Precise Evaluation Criteria for Histological Regression of NASH Fibrosis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Fibrosis; NASH
• Intervention / Treatment: Other: lifestyle intervention

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Yameng Sun, M.D.; Phone Number: 86-010-63138656; Email: sunyamenggo@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

NASH patients with fibrosis stage F2-4 diagnosed with liver biopsy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational group of NASH-related liver fibrosis	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regression of NASH fibrosis	Regression of NASH fibrosis based on liver biopsy	1-3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic changes of liver stiffness measurements (LSM)	Dynamic changes of liver stiffness measurements (LSM)	3 years
Dynamic changes of CAP	Dynamic changes of CAP	3 years
Dynamic changes of MRE	Dynamic changes of MRE	3 years
Dynamic changes of MRI-PDFF	Dynamic changes of MRI-PDFF	3 years
Dynamic changes of non-invasive liver fibrosis models	Dynamic changes of APRI	3 years
Dynamic changes of non-invasive liver fibrosis models	Dynamic changes of FIB-4	3 years
Dynamic changes of non-invasive liver fibrosis models	Dynamic changes of BARD	3 years
Dynamic changes of non-invasive liver fibrosis models	Dynamic changes of NFS	3 years
Dynamic changes of non-invasive liver fibrosis models	Dynamic changes of FAST	3 years
Dynamic changes of metabolic markers	Dynamic changes of BMI	3 years
Dynamic changes of metabolic markers	Dynamic changes of fasting glucose	3 years
Dynamic changes of metabolic markers	Dynamic changes of serum lipid level	3 years
Incidence of liver-related events	Incidence of ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatocellular carcinoma, liver-related death/liver transplantation	3 years
Incidence of extrahepatic related events	Incidence of cardiovascular and cerebrovascular events, extrahepatic malignancies, metabolic diseases	3 years

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: Jidong Jia, Professor, Beijing Friendship Hospital; Principal Investigator: Jingmin Zhao, Professor, Beijing 302 Hospital; Principal Investigator: Jing Zhang, Beijing You-an Hospital, Capital Medical University; Principal Investigator: Minghui Li, Beijing Ditan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): March 9, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: NASH; Liver fibrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ZLRK202301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No