NCT03308916 Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
| NCT ID | NCT03308916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maja Thiele |
| Condition | Liver Diseases, Alcoholic |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,500 participants |
| Start Date | 2017-10-06 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,500 participants in total. It began in 2017-10-06 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prospective screening study at Odense University Hospital to assess the effect of transient elastography and other serum and imaging markers of liver fibrosis to detect advanced fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver disease, alcoholic fatty liver disease, with a control group of participants recruited from the general population.
Eligibility Criteria
INCLUSION CRITERIA Patients are eligible for screening if the following inclusion criteria are fulfilled: * Age 30-75 years (except the general population, which should be aged 40-75) * Informed consent to study investigations * Ability to read and write Danish AND (only at-risk patients) * Prior or current alcohol overuse, defined as an average intake of ≥24 grams/day (14 units/week) for women and ≥36 grams/day (21 units/week) for men, for at least 5 years; OR * Presence of the metabolic syndrome defined by central obesity plus any two of the following four metabolic risk factors: (a) raised triglycerides, (b) reduced HDL cholesterol, (c) raised blood pressure and (d) raised fasting plasma glucose;\[38\] OR * Type 2 diabetes mellitus defined by either fasting plasma glucose ≥7 mmol/L, HbA1c ≥48 mmol/mol, a random plasma glucose ≥11.1 mmol/L in the presence of classic diabetes or an oral glucose tolerance test with fasting plasma glucose ≥7.0 mmol/L and/or 2 hour plasma glucose ≥11.1 mmol/L. EXCLUSION CRITERIA We will exclude patients from screening in case of: * Evidence of decompensated liver disease, defined by clinically obvious ascites, overt hepatic encephalopathy, jaundice or large esophageal varices with/without variceal bleeding. * Known concurrent liver disease other than ALD and NAFLD. * Cancer or other debilitating disease with an expected survival of less than 12 months. * Inability to comply with the study protocol. In screened patients with liver stiffness ≥8 kPa we will abstain from a liver biopsy in case of: * Contraindications for a percutaneous liver biopsy * Severe alcoholic hepatitis or other hepatic inflammation evidenced by transaminase elevation of more than three times the upper limit of normal. * Hepatic congestion or bile duct dilation evidenced by ultrasound. * Decrease of TE below 6.0 kPa from screening to time of planned liver biopsy.
Contact & Investigator
Maja Thiele, MD, PhD, Professor
PRINCIPAL INVESTIGATOR
Department of Gastroenterology and Hepatology, Odense University Hospital
Frequently Asked Questions
Who can join the NCT03308916 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 75 Years, studying Liver Diseases, Alcoholic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03308916 currently recruiting?
Yes, NCT03308916 is actively recruiting participants. Contact the research team at maja.thiele@rsyd.dk for enrollment information.
Where is the NCT03308916 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT03308916 clinical trial?
NCT03308916 is sponsored by Maja Thiele. The principal investigator is Maja Thiele, MD, PhD, Professor at Department of Gastroenterology and Hepatology, Odense University Hospital. The trial plans to enroll 6,500 participants.