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Exploratory study of biomarkers for liver fibrosis assessment using non-invasive samples

Exploratory study of biomarkers for liver fibrosis assessment using non-invasive samples - Exploratory study of biomarkers for liver fibrosis assessment using non-invasive samples

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050863
Enrollment
50
Registered
2023-04-17
Start date
2023-05-22
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

Nonalcoholic Fatty Liver Disease

Interventions

To apply a tape to collect sebum on the site of collection (forehead, neck, precordium) for long times.

Sponsors

Chugai Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Common items: The contents of the present research have been sufficiently explained, and their written voluntary consent has been obtained. - >= 18 to =< 70 years For healthy adult volunteers: - without fatty liver - Not to have any disease requiring outpatient visits and am healthy. - Normal renal function For patients with nonalcoholic fatty liver disease: - diagnosed with hepatic steatosis or steatohepatitis in the past - The subject has fatty deposits in the liver confirmed by abdominal ultrasound performed within 6 months prior to the day of sebum collection.

Exclusion criteria

Exclusion criteria: Common items: - Ethanol hypersensitivity - Persons who have experienced skin irritation by adhesive tapes - Alcohol consumption >= 30 g/day (males) or >= 20 g/day (females). - Taking supplements such as vitamin and Minerals within 1 week of the day of sample collection (However, drugs including vitamins and minerals that are continuously used as therapeutic drugs for diseases are excluded.) - Prior surgery of the pancreatic and gallbladder system - Researchers involved in this research - the doctor judges it difficult for you to participate For healthy volunteers: - Hepatobiliary disease and medical history - Abdominal echo shows fatty liver For patients with nonalcoholic fatty liver disease: - Moderate or severe renal impairment (eGFR < 60 mL/min/1.73 m^2) - other hepatobiliary disorders are suspected; alcoholic liver disease, autoimmune liver disease, cholangitis, Alpha-1 antitrypsin deficiency, such as Wilson disease, Drug-induced liver injury, viral liver diseases such as HBV/HCV, cirrhosis, liver cancer, previous intravenous drug administration within 1 month before sample collection, Thyroid and adrenal disorders

Design outcomes

Primary

MeasureTime frame
Selection of biomarker candidates related with liver fibrosis by metabolome analysis in sebum components

Countries

Japan

Contacts

Public ContactChugai Pharmaceutical Co., Ltd. Clinical trials information

Chugai Pharmaceutical Co., Ltd. Clinical Strategy and Resource Management Dept.

clinical-trials@chugai-pharm.co.jp0120189706

Outcome results

None listed

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