Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Hangzhou Normal University

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Pioglitazone metformin tablets
  • Other drugs
  • Drug-free

Treatment groups

1,000 Participants
are divided into 3 treatment groups

Locations

This trial has no locations