Assessment of fibrotic liver disease in a medical admission ward and intervention with losartan as antifibrotic therapy in patients with alcoholic liverdisease” - Losartan as antifibrotic teraphy in patients with early stages of fibrotic alcoholic liverdisease

Ove B. Schaffalitzky de Muckadell0 个研究点开始时间: 2012年3月5日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•- Men and women aged 18 to 75 years.
•- Alcoholconsumption corresponding to an assumed average alcohol intake of = 40 g alcohol daily for more than 3 years.
•- Presence of significant or advanced fibrotic liver disease (Metavir F2 / F3) diagnosed by liver biopsy or elastiometric ultrasound with cut-off = 8 kPa.
•- Women of childbearing potential must agree to use adequate contraception.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 110
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 110

•- Known cirrhosis confirmed by biopsy
•- Clinically decompensated cirrhosis determined by the presence of ascites (former or known by elastiographic ultrasoundinvestigation) or eusofagusvariser.
•- Elastiographic value (stiffness) <8 kPa.
•- Pregnancy
•- Co-morbidity in the form of viral hepatitis (HBV or HCV), HIV, BMI > 30
•- Unwillingness or inability to accept participation in the trial
•- Current treatment with an ACE inhibitor or Angiotensin II antagonists
•- Previous allergic reaction to Angiotensin II antagonists. Specific questioning of angioedema.
•- Hypotension with clinical symptoms, where it is deemed medically irresponsible to intervene with antihypertensive medication.

发起方

Ove B. Schaffalitzky de Muckadell