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

NCT ID: NCT05483894

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2025-01-31

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.

Conditions

Hepatitis B; Portal Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group

Atorvastatin 10mg once daily for 24 weeks

Group Type: ACTIVE_COMPARATOR

Atorvastatin 10mg

Intervention Type: DRUG

Atorvastatin 10mg(Lipinon Tab. 10mg) once daily for 24 weeks for experimental group

Control group

Placebo once daily for 12 weeks and then Atorvastatin 10mg once daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Atorvastatin 10mg

Intervention Type: DRUG

Atorvastatin 10mg(Lipinon Tab. 10mg) once daily for 24 weeks for experimental group

Placebo

Intervention Type: DRUG

Placebo once daily for 12 weeks and than Atorvastatin(Lipinon Tab. 10mg) for 12 weeks for control group

Interventions

Atorvastatin 10mg

Atorvastatin 10mg(Lipinon Tab. 10mg) once daily for 24 weeks for experimental group

Intervention Type: DRUG

Placebo

Placebo once daily for 12 weeks and than Atorvastatin(Lipinon Tab. 10mg) for 12 weeks for control group

Intervention Type: DRUG

Other Intervention Names

Lipinon Tab. 10mg

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.)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dong Hyun Sinn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SMC 2021-06-205-001

Identifier Type: -

Identifier Source: org_study_id