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To evaluate whether atorvastatin can improve portal hypertension in patients with chronic hepatitis B related compensated cirrhosis with portal hypertension
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Active Comparator | Atorvastatin 10mg once daily for 24 weeks |
|
| Control group | Placebo Comparator | Placebo once daily for 12 weeks and then Atorvastatin 10mg once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin 10mg | Drug | Atorvastatin 10mg(Lipinon Tab. 10mg) once daily for 24 weeks for experimental group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of 12 weeks of atorvastatin in experimental group and 12 weeks of placebo in control group | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of 12 weeks of atorvastatin in experimental group and 24 weeks of atorvastatin in experimental group | 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. |
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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.
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
If the serum HBV DNA is well controlled to 2000 International Unit (IU)/mL or less while taking antiviral treatment
When the splenic elasticity measured by two-dimensional shear wave elastography is greater than 25 kilopascal(kPa)
When informed consent is possible
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo once daily for 12 weeks and than Atorvastatin(Lipinon Tab. 10mg) for 12 weeks for control group |
|
| 24 weeks |
| Response rate of 12 weeks of placebo in control group and 24 weeks of atorvastatin in experimental group | 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. | 24 weeks |
| Response rate of 12 weeks of placebo in control group and 12 weeks of atorvastatin in control group | 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. | 12 weeks |
| Adverse events | Frequency of adverse events (hepatotoxicity, muscle toxicity) after atorvastatin administration | 24 weeks |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |