Fibrotic alcoholic liver disease is in early stages often completely asymptomatic. Fully developed cirrhosis affect a wide range of physiological conditions. Eksamples are portal hypertension and following ascites and oesofagus varices. Serious sequelae of liver failure, in the form of hepatic encephalopathy and impaired synthesis of albumin and clotting factors are also seen. The prognosis is at this stage of disease progression extremely poor. MedDRA version: 14.1 Level: PT Classification cod
Conditions
Interventions
Trade Name: Losartankalium
Pharmaceutical Form: Capsule
CAS Number: 124750-99-8
Other descriptive name: LOSARTAN POTASSIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
Ove B. Schaffalitzky de Muckadell
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Fibrotic liver disease traditionally seen as an irreversible condition. Angiotensin II receptor antagonists in animal studies has been shown to have an inhibitory effect on the development of liver fibrosis and these findings are backed up in small human studies. Molecular biological studies, animal studies and small human studies support the hypothesis that Angiotensin II receptor inhibitors in therapeutic doses has a antifibrotisk potential in patients with precirrhotic alcoholic liver disease. The main purpose of this study is to investigate whether losartan at therapeutic dose after 12 months has a antifibrotic effect on pin patients with precirrhotic alcoholic liver fibrosis.;Secondary Objective: There is no established secondary objective of this study.;Primary end point(s): Significant difference in grade of fibrosis in liver biopsies and by elastiometric ultrasoundinvestigation before and after 12 months of treatment with losartan 50 mg x 1 daily.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Significant difference in the frequency of upper gastrointestinal bleeding episodes. Bleeding Episode is defined by: --- Significant or unexplained hemoglobin decrease --- Verified by gastroscopy (objective signs of active or new bleeding. Significant difference in the incidence of ascites. A distinction is made between: Grade 0: Neither clinical or ultrasound demonstrated ascites Grade 1: No clinical ascites, but ascites easily seen by ultrasound. Grade 2: Ascites can be recognized by basic clinical examination. Grade 3: Visible ascites.;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Denmark
Contacts
Public ContactUnit of research
Odense University Hospital
Outcome results
None listed