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

Autor: Bolier, R., Vries, E.S. de, Pares, A., Helder, J., Kemper, E.M., Zwinderman, K., Elferink, R.P., Beuers, U., Buuren, H.R. van, Drenth, J.P., Erpecum, K.J. van, Hoek, B. van, Jansen, P.L.M., Nieuwkerk, K.M. van, Vree, J.M. de
Přispěvatelé: Tytgat Institute for Liver and Intestinal Research, Gastroenterology and Hepatology, Pharmacy, APH - Methodology, Epidemiology and Data Science, Other departments, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Universitat de Barcelona
Jazyk: angličtina
Rok vydání: 2017
Předmět:
medicine.medical_specialty
Time Factors
Visual analogue scale
Cholangitis
Sclerosing
Medicine (miscellaneous)
Secondary sclerosing cholangitis
Placebo
Itch
law.invention
Primary sclerosing cholangitis
Study Protocol
03 medical and health sciences
0302 clinical medicine
Clinical Protocols
Double-Blind Method
Randomized controlled trial
law
Internal medicine
Humans
Medicine
Bile ducts
Pharmacology (medical)
Adverse effect
Liver diseases
Netherlands
Cholestatic pruritus
lcsh:R5-920
Bezafibrate
Liver Cirrhosis
Biliary
business.industry
Malalties del fetge
Pruritus
Primary biliary cholangitis
Antipruritics
medicine.disease
Surgery
Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11]
Treatment Outcome
Research Design
Spain
Conductes biliars
030220 oncology & carcinogenesis
030211 gastroenterology & hepatology
lcsh:Medicine (General)
business
medicine.drug
Zdroj: Trials
Trials, 18
Trials, 18(1). BioMed Central
Recercat. Dipósit de la Recerca de Catalunya
instname
Dipòsit Digital de la UB
Universidad de Barcelona
Trials, Vol 18, Iss 1, Pp 1-9 (2017)
ISSN: 1745-6215
Popis: 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. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1966-8) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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