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Observational Study on the Use of Antiviral Agents for Herpes Zoster and Their Association with Encephalopathy and Other Patient Outcomes

Evaluation of the Association Between Antiviral Agents for Herpes Zoster and Encephalopathy or Other Outcomes Using the JADER Database and Real-World Cases - Zoster Outcomes and Antivirals Safety Study (ZASS)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000058371
Enrollment
1000
Registered
2025-08-01
Start date
2025-03-01
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, Encephalopathy, Meningitis

Interventions

None listed

Sponsors

Aisei Pharmacy Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with herpes zoster who were prescribed antiviral agents (amenamevir, acyclovir, valacyclovir, or famciclovir) Antiviral therapy lasting at least 7 days Adverse events (encephalopathy or herpes zoster exacerbation) occurring within 3 months after the first dose Availability of patient background information such as age, sex, and comorbidities

Exclusion criteria

Exclusion criteria: Patients who received antiviral therapy for indications other than herpes zoster. Lost to follow up Cases in which adverse event outcomes cannot be confirmed within 3 months after the initial prescription. Patients with a prior history of encephalopathy or meningitis before antiviral use. Cases in which adverse events are clearly attributable to other drugs. Patients receiving immunosuppressive agents. Patients with marked immunosuppression, such as those post bone marrow or organ transplantation.

Design outcomes

Primary

MeasureTime frame
Frequency of encephalopathy after antiviral drug administration based on the JADER database and pharmacy case data

Secondary

MeasureTime frame
Frequency of herpes zoster exacerbation Association of drug type, duration, and co-medications with encephalopathy onset Impact of differences in cerebrospinal fluid penetration on patient outcomes

Countries

Japan

Contacts

Public ContactShingo Nemoto

Aisei Pharmacy Co., Ltd. Kanagawa Branch

sentaminami@aisei.co.jp03-3240-0222

Outcome results

None listed

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