Status:
COMPLETED
Open-label Study of ASP2151 in Herpes Simplex Patients
Lead Sponsor:
Maruho Co., Ltd.
Conditions:
Herpes Simplex
Eligibility:
All Genders
16-79 years
Phase:
PHASE3
Brief Summary
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 vari...
Eligibility Criteria
Inclusion
- 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
- Patients who can start receiving the study drug within 48 hours after onset of rash
- Age: 16 years or older, but younger than 80 years
Exclusion
- Patients who are not expected to have an adequate response to oral antiviral medication.
- Patients with two or more types of herpes simplex.
- 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
- Diagnosis of autoimmune disease
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2015
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT02209324
Start Date
November 1 2013
End Date
August 20 2015
Last Update
September 27 2024
Active Locations (3)
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1
Sapporo Hokkaido Japan
Sapporo, Japan
2
Oota-ku Tokyo Japan
Tokyo, Japan
3
Yokohama Kanagawa Japan
Yokohama, Japan