Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

Study Overview
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Brief Summary
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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.

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

Conditions
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Metabolic Dysfunction-associated Fatty Liver Disease, Cirrhosis

Intervention / Treatment
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* Drug: Pioglitazone metformin tablets
* Drug: Other drugs
* Other: Drug-free


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pioglitazone metformin tablets<br>Pioglitazone metformin tablets 15mg/500mg (To control the fasting blood glucose below 7.0mmol/l, adjust the dose and dosage according to the blood glucose) | Drug: Pioglitazone metformin tablets<br>* Drug intervention for 24 weeks and follow-up for another 72 weeks (fasting blood glucose was controlled below 7.0mmol/l throughout the study)<br>|
| Active Comparator: Other drug<br>Chinese patent medicine or Hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin and GLP1 ((To control the fasting blood glucose below 7.0mmol/l) | Drug: Other drugs<br>* Chinese patent medicine or hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin, GLP1<br>|
| Other: Drug-free<br>Drug-free | Other: Drug-free<br>* Drug-free<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Controlled attenuation parameter (CAP) |  | Through study completion, an average of 96 week. | 
| Transient elastography |  | Through study completion, an average of 96 week. | 
| Model for end-stage liver disease score | Model for end-stage liver disease score ranges from 6 to 40 score (>40 calculated as 40 scores)，higher scores mean a worse outcome | Through study completion, an average of 96 week. | 
| Portalvein pressure gradient(HVPG) |  | Through study completion, an average of 96 week. | 
| Prevalence of cirrhosis |  | Through study completion, an average of 96 week. | 
| Prevalence of liver transplantation |  | Through study completion, an average of 96 week. | 
| Prevalence of decompensated cirrhosis |  | Through study completion, an average of 96 week. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Strategies, Multicenter Real-World Study