Precise Evaluation Criteria for Histological Regression of NASH Fibrosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorBeijing Friendship Hospital
About this trial
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
Qualifiers
18-70 years of age.
Liver biopsy-proven NASH fibrosis with stage F2-4.
Signature of written informed consent.
Disqualifiers
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 with any other reasons not suitable for the study.
Trial design
Treatments tested in this trial
- lifestyle intervention
Treatment groups
220 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov