Solà, E;
Pose, E;
Campion, D;
Piano, S;
Roux, O;
Simon-Talero, M;
Uschner, F;
... LiverHope Consortium Investigators; + view all
(2020)
Endpoints and design of clinical trials in patients with decompensated cirrhosis: Position paper of the LiverHope Consortium.
Journal of Hepatology
10.1016/j.jhep.2020.08.009.
(In press).
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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 that can be used for 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, severity of the disease), 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 endpoints. This leads to difficulties in comparing of results obtained from different trials. Against this background, the LiverHope Consortium organized a meeting of experts with the goal of making recommendations for the design of clinical trials and defining appropriate endpoints both for trials aimed at modifying the natural history and preventing progression of decompensated cirrhosis and trials aimed at investigating new therapies for the management of each complication of cirrhosis.
| Type: | Article |
|---|---|
| Title: | Endpoints and design of clinical trials in patients with decompensated cirrhosis: Position paper of the LiverHope Consortium |
| Location: | Netherlands |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1016/j.jhep.2020.08.009 |
| Publisher version: | http://dx.doi.org/10.1016/j.jhep.2020.08.009 |
| Language: | English |
| Additional information: | This article is published under a Creative Commons license (https://creativecommons.org/licenses/by-nc-nd/4.0/) |
| Keywords: | ACLF, AKI, ascites, cirrhosis, clinical trials, endpoints, hepatic encephalopathy, hyponatremia, infections, liver transplant, quality of life |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inst for Liver and Digestive Hlth |
| URI: | https://discovery-pp.ucl.ac.uk/id/eprint/10115849 |
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