Evaluating criteria for reversing liver fibrosis in patients with NASH

Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis

This study is trying to find better ways to see if liver damage can improve in people with NASH and fatty liver disease by looking at both medical data and simpler tests.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Municipal Administration of Hospitals (Government)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06707129 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients diagnosed with non-alcoholic fatty liver disease (NAFLD) who have non-alcoholic steatohepatitis (NASH) and fibrosis stages F2-4 confirmed by liver biopsy. It aims to collect clinical and pathological data to establish a new pathological evaluation system for assessing fibrosis reversal in NASH. Additionally, the study seeks to identify non-invasive indicators for monitoring this reversal process. By analyzing these data, the researchers hope to refine the criteria for evaluating liver fibrosis in affected patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with confirmed NASH and fibrosis stages F2-4.

Not a fit: Patients with other chronic liver diseases, active infections, or those deemed unsuitable by the investigator may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved methods for assessing and potentially reversing liver fibrosis in patients with NASH.

How similar studies have performed: While there have been studies on NASH and fibrosis, this specific approach to establishing a new evaluation system is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Aged between 18 and 70 years at the time of liver biopsy;
* Gender is not limited;
* Hepatic perforation suggested that NASH complicated with fibrosis stage F2-4;
* Signed written informed consent.

Exclusion Criteria:

* Combined HCV infection, HIV infection, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease Disease, drug-induced liver injury and other chronic liver diseases;
* Women during pregnancy;
* There are the following conditions before liver perforation: HCC or possible HCC (imaging suggests malignant liver occupation); decompensation of cirrhosis (ascites, hepatic encephalopathy, gastrointestinal bleeding, hepatorenal syndrome, etc.); Patients with other malignant tumors; Recipients of liver transplantation;
* Patients considered by the investigator to be unsuitable for this study.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Ditan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Minghui Li

Conditions Non-alcoholic Fatty Liver Disease; non-alcoholic fatty liver disease; nonalcoholic steatohepatitis; liver biopsy; Fibrosis reversal; histopathology