Clinical trial NCT05483894: Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial
Official title: Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatitis B
Portal Hypertension
Keywords: Atorvastatin
HBV- Related Liver Cirrhosis
Portal Hypertension
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

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.)

Primary outcomes:
measure: Response rate of 12 weeks of atorvastatin in experimental group and 12 weeks of placebo in control group
timeFrame: 12 weeks
Secondary outcomes:
measure: Response rate of 12 weeks of atorvastatin in experimental group and 24 weeks of atorvastatin in experimental group
timeFrame: 24 weeks
measure: Response rate of 12 weeks of placebo in control group and 24 weeks of atorvastatin in experimental group
timeFrame: 24 weeks
measure: Response rate of 12 weeks of placebo in control group and 12 weeks of atorvastatin in control group
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
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