Clinical trial NCT06135584: Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies
Official title: Prospective Cohort Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Dysfunction-associated Fatty Liver Disease
Cirrhosis
Keywords: Treatment Strategies
Multicenter Real-World Study
Lead sponsor: The Affiliated Hospital of Hangzhou Normal University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To establish a prospective, multicenter, biopsie-confirmed clinical cohort of MAFLD-related cirrhosis (F3-F4) in China, and analyze the clinical, histopathological features and natural outcomes of MAFLD-associated liver fibrosis/cirrhosis in China. And than to conducted a real-world study of different strategies of Chinese characteristics for the prevention and treatment of MAFLD-related cirrhosis to evaluate the efficacy and safety of the strategies.


Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years old, gender and ethnicity are not limited;
2. Meet the diagnostic criteria for MAFLD;
3. F0-F4 stage of liver fibrosis confirmed by liver biopsy within 24 weeks;
4. Be willing to sign informed consent.

Exclusion Criteria:

1. Cirrhosis due to any chronic liver disease other than MAFLD (including but not limited to alcohol or drug abuse, medications, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency);
2. Any clinical evidence or history of peritonitis, varicose bleeding, or spontaneous encephalopathy;
3. According to the investigators' assessment, a history of heavy drinking for more than 3 months continuously within the previous year was selected. (Note: Heavy drinking was defined as more than 20 g per day on average for female subjects and more than 30 g per day for male subjects).
4. Use of NAFLD-related medication history (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, larger than hormone replacement doses of estrogen, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks within the year prior to screening.

Primary outcomes:
measure: Controlled attenuation parameter (CAP)
timeFrame: Through study completion, an average of 96 week.
measure: Transient elastography
timeFrame: Through study completion, an average of 96 week.
measure: Model for end-stage liver disease score
timeFrame: Through study completion, an average of 96 week.
measure: Portalvein pressure gradient(HVPG)
timeFrame: Through study completion, an average of 96 week.
measure: Prevalence of cirrhosis
timeFrame: Through study completion, an average of 96 week.
measure: Prevalence of liver transplantation
timeFrame: Through study completion, an average of 96 week.
measure: Prevalence of decompensated cirrhosis
timeFrame: Through study completion, an average of 96 week.
Secondary outcomes:
Other outcomes:
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Study officials:
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