Open-label Study of ASP2151 in Herpes Simplex Patients

Maruho

Status and phase: Completed; Phase 3

Conditions: Herpes Simplex

Treatments: Drug: ASP2151

Study type: Interventional

Funder types: Industry

Identifiers

NCT02209324

M522101-J12

Details and patient eligibility

About

A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes and Kaposi varicelliform).

Enrollment: 275 patients

Sex: All

Ages: 16 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with a rash associated with herpes simplex and a recurrent episode meeting the following criteria

   • Recurrent labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
   • Recurrent genital herpes: Patients with at least 5 papules or vesicles/pustules on the genital organs or in the genital and circumanal region
   • Kaposi varicelliform eruption: Patients with major skin symptoms of papulae or vesicles

2. Patients who can start receiving the study drug within 48 hours after onset of rash

3. Age: 16 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. Patients with two or more types of herpes simplex.

3. An extreme decline in immune function

4. Presence of serious complications

5. 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

6. Current or previous history of malignant tumor within 5 years before informed consent

7. Diagnosis of autoimmune disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

275 participants in 1 patient group

ASP2151

Experimental group

Treatment:

Drug: ASP2151