Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial

• Status: Not yet recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate whether atorvastatin can improve portal hypertension in patients with chronic hepatitis B related compensated cirrhosis with portal hypertension

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Atorvastatin

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.)