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 range19 Years – 69 Years

SexALL

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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
✕. 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

What they're measuring

Response rate of 12 weeks of atorvastatin in experimental group and 12 weeks of placebo in control group

Timeframe: 12 weeks

Trial details

NCT IDNCT05483894

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

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