Journal of hepatology · 2020
Endpoints and design of clinical trials in patients with decompensated cirrhosis: Position paper of the LiverHope Consortium.
СтатьяПоддержка исследования: вне правительства СШАConsensus StatementНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Solà Elsa, Pose Elisa, Campion Daniela, Piano Salvatore, Roux Olivier, Simon-Talero Macarena, Uschner Frank, de Wit Koos, Zaccherini Giacomo, Alessandria Carlo, Beuers Ulrich, Caraceni Paolo, Francoz Claire, Mookerjee Rajeshwar P, Trebicka Jonel, Vargas Victor, Serra Miquel, Torres Ferran, Montagnese Sara, Krag Aleksander, Hernaez Ruben, Korenjak Marko, Watson Hugh, Abraldes Juan G, Kamath Patrick S, Ginès Pere, LiverHope Consortium Investigators
Аннотация
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.