Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

Not Applicable

Not yet recruiting

• Conditions: Metabolic Dysfunction-associated Fatty Liver Disease; Cirrhosis
• Interventions: Drug: Pioglitazone metformin tablets; Drug: Other drugs; Other: Drug-free

• Registration Number: NCT06135584
• Lead Sponsor: The Affiliated Hospital of Hangzhou Normal University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-05
• Study First Submitted QC: 2023-11-15
• Last Update Submitted: 2023-11-15
• Study Start: 2023-11-18
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pioglitazone metformin tablets	Pioglitazone metformin tablets	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)
Other drug	Other drugs	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-free	Drug-free	Drug-free

Primary Outcome Measures

Name	Time	Method
Prevalence of cirrhosis	Through study completion, an average of 96 week.
Prevalence of liver transplantation	Through study completion, an average of 96 week.
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	Through study completion, an average of 96 week.	Model for end-stage liver disease score ranges from 6 to 40 score (\>40 calculated as 40 scores)，higher scores mean a worse outcome
Portalvein pressure gradient(HVPG)	Through study completion, an average of 96 week.
Prevalence of decompensated cirrhosis	Through study completion, an average of 96 week.