Fact CheckerSign in

NCT06135584Not yet recruiting

Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

Prospective Cohort Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

Source: ClinicalTrials.gov · Last updated 18 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
5 Nov 2023
Start date
18 Nov 2023
Primary completion date
31 Dec 2026
Lead sponsor
The Affiliated Hospital of Hangzhou Normal University
NCT number
NCT06135584

What you commit to

  • Study type: Interventional
  • Planned participants: 1000
  • From 18 Nov 2023 to the primary completion date, 31 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.