Study of the effect of telmisartan on fibrosis in fatty liver disease
- Conditions
- on-alcoholic steatohepatitis (NASH)Non-alcoholic steatohepatitis (NASH)Inflammatory and Immune System - Liver
- Registration Number
- ACTRN12606000411549
- Lead Sponsor
- Professor Peter Angus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
Stable body weight ( change of < 3%) for the last 6 months• Undergone 6 months of a diet and exercise regimen to help improve liver function tests• Non diabetic or well controlled diabetes • Abnormal liver function tests in patients with fatty liver disease• Haemaglobin > 10g/dL• Platelets >70,000/mm3• Prothrombin time < 2 sec prolonged • Serum creatinine < .15 mmol/l
Female patients of child bearing potential who are not using an accepted method of birth control (surgically sterile, intra-uterine device, oral contraceptives, hormone delivery systems, diaphragm or condom in combination with contraceptive cream or foam), or female patients who are pregnant or breastfeeding. A pre-enrolment serum or urinary HCG (human chorionic gonadotrophin) must be negative;• Infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human Immunodeficiency Virus (HIV)• Other chronic liver diseases• Significant weight gain or loss in the 3 months prior to study• Unstable diabetes• Patients with significant renal impairment (creatinine > .15 mm/l)• Patients with systolic BP <110 mmHg• Patients with decompensated liver disease ( Childs Pugh score >6 )• Patients who have participated in a clinical trial for an investigational drug (a new chemical not registered for clinical use) within 30 days preceding entry into the study, or who are due to enter such a trial during the treatment period• Substance abuse such as alcohol (>30g/day for males, >20g/day for females), IV and inhaled drugs. If there has been a history of substance abuse, the subject must have abstained from using for at least 2 years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to assess the effects of blockade of the angiotensin type 1 (AT1) receptor with the angiotensin receptor II antagonist, telmisartan, on hepatic fibrogenesis in patients with non-alcoholic steatohepatitis.[Measured at 12 months]
- Secondary Outcome Measures
Name Time Method Safety and tolerability of angiotensin type 1 (AT1) receptor antagonism in this patient group.[Measured during each study visit (initially weekly for the first month then 3 monthly) and at 12 months.];Effects of telmisartan on insulin resistance[Measured during each study visit (initially weekly for the first month then 3 monthly) and at 12 months.]