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New position paper on the design of clinical trials in patients with decompensated cirrhosis

Friday, 15 January, 2021

This guide has been carried out within the LiverHope Consortium, founded by the European Commission under the Horizon 2020 program.

The design of clinical trials in patients with decompensated cirrhosis is quite complex, as these patients often have comorbidities and the origin of the disease may differ depending on the patient. LiverHope has brought together experts from different institutions to launch a document with recommendations for the design of these clinical trials. Two members of the Hepatology Service of Vall d’Hebron Hospital, Dr. Macarena Simón Talero, assistant doctor, and Dr. Víctor Vargas, senior teaching consultant and professor of Medicine at the Autonomous University of Barcelona, ​​has participated in the preparation of this position document that has been published in the prestigious Journal of Hepatology. Both professionals are part of LiverHope, a consortium of nine European hospitals from seven different countries with extensive experience in hepatology (Vall d’Hebron, Hospital Clínic, Padua University Hospital, Città della Salute e della Scienza in Turin, Beaujon Hospital, Hospital Goethe University Frankfurt, Academic Medical Center in Amsterdam, Alma Mater Studiorum at the University of Bologna and University College of London). The aim of this consortium is to study new treatments for cirrhosis.

The LiverHope consortium’s position paper, which is part of the European Commission’s Horizon 2020 program, is the result of a two-day meeting in groups of two researchers (one senior and one junior) who are members of the consortium. The young researchers in each group summarized all the data from each of the possible situations that cirrhotic patients may encounter, and then agreed with the senior researchers and wrote the paper. "On the one hand, the concepts for the design of clinical trials for cirrhotic patients in general were defined", explains Dr. Víctor Vargas, “and then for each of the specific complications of cirrhosis: ascites, hyponatremia, hepatorenal syndrome, bacterial infections, hepatic and acute encephalopathy where chronic liver failure, in addition to the quality of life in relation to health”.

Until now there was not such a complete document that brought together all the situations of patients with cirrhosis. Now, with this guide, all aspects of decompensated cirrhotic patients have been unified globally, thanks to a more accurate trial design. In the future, researchers will be able to draw better conclusions from clinical trials of this disease.

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