Precise Evaluation Criteria for Histological Regression of NASH Fibrosis

Liver Fibrosis Clinical Trial

Official title:

Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364462
• Other study ID #: ZLRK202301
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2024
• Source: Beijing Friendship Hospital
• Contact: Yameng Sun, M.D.
• Phone: 86-010-63138656
• Email: sunyamenggo[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: April 1, 2027
• Est. primary completion date: March 9, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis
• NASH

Intervention

Other:
• lifestyle intervention
Dietary recommendations should consider energy restriction and exclusion of MAFLD-mediating components (processed food, food and beverages high in added fructose). A Mediterranean type diet is advisable. Both aerobic exercise and resistance training effectively reduce liver fat and should be tailored based on patient preferences to ensure long-term adherence.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regression of NASH fibrosis	Regression of NASH fibrosis based on liver biopsy	1-3 years
Secondary	Dynamic changes of liver stiffness measurements (LSM)	Dynamic changes of liver stiffness measurements (LSM)	3 years
Secondary	Dynamic changes of Controlled Attenuation Parameter (CAP)	Dynamic changes of CAP, higher scores mean a worse outcome.	3 years
Secondary	Dynamic changes of Magnetic Resonance Elastography (MRE)	Dynamic changes of MRE, higher scores mean a worse outcome.	3 years
Secondary	Dynamic changes of Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)	Dynamic changes of MRI-PDFF, higher scores mean a worse outcome.	3 years
Secondary	Dynamic changes of non-invasive liver fibrosis models	Dynamic changes of Aspartate Aminotransferase to Platelet Ratio Index (APRI), , higher scores mean a worse outcome.	3 years
Secondary	Dynamic changes of non-invasive liver fibrosis models	Dynamic changes of Fibrosis-4 Index (FIB-4), higher scores mean a worse outcome.	3 years
Secondary	Dynamic changes of non-invasive liver fibrosis models	Dynamic changes of BARD (BMI, AST/ALT Ratio, Diabetes), higher scores mean a worse outcome.	3 years
Secondary	Dynamic changes of non-invasive liver fibrosis models	Dynamic changes of NAFLD Fibrosis Score (NFS), higher scores mean a worse outcome.	3 years
Secondary	Dynamic changes of non-invasive liver fibrosis models	Dynamic changes of FibroScan-aspartate aminotransferase score (FAST), higher scores mean a worse outcome.	3 years
Secondary	Dynamic changes of metabolic markers	Dynamic changes of Body Mass Index (BMI), higher scores mean a worse outcome.	3 years
Secondary	Dynamic changes of metabolic markers	Dynamic changes of fasting glucose	3 years
Secondary	Dynamic changes of metabolic markers	Dynamic changes of serum lipid level	3 years
Secondary	Incidence of liver-related events	Incidence of ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatocellular carcinoma, liver-related death/liver transplantation	3 years
Secondary	Incidence of extrahepatic related events	Incidence of cardiovascular and cerebrovascular events, extrahepatic malignancies, metabolic diseases	3 years