Statins for treatment of liver cirrhosis. The STATLiver Trial

Phase 1

• Conditions: Cirrhosis of the liver; MedDRA version: 20.0Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-001806-40-DK
• Lead Sponsor: Afsnit 360, Gastroenheden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-22
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

-Patients in the age of 18 to 80 years are eligible for inclusion.
-Patients with liver cirrhosis, diagnosed by liver biopsy, ultrasound or CT scan of the liver and / or clinical biochemistry compatible with cirrhosis are eligible for inclusion.
-Both patients with compensated and decompensated liver disease are eligible for inclusion
-In women, documented absence of pregnancy and unless in menopause commitment to use adequate contraception.
-Clinically significant portal hypertension with a hepatic venous pressure gradient measured by liver vein catheterization >10 mmHg.
-Ability to read and understand project information and give written, informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

-People treated with statins within the last year.
-People with liver cirrhosis, with a clinically verified infection (standard biochemistry, culture) within the last four weeks.
-Pregnancy or lactation.
-Hepatocellular carcinoma
-HIV infection and treatment with protease inhibitors
-People in whom the clinician and investigators may have reason to doubt compliance to trial medication
-Clinical and biochemical signs of hepato-renal syndrome defined by current guidelines within the last 14 days
-A MELD score above 23, or Child-Pugh score higher than 13.
-Hepatic encephalopathy grade 2 or higher

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Add on treatment with atorvastatin 10-20 mg to standard treatment improves survival in patients with cirrhosis of any etiology. ;Secondary Objective: Add on treatment with atorvastatin 10-20 mg to standard treatment delays onset of systemic inflammation and decompensation in cirrhosis of any etiology. <br>Atorvastatin alters macrophage activation and immune response to inflammation in the hepatic stellate cell, by altered expression in the inflammation cascade. <br>Atorvastatin alters protein expression in the hepatic stellate cell and in Kupffer cells.<br>Atorvastatin prevents micro-thrombosis in the small vasculature of the liver.<br>;Primary end point(s): -Composite endpoint of death or liver transplantation after 1.5 and 5 years.<br>-Hospitalization with liver related complications after 1.5 and 5 years. ;Timepoint(s) of evaluation of this end point: 1.5 and 5 years