Precise Evaluation Criteria for Histological Regression of NASH Fibrosis

Capital Medical University

Status: Not yet enrolling

Conditions: NASH; Liver Fibrosis

Treatments: Other: lifestyle intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06364462

ZLRK202301

Details and patient eligibility

About

It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-70 years of age.
• Liver biopsy-proven NASH fibrosis with stage F2-4.
• Signature of written informed consent.

Exclusion criteria

• Patients with other liver diseases, including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, genetic metabolic liver disease, drug-induced liver diseases, and infected with HIV.
• Pregnant women.
• Patients have the following conditions before liver biopsy:

Hepatocellular carcinoma or suspected liver cancer; Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatorenal syndrome; Other malignancy; Undergone liver transplantation surgery;

• Patients with any other reasons not suitable for the study.

Trial design

220 participants in 1 patient group

Observational group of NASH-related liver fibrosis

Treatment:

Other: lifestyle intervention