Phase 3
N=275
Open-label Study of ASP2151 in Herpes Simplex Patients
Herpes Simplex
Bottom Line
View on ClinicalTrials.gov: NCT02209324 ↗Enrolled (actual)
275
Serious AEs
0.7%
Results posted
Sep 2024
Primary outcome: Primary: Percentage of Participants With Healing by Day 8 — 194 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ASP2151 (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Maruho Co., Ltd.
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Healing by Day 8 |
194 | — |
| SECONDARY Time to Healing |
7 | — |
| SECONDARY Time to Complete Crusting |
6 | — |
| SECONDARY Time to Virus Disappearance |
5 | — |
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 varicelliform).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02209324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.