TY  - JOUR
A1  - Solà, Elsa
A1  - Pose Mendez, Elisa
A1  - Campion, Daniela
A1  - Piano, Salvatore
A1  - Roux, Olivier
A1  - Simon-Talero, Macarena
A1  - Uschner, Frank Erhard
A1  - Wit, Koos de
A1  - Zaccherini, Giacomo
A1  - Alessandria, Carlo
A1  - Beuers, Ulrich
A1  - Caraceni, Paolo
A1  - Francoz, Claire
A1  - Mookerjee, Rajeshwar Prosad
A1  - Trebicka, Jonel
A1  - Vargas Blasco, Victor Manuel
A1  - Serra, Miquel
A1  - Torres, Ferran
A1  - Montagnese, Sara
A1  - Krag, Aleksander
A1  - Hernaez, Ruben
A1  - Korenjak, Marko
A1  - Watson, Hugh
A1  - Abraldes, Juan G.
A1  - Kamath, Patrick S.
A1  - Ginès, Pere
T1  - Endpoints and design of clinical trials in patients with decompensated cirrhosis: Position paper of the LiverHope Consortium
T2  - Journal of hepatology
N2  - 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.
KW  - Cirrhosis
KW  - Liver transplant
KW  - Clinical trials
KW  - Endpoints
KW  - Ascites
KW  - AKI
KW  - Hepatic encephalopathy
KW  - Hyponatremia
KW  - Infections
KW  - ACLF
KW  - Quality of life
Y1  - 2020
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/63122
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-631225
SN  - 1600-0641
N1  - The work described has been funded by a H2020 Grant – LIVERHOPE – Project number: 731875.
VL  - 74
IS  - 1
SP  - 200
EP  - 219
PB  - Elsevier Science
CY  - Amsterdam [u.a.]
ER  -