STAPH: Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial
Study Details
Study Description
Brief Summary
To evaluate whether atorvastatin can improve portal hypertension in patients with chronic hepatitis B related compensated cirrhosis with portal hypertension
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Experimental group Atorvastatin 10mg once daily for 24 weeks |
Drug: Atorvastatin 10mg
Atorvastatin 10mg(Lipinon Tab. 10mg) once daily for 24 weeks for experimental group
Other Names:
|
| Placebo Comparator: Control group Placebo once daily for 12 weeks and then Atorvastatin 10mg once daily for 12 weeks |
Drug: Atorvastatin 10mg
Atorvastatin 10mg(Lipinon Tab. 10mg) once daily for 24 weeks for experimental group
Other Names:
Drug: Placebo
Placebo once daily for 12 weeks and than Atorvastatin(Lipinon Tab. 10mg) for 12 weeks for control group
|
Outcome Measures
Primary Outcome Measures
- Response rate of 12 weeks of atorvastatin in experimental group and 12 weeks of placebo in control group [12 weeks]
A responder is defined as a case in which the percentage change in spleen stiffness decreased by 10% or more from baseline after 12 weeks of atorvastatin or placebo administration. When the ratio of the number of responders to the number of participants in each group is defined as the response rate, there is a difference in the response rates between the experimental group and the control group.
Secondary Outcome Measures
- Response rate of 12 weeks of atorvastatin in experimental group and 24 weeks of atorvastatin in experimental group [24 weeks]
After 12 weeks of atorvastatin administration, the response rate of the experimental group in which the percentage change in spleen stiffness decreased by 10% or more compared to the baseline value after 12 weeks of administration is different from the response rate after 24 weeks of the experimental group, in which the percentage change in spleen stiffness decreased by more than 10% compared to the baseline after 24 weeks of administration.
- Response rate of 12 weeks of placebo in control group and 24 weeks of atorvastatin in experimental group [24 weeks]
The response rate after 12 weeks of placebo administration in the control group is different from the response rate after 24 weeks of atorvastatin administration in the experimental group.
- Response rate of 12 weeks of placebo in control group and 12 weeks of atorvastatin in control group [12 weeks]
The response rate after 12 weeks of placebo administration in the control group is different from the response rate after 12 weeks of atorvastatin administration (24 weeks after the start of the study) in the control group at 12 weeks.
- Adverse events [24 weeks]
Frequency of adverse events (hepatotoxicity, muscle toxicity) after atorvastatin administration
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adults between 19 and 69 years of age
-
If HBsAg positivity has been observed for more than 6 months or a clinical history of chronic hepatitis B is confirmed
-
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.
- 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
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If the serum HBV DNA is well controlled to 2000 International Unit (IU)/mL or less while taking antiviral treatment
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When the splenic elasticity measured by two-dimensional shear wave elastography is greater than 25 kilopascal(kPa)
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When informed consent is possible
Exclusion Criteria:
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Hepatitis C or HIV co-infected person
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Those who continuously drink more than the standard (alcohol intake exceeding 20g per day)
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In case of decreased liver function with Child Pugh score of 7 or higher
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History of decompensated cirrhosis: history of ascites, spontaneous bacterial peritonitis, hepatic coma, varicose bleeding, hepatic nephrotic syndrome
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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))
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If there is a serious comorbidity whose life expectancy is estimated to be less than 3 years
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In case of chronic kidney disease estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
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If portal vein thrombosis is diagnosed
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Previous intrahepatic portal vein shunt intervention or liver transplantation
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A history of statin administration within the last 2 years
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In case of side effects from previous statin administration (drug-related hepatotoxicity, muscle toxicity, allergic reaction, etc.)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Samsung Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMC 2021-06-205-001