Phase III Study of ASP2151 in Herpes Simplex Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Maruho Co., Ltd.

Criteria

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