Phase 3
N=468
Phase III Study of ASP2151 in Herpes Simplex Patients
Herpes Simplex
Bottom Line
View on ClinicalTrials.gov: NCT01959295 ↗Enrolled (actual)
468
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Percentage of Participants With Healing by Day 8 — 66.4; 69.5 Percentage of Participants — p=0.5086
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ASP2151 (Drug); ASP2151 placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Maruho Co., Ltd.
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Healing by Day 8 |
66.4; 69.5 | 0.5086 |
| SECONDARY Time to Healing |
8; 8 | — |
| SECONDARY Time to Complete Crusting |
6; 6 | — |
| SECONDARY Time to Virus Disappearance |
4; 5 | — |
Summary
To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.
Eligibility Criteria
Inclusion Criteria
- 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
- Patients who can start receiving the study drug within 48 hours after onset of rash
- Age: 20 years or older, but younger than 80 years
Exclusion Criteria
- Patients who are not expected to have an adequate response to oral antiviral medication
- 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
- Evidence of bone marrow suppression
Data sourced from ClinicalTrials.gov (NCT01959295). 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.