Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Response rate of 12 weeks of atorvastatin in experimental group and 12 weeks of placebo in control group
研究概览
简要总结
To evaluate whether atorvastatin can improve portal hypertension in patients with chronic hepatitis B related compensated cirrhosis with portal hypertension
详细描述
In order to derive a reliable correlation between statin use and the reduction of portal hypertension, it is necessary to proceed with a clinical study with a high level of evidence, such as a randomized controlled clinical trial study. In addition, previous small randomized controlled trials had a limitation in that patients with various causes of liver cirrhosis were included. In this study, only patients diagnosed with chronic hepatitis B and compensated cirrhosis who are taking antiviral treatment will be included in the study, and in patients whose viral activity are suppressed by taking antiviral treatment, it was investigated whether statin administration had a significant effect in additionally improving portal pressure. We want to prove it through a randomized controlled clinical trial study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between 19 and 69 years of age
- •If HBsAg positivity has been observed for more than 6 months or a clinical history of chronic hepatitis B is confirmed
- •When liver cirrhosis is diagnosed histologically, radiologically, or clinically (if one or more of A-D is applicable) A. When stage F4 fibrosis is confirmed by liver biopsy B. When splenomegaly is observed with morphological changes (surface nodularity and hypertrophy of the caudate lobe) appropriate for liver cirrhosis.
- •C. If the platelet count is less than 100,000/mm3 in two consecutive tests D. When esophageal varices or gastric varices are confirmed by upper gastrointestinal endoscopy
- •If the serum HBV DNA is well controlled to 2000 International Unit (IU)/mL or less while taking antiviral treatment
- •When the splenic elasticity measured by two-dimensional shear wave elastography is greater than 25 kilopascal(kPa)
- •When informed consent is possible
排除标准
- •Hepatitis C or HIV co-infected person
- •Those who continuously drink more than the standard (alcohol intake exceeding 20g per day)
- •In case of decreased liver function with Child Pugh score of 7 or higher
- •History of decompensated cirrhosis: history of ascites, spontaneous bacterial peritonitis, hepatic coma, varicose bleeding, hepatic nephrotic syndrome
- •If there is a history of cancer (except for cases where there is no recurrence for 5 years after treatment due to early solid organ tumors (early gastric cancer, thyroid cancer))
- •If there is a serious comorbidity whose life expectancy is estimated to be less than 3 years
- •In case of chronic kidney disease estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
- •If portal vein thrombosis is diagnosed
- •Previous intrahepatic portal vein shunt intervention or liver transplantation
- •A history of statin administration within the last 2 years
- •In case of side effects from previous statin administration (drug-related hepatotoxicity, muscle toxicity, allergic reaction, etc.)
研究组 & 干预措施
Experimental group
Atorvastatin 10mg once daily for 24 weeks
干预措施: Atorvastatin 10mg (Drug)
Control group
Placebo once daily for 12 weeks and then Atorvastatin 10mg once daily for 12 weeks
干预措施: Atorvastatin 10mg (Drug)
Control group
Placebo once daily for 12 weeks and then Atorvastatin 10mg once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Response rate of 12 weeks of atorvastatin in experimental group and 12 weeks of placebo in control group
时间窗: 12 weeks
A responder is defined as a case in which the percentage change in spleen stiffness decreased by 10% or more from baseline after 12 weeks of atorvastatin or placebo administration. When the ratio of the number of responders to the number of participants in each group is defined as the response rate, there is a difference in the response rates between the experimental group and the control group.
次要结局
- Response rate of 12 weeks of placebo in control group and 12 weeks of atorvastatin in control group(12 weeks)
- Adverse events(24 weeks)
- Response rate of 12 weeks of placebo in control group and 24 weeks of atorvastatin in experimental group(24 weeks)
- Response rate of 12 weeks of atorvastatin in experimental group and 24 weeks of atorvastatin in experimental group(24 weeks)
研究者
Dong Hyun Sinn
Professor
Samsung Medical Center