Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000411549
Ethics application status
Not yet submitted
Date submitted
19/09/2006
Date registered
20/09/2006
Date last updated
20/09/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of the effect of telmisartan on fibrosis in fatty liver disease
Scientific title
A study of the safety and effects of AT1 (angiotensin type 1) receptor blockade with the angiotensin receptor II antagonist, telmisartan, on hepatic fibrogenesis in patients with non-alcoholic steatohepatitis (NASH).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic steatohepatitis (NASH) 1378 0
Condition category
Condition code
Inflammatory and Immune System 1471 1471 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 months of oral telmisartan therapy (20-80mg per day). Participants will begin at 20mg and this dose will be increased in 20mg increments until the maximum tolerated dose is reached up to 80mg per day.
Intervention code [1] 1363 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2034 0
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.
Timepoint [1] 2034 0
Measured at 12 months
Secondary outcome [1] 3522 0
Safety and tolerability of angiotensin type 1 (AT1) receptor antagonism in this patient group.
Timepoint [1] 3522 0
Measured during each study visit (initially weekly for the first month then 3 monthly) and at 12 months.
Secondary outcome [2] 3523 0
Effects of telmisartan on insulin resistance
Timepoint [2] 3523 0
Measured during each study visit (initially weekly for the first month then 3 monthly) and at 12 months.

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1610 0
Government body
Name [1] 1610 0
NHMRC project grant
Country [1] 1610 0
Australia
Primary sponsor type
Individual
Name
Professor Peter Angus
Address
Country
Secondary sponsor category [1] 1413 0
None
Name [1] 1413 0
Nil
Address [1] 1413 0
Country [1] 1413 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3053 0
Austin Health
Ethics committee address [1] 3053 0
Ethics committee country [1] 3053 0
Australia
Date submitted for ethics approval [1] 3053 0
Approval date [1] 3053 0
Ethics approval number [1] 3053 0
Ethics committee name [2] 3054 0
Westmead hospital
Ethics committee address [2] 3054 0
Ethics committee country [2] 3054 0
Australia
Date submitted for ethics approval [2] 3054 0
Approval date [2] 3054 0
Ethics approval number [2] 3054 0

Summary
Brief summary
Hepatic steatosis (fatty liver) is now the most common liver disease in western countries and NASH (fatty liver with inflammation) related cirrhosis and its complications is set to become one of the most important causes of liver related morbidity and mortality. It is clear that treatment and control of predisposing factors such as obesity and diabetes can lead to improvement in liver fibrosis (scarring) in patients with NASH however this is not possible in many patients. At present there are no established drug treatments which have been able to prevent liver fibrosis due to NASH.
The renin-angiotensin sysytem (RAS) plays a central role in controlling blood pressure and sodium balance. Angiotensin II (the effector molecule) is a regarded as a key player in the general response to tissue injury in a number of organ systems, including the liver. A number of studies (experimental and human) have shown an improvement in fibrosis when the effects of AII are blocked.
This study will assess the ability of telmisartan therapy to decrease the formation of fat and scar tissue in the liver in patients with fatty liver disease. It will also study the effects of telmisartan on other factors commonly found in patients with fatty liver including obesity and insulin resistance. Telmisartan will be given for a period of 12 months. A liver biopsy will be performed prior to enrolment and then at 12 months. At each visit (3 monthly after the first month) a blood sample and medical consultation will be performed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27590 0
Address 27590 0
Country 27590 0
Phone 27590 0
Fax 27590 0
Email 27590 0
Contact person for public queries
Name 10552 0
Dr Steve Lontos
Address 10552 0
Department of Gastroenterology
Austin Health
PO BOX 5555
Heidelberg VIC 3084
Country 10552 0
Australia
Phone 10552 0
+61 3 94963659
Fax 10552 0
+61 3 94963487
Email 10552 0
Steve.Lontos@austin.org.au
Contact person for scientific queries
Name 1480 0
Professor Peter Angus
Address 1480 0
Department of Gastroenterology
Austin Health
PO BOX 5555
Heidelberg VIC 3084
Country 1480 0
Australia
Phone 1480 0
+61 3 94965582
Fax 1480 0
+61 3 94963487
Email 1480 0
Peter.Angus@austin.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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