Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

Recruiting now

Conditions studied: Non-alcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID

NCT06707129

Run by

Beijing Municipal Administration of Hospitals

People needed

50

Starts

2024-08-01

Expected to finish

2027-08-31

Last updated by the study team

2024-11-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

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

Full record on ClinicalTrials.gov

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