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Phase 3 Study of ASP2151 in Herpes Zoster Patients - A Double-blind,Valaciclovir-controlled Study -

Phase 3 Study of ASP2151 in Herpes Zoster Patients - A Double-blind,Valaciclovir-controlled Study -

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222242
Enrollment
750
Registered
2013-10-02
Start date
2013-10-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

herpes zoster

Interventions

investigational material(s) Generic name etc : ASP2151 INN of investigational material : Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : 200

Sponsors

Maruho Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

Exclusion criteria: (1) Patients who are not expected to have an adequate response to oral antiviral medication (2) An extreme decline in immune function (3) Presence of serious complications (4) 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 = 1.5 mg/dL 4) Creatinine clearance < 50 mL/min (5) Current or previous history of malignant tumor within 5 years before informed consent (6) Diagnosis of autoimmune disease (7) Evidence of bone marrow suppression

Design outcomes

Primary

MeasureTime frame
The proportion of subjects achieving cessation of new lesion formation by Day 4 of study treatment

Secondary

MeasureTime frame
Time to cessation of new lesion formation, time to complete crusting, time to healing, time to pain resolution, and time to virus disappearance

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026