The Effect of Bezafibrate on Cholestatic Itch (FITCH)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase

Unknown

Phase 3

Conditions

Primary Sclerosing Cholangitis

Primary Biliary Cholangitis

Secondary Sclerosing Cholangitis

Treatments

Drug: Placebo

Drug: Bezafibrate

Study type

Interventional

Funder types

Other

Identifiers

NCT02701166

NL48885.018.15

Details and patient eligibility

About

Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).