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Lookup NU author(s): Professor Quentin AnsteeORCiD
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© Springer Nature Limited 2024.Although metabolic dysfunction-associated steatohepatitis (MASH) is rapidly becoming a leading cause of cirrhosis worldwide, therapeutic options are limited and the number of clinical trials in MASH-related compensated cirrhosis is low as compared to those conducted in earlier disease stages. Moreover, designing clinical trials in MASH cirrhosis presents a series of challenges regarding the understanding and conceptualization of the natural history, regulatory considerations, inclusion criteria, recruitment, end points and trial duration, among others. The first international workshop on the state of the art and future direction of clinical trials in MASH-related compensated cirrhosis was held in April 2023 at Vall d’Hebron University Hospital in Barcelona (Spain) and was attended by a group of international experts on clinical trials from academia, regulatory agencies and industry, encompassing expertise in MASH, cirrhosis, portal hypertension, and regulatory affairs. The presented Roadmap summarizes important content of the workshop on current status, regulatory requirements and end points in MASH-related compensated cirrhosis clinical trials, exploring alternative study designs and highlighting the challenges that should be considered for upcoming studies on MASH cirrhosis.
Author(s): Pericàs JM, Anstee QM, Augustin S, Bataller R, Berzigotti A, Ciudin A, Francque S, Abraldes JG, Hernández-Gea V, Pons M, Reiberger T, Rowe IA, Rydqvist P, Schabel E, Tacke F, Tsochatzis EA, Genescà J
Publication type: Article
Publication status: Published
Journal: Nature Reviews Gastroenterology and Hepatology
Year: 2024
Volume: 21
Pages: 809–823
Online publication date: 17/07/2024
Acceptance date: 03/06/2024
ISSN (print): 1759-5045
ISSN (electronic): 1759-5053
Publisher: Nature Research
URL: https://doi.org/10.1038/s41575-024-00955-8
DOI: 10.1038/s41575-024-00955-8
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