Phase III Study of ASP2151 in Herpes Simplex Patients

Maruho

Status and phase: Completed; Phase 3

Conditions: Herpes Simplex

Treatments: Drug: ASP2151; Drug: ASP2151 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959295

M522101-J11

Details and patient eligibility

About

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

Full 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.

Enrollment: 468 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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468 participants in 2 patient groups, including a placebo group

ASP2151

Experimental group

Treatment:

Drug: ASP2151

ASP2151 placebo

Placebo Comparator group

Treatment:

Drug: ASP2151 placebo