The effect of bezafibrate on itch in liver disease

-Age ≥ 18 years;
-Understanding of Dutch, English, German, Spanish or Italian language;

-Diagnosed with primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC) or secondary sclerosing cholangitis (as defined by EASL clinical practice guidelines of cholestasis 2009 [19]).

-Itch without primary dermatologic abnormalities and with an intensity score of ≥ 5.0 cm on a scale from 0.0 cm (no itch) to 10.0 cm (worst itch possible), scored twice in the week before inclusion.

-Concomitant guideline-recommended as well as experimental antipruritic therapy, e.g. rifampicin, opioid-receptor antagonists (naltrexon, naloxone), serotonin-reuptake inhibitors (sertraline), ondansetron, phenobarbital, propofol, lidocaine, dronabinol, butorphanol, internal or external biliary drainage, extracorporeal albumin dialysis, ultraviolet-B phototherapy;

NB. Topical menthol containing agents are allowed, as well as bile salt sequestrants (colesevelam, cholestyramin) as long as taken at least 4 hours before or after intake of the study medication. Incidental use of these agents should be noted by patients in the diary, structural use should be noted on the CRF (section co-medication);

-Pregnancy, women of childbearing potential not using contraception, breast feeding;

-Cholestasis due to obstruction that requires invasive desobstructive treatment within the time scope of the study (5 weeks), such as endoscopic retrograde cholangiopancreaticography (ERCP) or surgical removal of a tumour compressing the bile duct;

-Use of opiates;

-Renal insufficiency (creatinine clearance <60mL/min per 1.73m2).