Evaluation of Antiviral Indications and Therapeutic Effect by Liver Biopsy Combined With Clinical Trial Parameters on Chronic HBV Infection With Different Transaminase Levels
试验速览
- 阶段
- 不适用
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Virological response in patients with different ALT levels
研究概览
简要总结
It remains unknown whether antiviral therapy is beneficial for chronic hepatitis B (CHB) with normal or mild ALT.The investigators aim to evaluate the antiviral indications combining liver biopsy and clinical parameters,and further clarify the response indexes of clinical results such as virological, serological, biochemical and histological responses from a retrospective observational cohort study on antiviral therapy in HBeAg positive and negative patients with different ALT levels,especially when ALT lower 2 times upper limit of normal (ULN).
详细描述
It is estimated that 400 million people worldwide are chronically infected with hepatitis B virus (HBV).Chronic hepatitis B (CHB) often leads to serious health conditions including decompensated liver cirrhosis and hepatocellular carcinoma (HCC). Therefore, the goal of chronic hepatitis B (CHB) therapy is to achieve sustained suppression of HBV replication and remission of liver disease.Clinical CHB management guidelines suggest recommend threshold for antiviral therapy when ALT was more than 2 times ULN.No antiviral drugs are recommended for patients with normal ALT or mildly elevated ALT unless they exhibit symptoms of advanced fibrosis or liver cirrhosis.But chronic HBV infections with normal or mild ALT levels may develop latently into CHB,even cirrhosis and hepatocellular carcinoma (HCC).The ALT level is easily influenced by many factors.Antiviral therapy may still be needed for some HBV patients with normal or mildly abnormal ALT levels. Therefore, the investigator's purpose is to evaluate of antiviral indications and therapeutic effect by liver biopsy and clinical trial parameters on chronic HBV infection with different ALT levels,especially when ALT lower 2 times upper limit of normal (ULN).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •All of below
- •Patients with chronic HBV infection,defined as those in whom presence of serum hepatitis B surface(HBsAg) for more than 6 months;
- •All patients had underwent a liver biopsy;
- •All patients signed the informed consent before liver biopsy;
- •No history use of interferon or Nucleoside analogue treatment.
排除标准
- •Any of below
- •Co-infection with hepatitis A virus(HAV),hepatitis C virus(HCV),hepatitis D virus(HDV) hepatitis E virus(HEV) and/or human immunodeficiency virus(HIV);
- •Decompensated cirrhosis;
- •History of hepatocellular carcinoma(HCC);
- •History of liver transplantation;
- •Patient with a history of antiviral treatment;
- •Patient has medical condition that requires concurrent use of systemic prednisolone or other immunosuppressive agent (including chemotherapeutic agent)
- •Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis,alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.)
- •Patient who interrupted antiviral therapy;
- •Patient with incomplete data;
- •Follow up less than 1 year.
结局指标
主要结局
Virological response in patients with different ALT levels
时间窗: at 1 year
Serum HBV DNA will be summarized and compared between different groups at baseline and follow-up endpoint
次要结局
- Changes in serum HBsAg, HBeAg ,HBeAb ,HBcAb levels between treated and untreated groups(at baseline and 1 year)
- Proportion of patients with normal alanine aminotransferase(ALT) between treated and untreated groups(at baseline and 1 year)
- Liver stiffness measurement(LSM) changes between treated and untreated groups(at baseline and 1 year)
- Proportion of patients with HBsAg loss or seroconversion(at 1 year)
- (5) Predictive values of HBV DNA,HBsAg and LSM for the antiviral indications of chronic HBV infection with different ALT levels(at baseline)