Statins for prevention of disease progression and hospitalization in Liver Cirrhosis: A multi-center, randomized, double blind, placebo-controlled trial. The STATLiver Trial. - STATLiver Trial

Afsnit 360, Gastroenheden0 个研究点目标入组 182 人开始时间: 2019年5月22日最近更新: 2020年8月10日

试验速览

暂无简介。

•-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

•-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

发起方

Afsnit 360, Gastroenheden