Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pioglitazone metformin tablets, Other drugs, Drug-free.
- Who it may be relevant to
- Registry conditions: Metabolic Dysfunction-associated Fatty Liver Disease, Cirrhosis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Cohort Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies
Overview
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.
Interventions
- Drug Pioglitazone metformin tablets
Drug intervention for 24 weeks and follow-up for another 72 weeks (fasting blood glucose was controlled below 7.0mmol/l throughout the study) - Drug Other drugs
Chinese patent medicine or hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin, GLP1 - Other Drug-free
Drug-free
Primary outcome measures
- Controlled attenuation parameter (CAP) [Time frame: Through study completion, an average of 96 week.]
- Transient elastography [Time frame: Through study completion, an average of 96 week.]
- Model for end-stage liver disease score [Time frame: Through study completion, an average of 96 week.]
- Portalvein pressure gradient(HVPG) [Time frame: Through study completion, an average of 96 week.]
- Prevalence of cirrhosis [Time frame: Through study completion, an average of 96 week.]
- Prevalence of liver transplantation [Time frame: Through study completion, an average of 96 week.]
- Prevalence of decompensated cirrhosis [Time frame: Through study completion, an average of 96 week.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06135584 · SMART