A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 16
- 主要终点
- Construct a non-invasive model based on laboratory tests
研究概览
简要总结
The aim of our study is to validate the non-invasive model which was constructed by our previous study for evaluating liver fibrosis or cirrhosis caused by hepatitis B virus in mainland China and to find a therapeutic regimen to reverse liver fibrosis and cirrhosis.
详细描述
450 patients who are infected with hepatitis B virus for at least 6 months will be included in the study. They will be divided into two groups. One group will be treated with Entecavir while another treated with Entecavir and Anluohuaxian Pill. Liver biopsy samples and blood samples from the patients will be used to validate the non-invasive model. Furthermore, the samples will be used to evaluate if Anluohuaxian Pill could reverse liver fibrosis and cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HBsAg positive for at least 6 months
- •Agree to have liver biopsy
- •Male or female aged 18 to 70 years old -
排除标准
- •Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease, nonalcoholic liver disease or other chronic liver disease
- •Platelet count < 80 × 10^9/L
- •Prothrombin activity ≤ 60%
- •Decompensated liver cirrhosis
- •Patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject -
研究组 & 干预措施
Entecavir Group
Patients in this arm will be given Entecavir 0.5 mg a day for 2 years.
干预措施: Entecavir 0.5 mg (Drug)
Entecavir and Anluohuaxian Group
Patients in this arm will be given Entecavir 0.5 mg and Anluohuaxian Pill 12 g a day for 2 years.
干预措施: Entecavir 0.5 mg (Drug)
Entecavir and Anluohuaxian Group
Patients in this arm will be given Entecavir 0.5 mg and Anluohuaxian Pill 12 g a day for 2 years.
干预措施: Anluohuaxian Pill 12g (Drug)
结局指标
主要结局
Construct a non-invasive model based on laboratory tests
时间窗: 26 weeks after liver biopsy
We will measure the following biomarkers: TIMP1，CXCL10，CD25，YKL-40，collagen IV，von Willebrand Factor，TGF-β1，ANGPTL2，MMP-9，IL-2R，PDGF-AA，PDGF-BB，TGF-a，LN，MMP-1, soluble CD163 and CXCL9. To formulate the predictive models for detecting significant fibrosis (Ishak fibrosis score ≥3)， univariate analysis was performed on variables between patients with and without significant fibrosis. The significant variables (p\<0.05) were then subjected to multivariate stepwise logistic regression, using backward approaches, and were combined using the logistic regression function. The diagnostic value of each regression model was assessed using receiver operating characteristics curves.
次要结局
- Compare the difference of fibrosis reverse rates between the two groups(26 weeks after liver biopsy)
研究者
Guiqiang Wang
Principal Investigator
Peking University First Hospital