Phase 3
N=751
Phase III Study of ASP2151 in Herpes Zoster Patients
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT01959841 ↗Enrolled (actual)
751
Serious AEs
0.7%
Results posted
Oct 2018
Primary outcome: Primary: The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment — 69.6; 81.1; 75.1 percentage of Participants — p=0.00000241
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ASP2151 (Drug); valaciclovir (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Maruho Co., Ltd.
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment |
69.6; 81.1; 75.1 | 0.00000241 sig |
| SECONDARY Time to Cessation of New Lesion Formation |
4; 4; 4 | — |
| SECONDARY Time to Complete Crusting |
8; 9; 8 | — |
| SECONDARY Time to Healing |
11; 11; 11 | — |
| SECONDARY Time to Pain Resolution |
9; 10; 10 | — |
| SECONDARY Time to Virus Disappearance |
4; 5; 4 | — |
Summary
To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.
Eligibility Criteria
Inclusion Criteria
(1) Patients who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash
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 < 50 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 (NCT01959841). 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.