UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061896 |
|---|---|
| Receipt number | R000070823 |
| Scientific Title | Verification of ADH1B and ALDH2 Gene Polymorphisms Affecting Severe Alcoholic Hepatitis: A Multicenter Study |
| Date of disclosure of the study information | 2026/06/13 |
| Last modified on | 2026/06/13 16:11:59 |
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Basic information
Public title
A Multicenter Observational Study on the Relationship between Severe Alcoholic Hepatitis and Alcohol-Metabolizing Gene Polymorphisms (ADH1B and ALDH2)
Acronym
SAH-GENE study
Scientific Title
Verification of ADH1B and ALDH2 Gene Polymorphisms Affecting Severe Alcoholic Hepatitis: A Multicenter Study
Scientific Title:Acronym
SAH-GENE study
Region
| Japan |
Condition
Condition
Severe Alcoholic Hepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Severe alcoholic hepatitis (SAH) is a rare and extremely poor-prognosis condition characterized by acute jaundice, marked inflammatory response, and multi-organ failure, occurring in a small subset of patients with alcoholic hepatitis associated with chronic heavy alcohol consumption. A clinically important issue is that "only a fraction of patients with comparable drinking histories develop severe acute-type disease," which highlights the rarity and heterogeneity of this condition.
In East Asian populations, functional polymorphisms in ADH1B and ALDH2, enzymes involved in ethanol metabolism, are highly prevalent and have been reported to influence various disease phenotypes including flushing response, alcohol dependence, and liver injury (Tadokoro, Nakahara, et al. 2025). However, the extent to which these genetic differences in alcohol metabolic capacity, unique to East Asian populations, determine the onset of SAH has not been investigated. The aim of this study is to identify alcohol metabolism gene polymorphisms specific to SAH.
Basic objectives2
Others
Basic objectives -Others
Verification of the association between gene polymorphisms and the risk of SAH onset and severity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between ADH1B low-activity / ALDH2 active genotype and the onset of severe alcoholic hepatitis (SAH)
Key secondary 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older hospitalized for alcohol-induced liver injury. Written informed consent obtained.
Key exclusion criteria
Patients who do not provide informed consent for genetic testing. Patients whose primary liver disease is attributed to other etiologies such as HBV, HCV, or autoimmune hepatitis.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Tadokoro |
Organization
Kagawa University Faculty of Medicine
Division name
Department of Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
0878985111
tadokoro.tomoko@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Tadokoro |
Organization
Kagawa University Faculty of Medicine
Division name
Department of Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
0878985111
Homepage URL
tadokoro.tomoko@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
none
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
Kagawa University Faculty of Medicine Ethics Committee
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel
0878985111
tadokoro.tomoko@kagawa-u.ac.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
| 2026 | Year | 06 | Month | 13 | 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
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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter observational study without any intervention. Dried saliva samples are collected from patients hospitalized for alcohol-induced liver injury, and ADH1B/ALDH2 genotypes are analyzed by real-time PCR. The association between genotype and the onset/severity of severe alcoholic hepatitis (SAH) will be verified by comparison with GWAS data.
Management information
Registered date
| 2026 | Year | 06 | Month | 13 | Day |
Last modified on
| 2026 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070823
