Pericàs, Juan M; Anstee, Quentin M; Augustin, Salvador; Bataller, Ramón; Berzigotti, Annalisa; Ciudin, Andreea; Francque, Sven; Abraldes, Juan G; Hernández-Gea, Virginia; Pons, Mònica; Reiberger, Thomas; Rowe, Ian A; Rydqvist, Peter; Schabel, Elmer; Tacke, Frank; Tsochatzis, Emmanuel A; Genescà, Joan (2024). A roadmap for clinical trials in MASH-related compensated cirrhosis. (In Press). Nature reviews Springer Nature 10.1038/s41575-024-00955-8
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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.
Item Type: |
Journal Article (Review Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine > Hepatology 04 Faculty of Medicine > Department of Gastro-intestinal, Liver and Lung Disorders (DMLL) > Clinic of Visceral Surgery and Medicine |
UniBE Contributor: |
Berzigotti, Annalisa |
Subjects: |
600 Technology > 610 Medicine & health 300 Social sciences, sociology & anthropology > 360 Social problems & social services |
ISSN: |
1759-5053 |
Publisher: |
Springer Nature |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
18 Jul 2024 13:36 |
Last Modified: |
19 Jul 2024 07:01 |
Publisher DOI: |
10.1038/s41575-024-00955-8 |
PubMed ID: |
39020089 |
BORIS DOI: |
10.48350/199083 |
URI: |
https://boris.unibe.ch/id/eprint/199083 |
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