Atorvastatin Use and Portal Hypertension in Patients With Hepatitis B Virus-related Liver Cirrhosis: A Randomized Controlled Trial

NCT05483894 | Unknown Phase 2 DMC

• 1 other identifier: SMC 2021-06-205-001
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate whether atorvastatin can improve portal hypertension in patients with chronic hepatitis B related compensated cirrhosis with portal hypertension

Conditions

Hepatitis B; Portal Hypertension

Keywords

Atorvastatin; HBV- Related Liver Cirrhosis; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Response rate of 12 weeks of atorvastatin in experimental group and 24 weeks of atorvastatin in experimental group

  24 weeks

• Response rate of 12 weeks of placebo in control group and 24 weeks of atorvastatin in experimental group

  24 weeks

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

  12 weeks

• Adverse events

  24 weeks

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Atorvastatin 10mg once daily for 24 weeks

Drug: Atorvastatin 10mg

Control group

PLACEBO COMPARATOR

Placebo once daily for 12 weeks and then Atorvastatin 10mg once daily for 12 weeks

Drug: Atorvastatin 10mg; Drug: Placebo

Interventions

Atorvastatin 10mg DRUG

Atorvastatin 10mg(Lipinon Tab. 10mg) once daily for 24 weeks for experimental group

Also known as: Lipinon Tab. 10mg

Control group; Experimental group

Placebo DRUG

Placebo once daily for 12 weeks and than Atorvastatin(Lipinon Tab. 10mg) for 12 weeks for control group

Control group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Hepatitis B; Hypertension, Portal

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 2, 2022
• Study Start: August 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: January 31, 2025
• Last Updated: August 2, 2022

Record last verified: 2022-07