Clinical trial NCT06364462: Precise Evaluation Criteria for Histological Regression of NASH Fibrosis
Official title: Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: NASH
Liver Fibrosis
Keywords: NASH
Liver fibrosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NASH patients with fibrosis stage F2-4 diagnosed with liver biopsy

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Regression of NASH fibrosis
timeFrame: 1-3 years
Secondary outcomes:
measure: Dynamic changes of liver stiffness measurements (LSM)
timeFrame: 3 years
measure: Dynamic changes of Controlled Attenuation Parameter (CAP)
timeFrame: 3 years
measure: Dynamic changes of Magnetic Resonance Elastography (MRE)
timeFrame: 3 years
measure: Dynamic changes of Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)
timeFrame: 3 years
measure: Dynamic changes of non-invasive liver fibrosis models
timeFrame: 3 years
measure: Dynamic changes of non-invasive liver fibrosis models
timeFrame: 3 years
measure: Dynamic changes of non-invasive liver fibrosis models
timeFrame: 3 years
measure: Dynamic changes of non-invasive liver fibrosis models
timeFrame: 3 years
measure: Dynamic changes of non-invasive liver fibrosis models
timeFrame: 3 years
measure: Dynamic changes of metabolic markers
timeFrame: 3 years
measure: Dynamic changes of metabolic markers
timeFrame: 3 years
measure: Dynamic changes of metabolic markers
timeFrame: 3 years
measure: Incidence of liver-related events
timeFrame: 3 years
measure: Incidence of extrahepatic related events
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Friendship Hospital
name: Jidong Jia, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing 302 Hospital
name: Jingmin Zhao, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing You-an Hospital, Capital Medical University
name: Jing Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Ditan Hospital
name: Minghui Li
role: PRINCIPAL_INVESTIGATOR
References: