Evaluating criteria for reversing liver fibrosis in patients with NASH
Official title: Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis
Run by Beijing Municipal Administration of Hospitals · NCT06707129 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Beijing Municipal Administration of Hospitals Government |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | November 27, 2024 |
| Trial ID | NCT06707129 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 70 with confirmed NASH and fibrosis stages F2-4.
✕Probably not a fit
Patients with other chronic liver diseases, active infections, or those deemed unsuitable by the investigator may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Minghui Li
- Email: wuhm2000@sina.com
- Phone: +8613693259096
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.