Phase III Study of ASP2151 in Herpes Simplex Patients
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To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.
Condition or disease
Drug: ASP2151Drug: ASP2151 placebo
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.
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Layout table for eligibility information
Ages Eligible for Study:
20 Years to 79 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Patients who can start receiving the study drug within 48 hours after onset of rash
Age: 20 years or older, but younger than 80 years
Patients who are not expected to have an adequate response to oral antiviral medication
An extreme decline in immune function
Presence of serious complications
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
Current or previous history of malignant tumor within 5 years before informed consent