Precise Evaluation Criteria for Histological Regression of NASH Fibrosis

Not yet recruiting

• Conditions: NASH; Liver Fibrosis
• Interventions: Other: lifestyle intervention

• Registration Number: NCT06364462
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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, ...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29
• Study Start: 2024-06-15
• Primary Completion: 2027-03-09
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational group of NASH-related liver fibrosis	lifestyle intervention	-

Primary Outcome Measures

Name	Time	Method
Regression of NASH fibrosis	1-3 years	Regression of NASH fibrosis based on liver biopsy

Secondary Outcome Measures

Name	Time	Method
Dynamic changes of Magnetic Resonance Elastography (MRE)	3 years	Dynamic changes of MRE, higher scores mean a worse outcome.
Incidence of extrahepatic related events	3 years	Incidence of cardiovascular and cerebrovascular events, extrahepatic malignancies, metabolic diseases
Dynamic changes of liver stiffness measurements (LSM)	3 years	Dynamic changes of liver stiffness measurements (LSM)
Dynamic changes of metabolic markers	3 years	Dynamic changes of serum lipid level
Dynamic changes of non-invasive liver fibrosis models	3 years	Dynamic changes of FibroScan-aspartate aminotransferase score (FAST), higher scores mean a worse outcome.
Incidence of liver-related events	3 years	Incidence of ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatocellular carcinoma, liver-related death/liver transplantation
Dynamic changes of Controlled Attenuation Parameter (CAP)	3 years	Dynamic changes of CAP, higher scores mean a worse outcome.
Dynamic changes of Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)	3 years	Dynamic changes of MRI-PDFF, higher scores mean a worse outcome.