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New treatment option for Liver Diseases, Alcoholic
Official title Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
ClinicalTrials.gov ID: NCT03308916
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 75
You may be able to join if
- Patients are eligible for screening if the following 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...
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- Patients are eligible for screening if the following 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Odense, Denmark
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.