JPRN-jRCT2080222573CompletedPhase 3
Open-label Study of ASP2151 in Herpes Simplex Patients
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Maruho Co.,Ltd.
- Enrollment
- 275
Study Overview
Brief Summary
This study demonstrated the efficacy of ASP2151 for herpes simplex (recurrent labial/facial herpes, recurrent genital herpes, and Kaposi varicelliform eruption). With regard to safety, all adverse events related to the study drug were mild in severity, indicating that ASP2151 would pose no clinically significant safety concerns.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 16age old to <= 79age old (—)
- Sex
- All
Inclusion Criteria
- •(1) Patients with a rash associated with herpes simplex and a recurrent episode meeting the following criteria
- •1)Recurrent labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
- •2)Recurrent genital herpes: Patients with at least 5 papules or vesicles/pustules on the genital organs or in the genital and circumanal region
- •3)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
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:
- •1) AST or ALT > 2.5 x upper limit of normal
- •2)Platelet count < lower limit of normal
- •3)Serum creatinine > 1.5 mg/dL
- •4)Creatinine clearance < 30 mL/min
- •(6) Current or previous history of malignant tumor within 5 years before informed consent
- •(7) Diagnosis of autoimmune disease
Investigators
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