Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis

• Register: EUCTR
• Last refreshed on: 20 May 2013
• Main ID: EUCTR2005-002160-28-AT
• Date of registration: 19/08/2005
• Prospective Registration: Yes
• Primary sponsor: Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and Hepatology
• Public title: Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis
• Scientific title: Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis
• Date of first enrolment: 23/09/2005
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002160-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: yes Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria (PBC):
LDL-cholesterol >= 130 mg/dl
Primary biliary cirrhosis (AMA positive or biopsy proven)
Male or female gender
Age 18-70 years
Normal kidney function

Inclusion criteria (non-PBC):
LDL-cholesterol >= 130 mg/dl matched for age, gender, glucose metabolism and vascular disease manifestations
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Primary biliary cirrhosis Stage III-IV (Ludwig Score)
Liver cirrhosis
Decompensated liver disease ( > Child-Pugh class B, ascites, esophageal varices)
ALT or AST > 2x ULN
Pregnancy or breastfeeding
Premenopausal women without certain contraception
Known hypersensitivity to HMG-CoA reductase inhibitors



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Reduction of cardiovascular risk may become key for the management of PBC. Therefore information on safety and efficacy (lipid-lowering effects) of statins in chronic cholestatic disorders is essential. Moreover, the study will answer the open question whether long-term treatment with statins may have potential beneficial effects on the course of PBC.

Intervention(s)

Trade Name: Sortis
Product Name: Sortis 10 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Atorvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): LDL-cholesterol (LDL-C)

Secondary Objective: Moreover, we aim to test the hypotheses that the cholesterol-lowering effect of atorvastatin and the safety concerning hepatotoxicity in PBC patients does not differ from non-cholestatic, hypercholesterolemic patients.

Main Objective: Primary biliary cirrhosis (PBC) is often associated with abnormalities in serum lipids. Hypercholesterolemia is an established risk factor for cardiovascular morbidity and mortality. Since many PBC patients have a very slow progression of their underlying liver disease cardiovascular risk factors may become more relevant as prognostic factors. Statins may reduce serum cholesterol levels and cardiovascular risk in PBC patients although this remains to be determined. Statins are generally well tolerated by patients with nonalcoholic fatty liver disease (NAFLD) and are not associated with an increased risk of hepatotoxicity. In regard to cholestatic liver diseases only limited data on safety of statins are available. Atorvastatin did not statistically increase liver enzymes in PBC patients in a recent pilot study at the Medical University Graz. However, data on long-term treatment with atorvastatin in these patients are not yet available.

Secondary ID(s)

hepatology_MT_2005-05