The Effect of Bezafibrate on Cholestatic Itch (FITCH)
Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing Cholangitis
About this trial
This is an interventional treatment trial for Primary Biliary Cholangitis focused on measuring Pruritus, itch, cholestasis
Eligibility Criteria
Inclusion Criteria:
- diagnosis of primary biliary cholangitis or primary/secondary sclerosing cholangitis as defined by EASL clinical practice guidelines of cholestasis 2009;
- 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.
Exclusion Criteria:
- 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 tumor compressing the bile duct;
- Use of opiates;
- Renal insufficiency (creatinine clearance <60mL/min).
Sites / Locations
- Academic Medical CenterRecruiting
- Vrije Universiteit Medisch CentrumRecruiting
- Universitair Medisch Centrum GroningenRecruiting
- Leids Universitair Medisch CentrumRecruiting
- Maastricht Universitair Medisch CentrumRecruiting
- Radboud Universitair Medisch CentrumRecruiting
- Erasmus Medisch CentrumRecruiting
- Universitair Medisch Centrum UtrechtRecruiting
- University of Barcelona
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Bezafibrate
Placebo
Bezalip retard 400mg tablet
Placebo 400mg tablet