Phase III Study of ASP2151 in Herpes Zoster Patients
Phase III Study of ASP2151 in Herpes Zoster Patients
To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with
 valaciclovir (VACV) 3000 mg in patients with herpes zoster.
A double-blind, randomized, parallel-group study will be conducted to evaluate the efficacy
 and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in
 patients with herpes zoster. The efficacy will be evaluated for the primary endpoint defined
 as, "the proportion of subjects achieving cessation of new lesion formation by Day 4 of study
 treatment" to demonstrate the non-inferiority of ASP2151 to VACV. The safety will be
 evaluated based on adverse events, laboratory tests, vital signs, and ECGs.
Inclusion Criteria:

 (1) Patients who have a rash associated with herpes zoster, and who can start receiving the
 study drug within 72 hours after onset of the rash

 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 < 50 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