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

Trials

the Netherlands Association for the Study of the Liver (NASL) Cholestatic Liver Diseases Study Group¹  Koos Zwinderman²  E. Marleen Kemper³  Albert Parés⁴  Elsemieke S. de Vries⁵  Jeltje Helder⁵  Ulrich Beuers⁵  Ronald P. Oude Elferink⁵  Ruth Bolier⁵ 

[1] ;Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center;Department of pharmacy, Academic Medical Center;Liver Unit, Hospital Clínic, IDIBAPS, CIBERehd, Department of Medicine, University of Barcelona;Tytgat Institute for Liver and Intestinal Research, Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam;

关键词: Bezafibrate;    Primary biliary cholangitis;    Primary sclerosing cholangitis;    Secondary sclerosing cholangitis;    Pruritus;    Itch;   

DOI  :  10.1186/s13063-017-1966-8

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown