simplex Patients

NCT ID: NCT01959295

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-04-27

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.

Conditions

Herpes Simplex

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ASP2151

Group Type: EXPERIMENTAL

ASP2151

Intervention Type: DRUG

200 mg once daily

ASP2151 placebo

Group Type: PLACEBO_COMPARATOR

ASP2151 placebo

Intervention Type: DRUG

once daily

Interventions

ASP2151

200 mg once daily

Intervention Type: DRUG

ASP2151 placebo

once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

2. Patients who can start receiving the study drug within 48 hours after onset of rash

3. Age: 20 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. An extreme decline in immune function

3. Presence of serious complications

4. 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

5. Current or previous history of malignant tumor within 5 years before informed consent

6. Diagnosis of autoimmune disease

7. Evidence of bone marrow suppression

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maruho Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sapporo, Hokkaido, Japan

Yokohama, Kanagawa, Japan

Nakano-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

M522101-J11

Identifier Type: -

Identifier Source: org_study_id