NCT05335603 An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
| NCT ID | NCT05335603 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Copenhagen |
| Condition | Chronic Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 335 participants |
| Start Date | 2020-08-24 |
| Primary Completion | 2036-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 335 participants in total. It began in 2020-08-24 with a primary completion date of 2036-08.
⚠ 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
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 diseases like inflammatory bowel disease and chronic pancreatitis. Diagnosing chronic liver diseases can be challenging and treatment may be limited. In-depth phenotyping at a tissue level may generate insight into the underlying pathophysiology of diseases and furthermore identify common as well as specific diagnostic biomarkers and future treatment targets of the diseases. We therefore undertake a study that evaluates patients with chronic liver diseases associated with hepatic steatosis.
Eligibility Criteria
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
Contact & Investigator
Lise L Gluud, Professor
PRINCIPAL INVESTIGATOR
Hvidovre University Hospital
Frequently Asked Questions
Who can join the NCT05335603 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05335603 currently recruiting?
Yes, NCT05335603 is actively recruiting participants. Contact the research team at anne-sofie.houlberg.jensen@regionh.dk for enrollment information.
Where is the NCT05335603 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT05335603 clinical trial?
NCT05335603 is sponsored by University of Copenhagen. The principal investigator is Lise L Gluud, Professor at Hvidovre University Hospital. The trial plans to enroll 335 participants.