Overview

Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

Status:
Not yet recruiting
Trial end date:
2026-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Affiliated Hospital of Hangzhou Normal University
Treatments:
Metformin
Pioglitazone
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.