Phase III Study of ASP2151 in Herpes Simplex Patients

Herpes Simplex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959295
• Other study ID #: M522101-J11
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2013
• Last updated: March 15, 2016
• Start date: August 2013

Study information

• Verified date: March 2016
• Source: Maruho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Herpes Simplex

Intervention

Drug:
• ASP2151
200 mg once daily
• ASP2151 placebo
once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maruho Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects achieving lesion healing by Day 8 of study treatment		8days	No
Secondary	Time to healing		29days	No
Secondary	Time to complete crusting		29days	No
Secondary	Time to virus disappearance		29days	No