This is a multi-center, prospective, observational registry platform study aimed at describing the clinical characteristics and diagnosis and treatment patterns of Chinese patients with nonalcoholic steatohepatitis (NASH) with fibrosis.
Non-alcoholic fatty liver disease (NAFLD) is a metabolic stress-induced liver injury closely related to insulin resistance and genetic susceptibility, and its disease spectrum includes non-alcoholic fatty liver (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis and hepatocellular carcinoma (HCC). NASH is a severe form of NAFLD, defined as more than 5% hepatocellular steatosis combined with intralobular inflammation and hepatocellular ballooning degeneration. By conducting research on the NASH patient registry platform and collecting real-world data on the clinical characteristics and diagnosis and treatment patterns of NASH patients, including demographics, clinical characteristics, treatment, outcomes, healthcare utilization, lifestyle, and genotype, on the one hand, it can provide evidence of scientific value for clinical practice and formulate diagnosis and treatment guidelines, and on the other hand, it can promote the clinical development of NASH drugs in China. This is a multi-center, prospective, observational registry platform study. Patient recruitment is tentatively scheduled from December 2023 to December 2024. NASH with fibrosis that meets the inclusion criteria but does not meet the exclusion criteria will be consecutively enrolled in the selected center. The estimated number of patients is 2,500, which will be adjusted according to the progress of research. Among these subjects, information on two genes, PNPLA3 and HSD17B13, will be collected from approximately 500 NASH patients with fibrosis stage F2 or higher.
Study Type
OBSERVATIONAL
Enrollment
1,122
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Chengdu, China
1.Patient demography
Gender (male, female) ,age (years),time since pathological diagnosis of NASH (months), proportion of comorbidities
Time frame: Baseline
2.The proportion of 4 NASH treatment modalities at baseline and follow-up
NASH treatment modalities include:Drug treatment,Non-drug treatment,Combined treatment and No treatment received
Time frame: up to 3-year follow-up
3.NASH Knowledge, Belief and Practice Questionnaire responses at baseline and follow-up
Describe the responses of patients to the NASH Knowledge, Belief and Practice Questionnaire at baseline and follow-up periods. The questionnaire includes NASH patients' knowledge, attitude, and behavior towards NASH disease, NASH-related medical service needs, expectations, satisfaction, and does not involve the evaluation of scores.
Time frame: up to 3-year follow-up
1. The correlation between non-invasive diagnostic methods and pathological results of liver biopsy in NASH patients
Non-invasive diagnostic methods for NASH (serological or imaging indicators during baseline and follow-up periods, including FIB-4, APRI, NAFLD fibrosis score (NFS), BARD, fatty liver index (FLI), Hepatic steatosis index (HSI), VCTE, MRE, MRI-PDFF, FAST, etc.); Liver biopsy pathology: Liver biopsy pathology results during baseline and follow-up periods, including NASH pathological diagnosis, NAFLD activity score (NAS) and pathological fibrosis grade.
Time frame: up to 3-year follow-up
2.The annual frequency of liver related visits
Liver-related visits include liver related outpatient visits, emergency department visits, and hospitalizations
Time frame: up to 3-year follow-up
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Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Hangzhou, China
Research Site
Inner Mongolia, China
Research Site
Nanchang, China
Research Site
Qingdao, China
Research Site
Shanghai, China
...and 6 more locations
3.Total liver-related cost
Total liver-related cost includes total liver-related outpatient and hospitalization costs
Time frame: up to 3-year follow-up