KCT0007011尚未招募未知
Multicenter, randomized, open-label, prospective comparative study on the effect of statin/ezetimibe combination use on hepatocellular carcinoma incidence in patients with cirrhosis due to chronic hepatitis B accompanied by fatty liver
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 406
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 60?(Year)（—）
- 性别
- All
入选标准
- •1. Adult men and women aged 19 and over and under 60 years of age
- •2. Patients diagnosed with fatty liver (CAP value >238 dB/m)
- •3. Domestic chronic hepatitis B patients
- •4. Patients with preserved liver function (Child-Pugh Score of A)
- •5. Patients without dyslipidemia requiring statin use
- •6. Cirrhosis patients (Patients with FibroScan Fibrosis Score of F4)
- •7. Patients willing and able to sign the Investigational Consent Form (ICF) and comply with protocol requirements
排除标准
- •1. Patients with a history of liver cancer before the start of the study.
- •2. Patients with confirmed or suspected hepatocellular carcinoma.
- •3. Person with a history of liver failure.
- •4. People with significant liver dysfunction (ALT or AST figures > 120 IU/L)
- •5. Muscle disease patients.
- •6. Subjects who need to administer or administer gampibrozyl, fucidic acid, or potent CYP3A4 inhibitors
- •7. A person who has allergic reactions to Atorvastatin or Ezetimibe or is prohibited from using it.
- •8. Alcoholic or narcotic addicts.
- •9. Pregnant or breastfeeding.
- •10. Patients receiving Glecafrevir and Fibrentasvir
- •11. Galactose intolerance, Lapp lactase deficiency
- •Deficiency, glucose-galactose malabsorption, etc.
- •A patient with genetic problems.
- •12. Severe anemia patients: Hb level <10 g/dL for men and <9 g/dL for women
- •13. Person with hemorrhagic predisposition: platelet count <100,000/µl or PTINR> 1.7
- •(However, he is taking anticoagulants for therapeutic purposes and tested while taking anticoagulants)
- •Registration is possible if the PTINR level exceeds 1.7.)
- •14. Subjects who are unable to implement the clinical trial process specified in the plan.
- •15. Employees of researchers or research institutes directly related to this study.
- •16. Women who cannot be contraceptive during the study period.
- •17. They are currently being administered drugs for clinical trials or other within 3 months prior to participation in this clinical trial.
- •Those who participated in clinical trials.
- •18. Life expectancy is 6 months due to malignant tumors or other serious health conditions affecting life.
- •Those who are judged to be less than that.
- •19. A person undergoing cyclosporine or protease therapy.
- •20. Patients with impaired kidney function: GFR 60mL/min/less than 1.73m2 or creatine clearance,
- •Less than 60mL/min.
- •21. Other persons who judge that they are inappropriate to participate in clinical trials as judged by the tester.
研究者
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