An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
Observational · No treatment assigned · 1 site · University of Copenhagen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Chronic Liver Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Adult patients/healthy control participants (age 18 or above) who can give their informed consent
- Suspected liver disease:
- non-alcoholic steatohepatitis
- alcoholic steatohepatitis
- autoimmune hepatitis
- primary biliary cholangitis
Plus 7 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 335 participants are expected to take part.
- Start date: 2020-08-24.
- Main results expected around 2036-08 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Denmark.
Main thing being measured
- Identification and validation of a diagnostic classifier enabling discrimination of chronic liver diseases. (10 years)
In the researchers’ words
Hepatic steatosis may cause inflammation and fibrosis within the liver potentially leading to end-stage liver disease cirrhosis, liver failure and death. The condition is associated with several other chronic liver diseases like autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, hereditary hemochromatosis and alpha-1-antitrypsin deficiency and may also develop secondary to other…
Words you might see
- Cirrhosis: advanced scarring of the liver.
- Biopsy / histology: a small tissue sample examined under a microscope.
- PBC: primary biliary cholangitis, a different chronic bile-duct disease.
- Autoimmune hepatitis: a liver disease where the immune system attacks the liver.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Chronic Liver Disease |
| Lead sponsor | University of Copenhagen |
| Collaborators | Hvidovre University Hospital |
| Enrollment | 335 (estimated) |
| Start date | 2020-08-24 |
| Primary completion (est.) | 2036-08 |
| First posted | 2022-04-19 |
| Last updated | 2022-04-19 |
| Official title | Fatty Liver Library (FALL): a Prospective Cohort Study Evaluating the Characteristics of Chronic Liver Diseases Associated With Hepatic Steatosis |
| ClinicalTrials.gov ID | NCT05335603 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * Adult patients/healthy control participants (age 18 or above) who can give their informed consent * Suspected liver disease: * non-alcoholic steatohepatitis * alcoholic steatohepatitis * autoimmune hepatitis * primary biliary cholangitis * primary sclerosing cholangitis * inflammatory bowel disease * polycystic ovary syndrome * hereditary haemochromatosis * chronic pancreatitis * cystic fibrosis * alpha-1 antitrypsin deficiency Exclusion Criteria: Patients with: * malignant diseases * viral hepatitis * human immunodeficiency virus * contraindications to liver biopsy
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | Denmark | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.