Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT05483894
Eligibility Criteria:
Inclusion Criteria:
1. Adults between 19 and 69 years of age
2. If HBsAg positivity has been observed for more than 6 months or a clinical history of chronic hepatitis B is confirmed
3. 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
4. If the serum HBV DNA is well controlled to 2000 International Unit (IU)/mL or less while taking antiviral treatment
5. When the splenic elasticity measured by two-dimensional shear wave elastography is greater than 25 kilopascal(kPa)
6. When informed consent is possible
Exclusion Criteria:
1. Hepatitis C or HIV co-infected person
2. Those who continuously drink more than the standard (alcohol intake exceeding 20g per day)
3. In case of decreased liver function with Child Pugh score of 7 or higher
4. History of decompensated cirrhosis: history of ascites, spontaneous bacterial peritonitis, hepatic coma, varicose bleeding, hepatic nephrotic syndrome
5. 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))
6. If there is a serious comorbidity whose life expectancy is estimated to be less than 3 years
7. In case of chronic kidney disease estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2
8. If portal vein thrombosis is diagnosed
9. Previous intrahepatic portal vein shunt intervention or liver transplantation
10. A history of statin administration within the last 2 years
11. In case of side effects from previous statin administration (drug-related hepatotoxicity, muscle toxicity, allergic reaction, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
69 Years
Study:
NCT05483894
Study Brief:
Protocol Section:
NCT05483894