Investigating the immune response in liver disease
Prospective Studies on the Immunopathogenesis of Fibrosis in Acute and Chronic Liver Diseases
This study is trying to understand how the immune system affects liver inflammation and scarring in people with chronic liver disease compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Regensburg Academic / other |
| Locations | 1 site (Regensburg, Bavaria) |
| Trial ID | NCT04943978 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of the immune system in the development of liver inflammation and fibrosis in patients with chronic liver disease. It will compare the cellular immune responses of patients with various liver conditions, such as autoimmune hepatitis and viral hepatitis, to those of healthy individuals. Blood samples and liver tissue will be collected for immunological analysis, allowing researchers to identify specific immune cell populations that may influence disease progression. The findings could lead to more targeted treatments for liver diseases based on individual immune profiles.
Who should consider this trial
Good fit: Ideal candidates include adults with chronic liver disease, such as viral hepatitis, autoimmune hepatitis, or liver fibrosis.
Not a fit: Patients under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of liver disease mechanisms and lead to improved, personalized treatment strategies for patients.
How similar studies have performed: While there have been studies on immune responses in liver disease, this specific approach focusing on a comprehensive immunological analysis in a prospective manner is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with chronic liver disease up to progressive cirrhosis (e.g. ethyltoxic, Viral hepatitis, fatty liver, autoimmune hepatitis, colorectal liver metastases, HCC). Patients with elevated liver values undergoing elective abdominal surgery. As comparison groups patients with acute hepatitis (e.g. viral or autoimmune genesis) and patients without liver disease. Exclusion Criteria: Age under 18
Where this trial is running
Regensburg, Bavaria
- Dept. of Surgery, University Hospital Regensburg — Regensburg, Bavaria, Germany (Recruiting)
Study contacts
- Study coordinator: Jens M. Werner, MD
- Email: jens.werner@ukr.de
- Phone: +49941944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.