Back to resultsAtorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial (STAPH)
Primary Purpose
Hepatitis B, Portal Hypertension
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Atorvastatin 10mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B focused on measuring Atorvastatin, HBV- Related Liver Cirrhosis, Portal Hypertension
Eligibility 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.
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:
- Hepatitis C or HIV co-infected person
- Those who continuously drink more than the standard (alcohol intake exceeding 20g per day)
- In case of decreased liver function with Child Pugh score of 7 or higher
- History of decompensated cirrhosis: history of ascites, spontaneous bacterial peritonitis, hepatic coma, varicose bleeding, hepatic nephrotic syndrome
- 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))
- If there is a serious comorbidity whose life expectancy is estimated to be less than 3 years
- In case of chronic kidney disease estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
- If portal vein thrombosis is diagnosed
- Previous intrahepatic portal vein shunt intervention or liver transplantation
- A history of statin administration within the last 2 years
- In case of side effects from previous statin administration (drug-related hepatotoxicity, muscle toxicity, allergic reaction, etc.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
Atorvastatin 10mg once daily for 24 weeks
Placebo once daily for 12 weeks and then Atorvastatin 10mg once daily for 12 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Adverse events
Frequency of adverse events (hepatotoxicity, muscle toxicity) after atorvastatin administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05483894
Brief Title
Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial
Acronym
STAPH
Official Title
Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Portal Hypertension
Keywords
Atorvastatin, HBV- Related Liver Cirrhosis, Portal Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
Atorvastatin 10mg once daily for 24 weeks
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo once daily for 12 weeks and then Atorvastatin 10mg once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 10mg
Other Intervention Name(s)
Lipinon Tab. 10mg
Intervention Description
Atorvastatin 10mg(Lipinon Tab. 10mg) once daily for 24 weeks for experimental group
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily for 12 weeks and than Atorvastatin(Lipinon Tab. 10mg) for 12 weeks for control group
Primary Outcome Measure Information:
Title
Response rate of 12 weeks of atorvastatin in experimental group and 12 weeks of placebo in control group
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Response rate of 12 weeks of atorvastatin in experimental group and 24 weeks of atorvastatin in experimental group
Description
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.
Time Frame
24 weeks
Title
Response rate of 12 weeks of placebo in control group and 24 weeks of atorvastatin in experimental group
Description
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.
Time Frame
24 weeks
Title
Response rate of 12 weeks of placebo in control group and 12 weeks of atorvastatin in control group
Description
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.
Time Frame
12 weeks
Title
Adverse events
Description
Frequency of adverse events (hepatotoxicity, muscle toxicity) after atorvastatin administration
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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:
Hepatitis C or HIV co-infected person
Those who continuously drink more than the standard (alcohol intake exceeding 20g per day)
In case of decreased liver function with Child Pugh score of 7 or higher
History of decompensated cirrhosis: history of ascites, spontaneous bacterial peritonitis, hepatic coma, varicose bleeding, hepatic nephrotic syndrome
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))
If there is a serious comorbidity whose life expectancy is estimated to be less than 3 years
In case of chronic kidney disease estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
If portal vein thrombosis is diagnosed
Previous intrahepatic portal vein shunt intervention or liver transplantation
A history of statin administration within the last 2 years
In case of side effects from previous statin administration (drug-related hepatotoxicity, muscle toxicity, allergic reaction, etc.)
12. IPD Sharing Statement
Learn more about this trial
Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial
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