primary biliary cirrhosis primary sclerosing cholangitis
Conditions
Interventions
Bezafibrate 400mg or placebo
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - age > 18 y - understanding of Dutch, German, English, Spanish or Italian language - Diagnosis of PBC, PSC or SSC as defined by EASL clinical practice guidelines of cholestasis 2009 - itch without primary dermatologic abnormalities and with an intensity score of 5 of higher on a scale from 0 to 10, scored twice within the week before start of the treatment
Exclusion criteria
Exclusion criteria: - concomitant antipruritic therapy - pregnancy - cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as ERCP or surgery - use of opiates - renal insufficiency (creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a 50% reduction of itch intensity on a visual analogue scale (VAS) after bezafibrate treatment, compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To test the effect of bezafibrate on serum autotaxin (ATX) activity in cholestatic patients; - To screen for hepatotoxic and other side effects (rhabdomyolysis, modifications of the lipid profile, nephrotoxic effects) of bezafibrate in cholestatic liver diseases; - To determine the effect of bezafibrate on fatigue and quality of life scores in cholestatic patients. | — |
Countries
Netherlands
Outcome results
None listed