Fibrotic liver disease by hospitalization and losartan as antifibrotic therapy in patients with alcoholic liverdisease

Phase 1

Conditions: 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: 14.1Level: PTClassification code 10001627Term: Alcoholic liver diseaseSystem Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 14.1Level: LLTClassification code 10001626Term: Alcoholic liver damage, unspecifiedSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-006227-38-DK

Lead Sponsor: Ove B. Schaffalitzky de Muckadell

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

- 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.