Precise Evaluation Criteria for Histological Regression of NASH Fibrosis

NCT06364462 | Not Yet Recruiting DMC

• 1 other identifier: ZLRK202301
• Study Type: observational
• Target: 220
• Locations: 0 countries
• Sites: N/A

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

Conditions

NASH; Liver Fibrosis

Keywords

NASH; Liver fibrosis

Outcome Measures

Primary Outcomes (1)

• Regression of NASH fibrosis

  Regression of NASH fibrosis based on liver biopsy

  1-3 years

Secondary Outcomes (14)

• Dynamic changes of liver stiffness measurements (LSM)

  3 years

• Dynamic changes of Controlled Attenuation Parameter (CAP)

  3 years

• Dynamic changes of Magnetic Resonance Elastography (MRE)

  3 years

• Dynamic changes of Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)

  3 years

• Dynamic changes of non-invasive liver fibrosis models

  3 years

Study Arms (1)

Observational group of NASH-related liver fibrosis

Other: lifestyle intervention

Interventions

lifestyle intervention OTHER

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.

Observational group of NASH-related liver fibrosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yameng Sun, M.D.

CONTACT

86-010-63138656; sunyamenggo@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: April 15, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): March 9, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 29, 2024

Record last verified: 2024-05