drugset / Trial / NCT02701166
The Effect of Bezafibrate on Cholestatic Itch
Phase 3
Unknown
84 enrolled
Academic Medical Center - University of Amsterdam
Erasmus Medical Center · collabFriedrich-Alexander-Universität Erlangen-Nürnberg · collabIstituto Clinico Humanitas · collabLeiden University Medical Center · collabLudwig-Maximilians - University of Munich · collabMaastricht University Medical Center · collabRadboud University Medical Center · collabUMC Utrecht · collabUniversitair Ziekenhuis Brussel · collabUniversity Medical Center Groningen · collabUniversity of Barcelona · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Randomized double blind placebo controlled trial to evaluate the antipruritic effect of bezafibrate in patients with moderate to severe cholestatic itch.
Timeline
- Start
- 2016-02
- Primary completion
- 2018-02
- Completion
- 2018-04
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bezafibrate | Small molecule | 400 mg | — |