The Effect of Bezafibrate on Cholestatic Itch

Conditions

Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Secondary Sclerosing Cholangitis

Keywords

Pruritus, itch, cholestasis

Brief summary

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

de Vries E, Bolier R, Goet J, Parés A, Verbeek J, de Vree M, Drenth J, van Erpecum K, van Nieuwkerk K, van der Heide F, Mostafavi N, Helder J, Ponsioen C, Oude Elferink R, van Buuren H, Beuers U, Netherlands Association for the Study of the Liver-Cholestasis Working Group.

2020-10-05128 citations

10.1053/j.gastro.2020.10.001

Fibrates for the treatment of cholestatic itch (FITCH): study protocol for a randomized controlled trial.

Bolier R, de Vries ES, Parés A, Helder J, Kemper EM, Zwinderman K, Elferink RPO, Beuers U, Netherlands Association for the Study of the Liver (NASL) Cholestatic Liver Diseases Study Group.

2017-05-2315 citations

10.1186/s13063-017-1966-8

Interventions

DRUGBezafibrate

bezafibrate 400mg per day

DRUGPlacebo

placebo 400mg per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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).

Design outcomes

Primary

Measure	Time frame
Proportion of patients with a reduction in itch intensity of 50% or more	3 weeks

Secondary

Measure	Time frame
Serum liver tests	3 weeks
Serum creatinine	3 weeks
Serum cholesterol	3 weeks
Serum autotaxin activity	3 weeks
Serum creatinin kinase	3 weeks

Countries

Netherlands, Spain

Outcome results

None listed