Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058371) titled 'Observational Study on the Use of Antiviral Agents for Herpes Zoster and Their Association with Encephalopathy and Other Patient Outcomes' on Aug. 1.

Study Type: Observational

Primary Sponsor: Institute - Aisei Pharmacy Co., Ltd.

Condition: Condition - Herpes zoster, Encephalopathy, Meningitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the association between amenamevir or conventional antiviral agents and encephalopathy or exacerbation of herpes zoster using the JADER database and pharmacy case data. Basic objectives2 - Safety

Eligibility: Age-lower limit - 10 years-old = Gender - Male and Female Key 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 Key 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. Target Size - 1000

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 02 Month 01 Day Date of IRB - 2025 Year 02 Month 28 Day Anticipated trial start date - 2025 Year 03 Month 01 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066732

Disclaimer: Curated by HT Syndication.