Prospective Cohort Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- Prevalence of cirrhosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: Pioglitazone metformin tablets (Drug)
Other drug
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)
干预措施: Other drugs (Drug)
Drug-free
Drug-free
干预措施: Drug-free (Other)
结局指标
主要结局
Prevalence of cirrhosis
时间窗: Through study completion, an average of 96 week.
Prevalence of liver transplantation
时间窗: Through study completion, an average of 96 week.
Controlled attenuation parameter (CAP)
时间窗: Through study completion, an average of 96 week.
Transient elastography
时间窗: Through study completion, an average of 96 week.
Model for end-stage liver disease score
时间窗: 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)
时间窗: Through study completion, an average of 96 week.
Prevalence of decompensated cirrhosis
时间窗: Through study completion, an average of 96 week.
次要结局
未报告次要终点