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
- Conditions
- Diseases of the digestive system
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 406
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
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Risk of developing hepatocellular carcinoma in the test group (take 10/20 milligrams of atobamib tablets) and the control group (non-dose) in patients with chronic hepatitis B accompanied by fatty liver.
- Secondary Outcome Measures
Name Time Method The incidence of hepatocellular carcinoma in the test group and the control group.;Death of all causes in the test group and the control group.;Whether the test group and the control group have a new liver disease.;The rate of significant liver dysfunction in the test group and the control group (AST or ALT levels) are If it has more than tripled at the baseline level);Laboratory tests, vital signs, combined drugs, adverse reactions.