Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal
Recruiting · NCT06707129 · Observational (researchers observe without assigning treatment) · Lead sponsor: Beijing Municipal Administration of Hospitals
View the official record on ClinicalTrials.gov →Interventions studied
life-style
What this trial is about
Collect confirmed cases of NAFLD patients and enroll them in the study. Select patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy, and collect clinical and pathological data for relevant evaluation and definition. Establish a NASH "fibrosis reversal" pathological evaluation system, based on a new reversal standard, establish non-invasive alternative indicators, and observe indicators.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- Beijing Ditan Hospital, Capital Medical University - Beijing, Beijing Municipality, China