NCT06364462尚未招募不适用
Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 主要终点
- Regression of NASH fibrosis
研究概览
简要总结
It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18-70 years of age.
- •Liver biopsy-proven NASH fibrosis with stage F2-
- •Signature of written informed consent.
排除标准
- •Patients with other liver diseases, including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, genetic metabolic liver disease, drug-induced liver diseases, and infected with HIV.
- •Pregnant women.
- •Patients have the following conditions before liver biopsy:
- •Hepatocellular carcinoma or suspected liver cancer; Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatorenal syndrome; Other malignancy; Undergone liver transplantation surgery;
- •Patients with any other reasons not suitable for the study.
结局指标
主要结局
Regression of NASH fibrosis
时间窗: 1-3 years
Regression of NASH fibrosis based on liver biopsy
次要结局
- Dynamic changes of Magnetic Resonance Elastography (MRE)(3 years)
- Incidence of extrahepatic related events(3 years)
- Dynamic changes of liver stiffness measurements (LSM)(3 years)
- Dynamic changes of metabolic markers(3 years)
- Dynamic changes of non-invasive liver fibrosis models(3 years)
- Incidence of liver-related events(3 years)
- Dynamic changes of Controlled Attenuation Parameter (CAP)(3 years)
- Dynamic changes of Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)(3 years)
研究者
Jidong Jia
Principal Investigator
Beijing Friendship Hospital
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