Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhos… (NCT05483894) | Clinical Trial Compass
UnknownPhase 2
Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial
36 participantsStarted 2022-08-01
Plain-language summary
To evaluate whether atorvastatin can improve portal hypertension in patients with chronic hepatitis B related compensated cirrhosis with portal hypertension
Who can participate
Age range
19 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Response rate of 12 weeks of atorvastatin in experimental group and 12 weeks of placebo in control group
. 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