UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058371 |
|---|---|
| Receipt number | R000066732 |
| Scientific Title | Evaluation of the Association Between Antiviral Agents for Herpes Zoster and Encephalopathy or Other Outcomes Using the JADER Database and Real-World Cases |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/05 09:58:02 |
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Basic information
Public title
Observational Study on the Use of Antiviral Agents for Herpes Zoster and Their Association with Encephalopathy and Other Patient Outcomes
Acronym
Zoster-Antiviral Safety Study (ZASS)
Scientific Title
Evaluation of the Association Between Antiviral Agents for Herpes Zoster and Encephalopathy or Other Outcomes Using the JADER Database and Real-World Cases
Scientific Title:Acronym
Zoster Outcomes and Antivirals Safety Study (ZASS)
Region
| Japan |
Condition
Condition
Herpes zoster, Encephalopathy, Meningitis
Classification by specialty
| Medicine in general | Neurology | Infectious disease |
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of encephalopathy after antiviral drug administration based on the JADER database and pharmacy case data
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 120 | 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 sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Nemoto |
Organization
Aisei Pharmacy Co., Ltd.
Division name
Kanagawa Branch
Zip code
100-0005
Address
Marunouchi Mitsui Building, 2-2-2 Marunouchi, Chiyoda-ku, Tokyo
TEL
03-3240-0222
sentaminami@aisei.co.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Nemoto |
Organization
Aisei Pharmacy Co., Ltd.
Division name
Kanagawa Branch
Zip code
100-0005
Address
Marunouchi Mitsui Building, 2-2-2 Marunouchi, Chiyoda-ku, Tokyo
TEL
03-3240-0222
Homepage URL
sentaminami@aisei.co.jp
Sponsor or person
Institute
Aisei Pharmacy Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Aisei Pharmacy Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aisei Pharmacy Ethics Review Committee
Address
Marunouchi Mitsui Building, 2-2-2 Marunouchi, Chiyoda-ku, Tokyo
Tel
03-3240-0222
sentaminami@aisei.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
1153
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Fill in the tentative dates according to the input format of the UMIN registration format. In this study, the extracted data will be analyzed backward.
Management information
Registered date
| 2025 | Year | 07 | Month | 05 | Day |
Last modified on
| 2025 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066732
