Pericàs, Juan M;
Anstee, Quentin M;
Augustin, Salvador;
Bataller, Ramón;
Berzigotti, Annalisa;
Ciudin, Andreea;
Francque, Sven;
... Genescà, Joan; + view all
(2024)
A roadmap for clinical trials in MASH-related compensated cirrhosis.
Nature Reviews Gastroenterology and Hepatology
10.1038/s41575-024-00955-8.
(In press).
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Pericas clinical trials in cirrhosis NRGH 2024 submitted.pdf - Accepted Version Access restricted to UCL open access staff until 18 January 2025. Download (1MB) |
Abstract
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.
| Type: | Article |
|---|---|
| Title: | A roadmap for clinical trials in MASH-related compensated cirrhosis |
| Location: | England |
| DOI: | 10.1038/s41575-024-00955-8 |
| Publisher version: | https://doi.org/10.1038/s41575-024-00955-8 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| 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.ucl.ac.uk/id/eprint/10196315 |
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