Phase 3
Completed N=751
Phase III Study of ASP2151 in Herpes Zoster Patients
Source: ClinicalTrials.gov NCT01959841 ↗Enrolled (actual)
751
Serious AEs
0.7%
Results posted
Oct 2018
Primary outcomePrimary: 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
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.