Tokyo, June 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061896) titled 'A Multicenter Observational Study on the Relationship between Severe Alcoholic Hepatitis and Alcohol-Metabolizing Gene Polymorphisms (ADH1B and ALDH2)' on June 13.

Study Type: Observational

Primary Sponsor: Institute - Kagawa University

Condition: Condition - Severe Alcoholic Hepatitis Classification by malignancy - Others Genomic information - YES

Objective: 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

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 Size - 40

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070823

Disclaimer: Curated by HT Syndication.