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Title: Endpoints and design of clinical trials in patients with decompensated cirrhosis: Position paper of the LiverHope Consortium
Author: Solà, Elsa
Pose, Elisa
Campion, Daniela
Piano, Salvatore
Roux, Olivier
Simón Talero, Macarena
Uschner, Frank
de Wit, Koos
Zaccherini, Giacomo
Alessandria, Carlo
Beuers, Ulrich
Caraceni, Paolo
Francoz, Claire
Mookerjee, Rajeshwar P.
Trebicka, Jonel
Vargas, Víctor
Serra, Miquel
Torres, Ferran
Montagnese, Sara
Krag, Aleksander
Hernaez, Rubén
Korenjak, Marko
Watson, Hugh
Abraldes, Juan G.
Kamath, Patrick S.
Ginès i Gibert, Pere
LiverHope consortium investigators
Keywords: Cirrosi hepàtica
Trasplantament hepàtic
Qualitat de vida
Hepatic cirrhosis
Hepatic transplantation
Quality of life
Issue Date: 1-Jan-2021
Publisher: Elsevier
Abstract: Management of decompensated cirrhosis is currently geared towards the treatment of complications once they occur. To date there is no established disease-modifying therapy aimed at halting progression of the disease and preventing the development of complications in patients with decompensated cirrhosis. The design of clinical trials to investigate new therapies for patients with decompensated cirrhosis is complex. The population of patients with decompensated cirrhosis is heterogeneous (i.e., different etiologies, comorbidities and disease severity), leading to the inclusion of diverse populations in clinical trials. In addition, primary endpoints selected for trials that include patients with decompensated cirrhosis are not homogeneous and at times may not be appropriate. This leads to difficulties in comparing results obtained from different trials. Against this background, the LiverHope Consortium organized a meeting of experts, the goal of which was to develop recommendations for the design of clinical trials and to define appropriate endpoints, both for trials aimed at modifying the natural history and preventing progression of decompensated cirrhosis, as well as for trials aimed at managing the individual complications of cirrhosis.
Note: Reproducció del document publicat a:
It is part of: Journal of Hepatology, 2021, vol. 74, num. 1, p. 200-219
Related resource:
ISSN: 0168-8278
Appears in Collections:Articles publicats en revistes (Medicina)
Articles publicats en revistes (Infermeria de Salut Pública, Salut mental i Maternoinfantil)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

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