Clinical trial NCT02701166: The Effect of Bezafibrate on Cholestatic Itch
Official title: The Effect of Bezafibrate on Cholestatic Itch
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Primary Biliary Cholangitis
Primary Sclerosing Cholangitis
Secondary Sclerosing Cholangitis
Keywords: Pruritus
itch
cholestasis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: University Medical Center Groningen
name: Leiden University Medical Center
name: UMC Utrecht
name: Radboud University Medical Center
name: Maastricht University Medical Center
name: Free University Medical Center
name: University of Barcelona
name: Ludwig-Maximilians - University of Munich
name: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Istituto Clinico Humanitas
First posted: 2016-03-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: Proportion of patients with a reduction in itch intensity of 50% or more
timeFrame: 3 weeks
Secondary outcomes:
measure: Serum liver tests
timeFrame: 3 weeks
measure: Serum creatinine
timeFrame: 3 weeks
measure: Serum cholesterol
timeFrame: 3 weeks
measure: Serum autotaxin activity
timeFrame: 3 weeks
measure: Serum creatinin kinase
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Barcelona
country: Spain
facility: University of Barcelona
Study officials:
References:
citation: de Vries E, Bolier R, Goet J, Pares 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. Fibrates for Itch (FITCH) in Fibrosing Cholangiopathies: A Double-Blind, Randomized, Placebo-Controlled Trial. Gastroenterology. 2021 Feb;160(3):734-743.e6. doi: 10.1053/j.gastro.2020.10.001. Epub 2020 Oct 5.
citation: Bolier R, de Vries ES, Pares 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. Fibrates for the treatment of cholestatic itch (FITCH): study protocol for a randomized controlled trial. Trials. 2017 May 23;18(1):230. doi: 10.1186/s13063-017-1966-8.