Phase III Study of ASP2151 in Herpes Zoster Patients

• Status: Completed
• Trial end date: 2015-07-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maruho Co., Ltd.
• Treatments: Acyclovir; Valacyclovir

Criteria

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