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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Ruth Bolier, Elsemieke S. de Vries, Albert Parés, Jeltje Helder, E. Marleen Kemper, Koos Zwinderman, Ronald P. Oude Elferink, Ulrich Beuers, the Netherlands Association for the Study of the Liver (NASL) Cholestatic Liver Diseases Study Group

Published in: Trials | Issue 1/2017

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Abstract

Background

Pruritus (itch) is a frequent, burdensome and difficult-to-treat symptom in patients with cholestasis. Fibrates are currently under investigation for the treatment of primary biliary cholangitis in patients with a suboptimal response to ursodeoxycholic acid. Moreover, there is empirical evidence for a possible antipruritic effect. We aim to prove this in a randomized controlled trial, including patients with cholestatic liver diseases other than primary biliary cholangitis that are accompanied by pruritus.

Methods

A multicenter investigator-initiated, double-blind, randomized placebo-controlled trial to evaluate the effect of bezafibrate on cholestatic pruritus in 84 adult patients with primary biliary cholangitis or primary/secondary sclerosing cholangitis. Primary outcome is the proportion of patients with a reduction of itch intensity of 50% or more (measured on a Visual Analog Scale) after 21 days of treatment with bezafibrate 400 mg qid or placebo. Secondary outcomes include the effect of bezafibrate on a five-dimensional itch score, liver disease-specific quality of life, serum liver tests and autotaxin activity. Safety will be evaluated through serum parameters for kidney function and rhabdomyolysis as well as precise recording of (serious) adverse events. We provide a schematic overview of the study protocol and describe the methods used to recruit and randomize patients, collect and handle data and perform statistical analyses.

Discussion

Given its favorable safety profile and anticholestatic properties, bezafibrate may become the new first-line treatment option for treating cholestatic pruritus.

Trial registration

Netherlands Trial Register, ID: NCT02701166. Registered on 2 March 2016;
Netherlands Trial Register, ID: NTR5436. Registered on 3 August 2015.
Appendix
Available only for authorised users
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Metadata
Title
Fibrates for the treatment of cholestatic itch (FITCH): study protocol for a randomized controlled trial
Authors
Ruth Bolier
Elsemieke S. de Vries
Albert Parés
Jeltje Helder
E. Marleen Kemper
Koos Zwinderman
Ronald P. Oude Elferink
Ulrich Beuers
the Netherlands Association for the Study of the Liver (NASL) Cholestatic Liver Diseases Study Group
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1966-8

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