Status:
NOT_YET_RECRUITING
Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies
Lead Sponsor:
The Affiliated Hospital of Hangzhou Normal University
Conditions:
Metabolic Dysfunction-associated Fatty Liver Disease
Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
NA
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 MAF...
Eligibility Criteria
Inclusion
- Age 18-75 years old, gender and ethnicity are not limited;
- Meet the diagnostic criteria for MAFLD;
- F0-F4 stage of liver fibrosis confirmed by liver biopsy within 24 weeks;
- Be willing to sign informed consent.
Exclusion
- 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);
- Any clinical evidence or history of peritonitis, varicose bleeding, or spontaneous encephalopathy;
- 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).
- 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.
Key Trial Info
Start Date :
November 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06135584
Start Date
November 18 2023
End Date
December 31 2026
Last Update
November 18 2023
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