Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis.

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Title: Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis.
Authors: Sanyal AJ; Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, USA. Electronic address: arun.sanyal@vcuhealth.org., Ratziu V; Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Hôpital Pitié-Salpêtrière, Institute for Cardiometabolism and Nutrition, Paris, France., Loomba R; University of California, San Diego, La Jolla, CA, USA., Anstee QM; Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Framlington Place, Newcastle Upon Tyne, UK; Newcastle NIHR Biomedical Research Center, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK., Kowdley KV; Liver Institute Northwest, Seattle, WA, USA., Rinella ME; University of Chicago, Pritzker School of Medicine, Chicago, IL, USA., Sheikh MY; Fresno Clinical Research Center, Fresno, CA, USA., Trotter JF; Baylor Health, Liver Consultants of Texas, Dallas, TX, USA., Knapple W; Arkansas Gastroenterology, North Little Rock, AR, USA., Lawitz EJ; Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX, USA., Abdelmalek MF; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA., Newsome PN; National Institute for Health Research Birmingham Biomedical Research Centre, Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK., Boursier J; Angers University Hospital, Angers University, Angers, France., Mathurin P; Hepatogastroenterology, CHU Lille, Lille, France., Dufour JF; Center for Digestive Diseases, Lausanne, Switzerland., Berrey MM; Intercept Pharmaceuticals, Morristown, NJ, USA., Shiff SJ; Intercept Pharmaceuticals, Morristown, NJ, USA., Sawhney S; Intercept Pharmaceuticals, Morristown, NJ, USA., Capozza T; Intercept Pharmaceuticals, Morristown, NJ, USA., Leyva R; Intercept Pharmaceuticals, Morristown, NJ, USA., Harrison SA; Pinnacle Clinical Research Center, San Antonio, TX, USA., Younossi ZM; Beatty Liver and Obesity Research Program, Center for Liver Diseases, Inova Medicine, Falls Church, VA, USA.
Source: Journal of hepatology [J Hepatol] 2023 Nov; Vol. 79 (5), pp. 1110-1120. Date of Electronic Publication: 2023 Jul 28.
Publication Type: Journal Article; Clinical Trial, Phase III; Randomized Controlled Trial
Journal Info: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8503886 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1600-0641 (Electronic) Linking ISSN: 01688278 NLM ISO Abbreviation: J Hepatol Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis.
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  Data: <searchLink fieldCode="AU" term="%22Sanyal+AJ%22">Sanyal AJ</searchLink>; Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, USA. Electronic address: arun.sanyal@vcuhealth.org.<br /><searchLink fieldCode="AU" term="%22Ratziu+V%22">Ratziu V</searchLink>; Sorbonne Université, Assistance Publique-Hôpitaux de Paris, Hôpital Pitié-Salpêtrière, Institute for Cardiometabolism and Nutrition, Paris, France.<br /><searchLink fieldCode="AU" term="%22Loomba+R%22">Loomba R</searchLink>; University of California, San Diego, La Jolla, CA, USA.<br /><searchLink fieldCode="AU" term="%22Anstee+QM%22">Anstee QM</searchLink>; Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Framlington Place, Newcastle Upon Tyne, UK; Newcastle NIHR Biomedical Research Center, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.<br /><searchLink fieldCode="AU" term="%22Kowdley+KV%22">Kowdley KV</searchLink>; Liver Institute Northwest, Seattle, WA, USA.<br /><searchLink fieldCode="AU" term="%22Rinella+ME%22">Rinella ME</searchLink>; University of Chicago, Pritzker School of Medicine, Chicago, IL, USA.<br /><searchLink fieldCode="AU" term="%22Sheikh+MY%22">Sheikh MY</searchLink>; Fresno Clinical Research Center, Fresno, CA, USA.<br /><searchLink fieldCode="AU" term="%22Trotter+JF%22">Trotter JF</searchLink>; Baylor Health, Liver Consultants of Texas, Dallas, TX, USA.<br /><searchLink fieldCode="AU" term="%22Knapple+W%22">Knapple W</searchLink>; Arkansas Gastroenterology, North Little Rock, AR, USA.<br /><searchLink fieldCode="AU" term="%22Lawitz+EJ%22">Lawitz EJ</searchLink>; Texas Liver Institute, University of Texas Health San Antonio, San Antonio, TX, USA.<br /><searchLink fieldCode="AU" term="%22Abdelmalek+MF%22">Abdelmalek MF</searchLink>; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.<br /><searchLink fieldCode="AU" term="%22Newsome+PN%22">Newsome PN</searchLink>; National Institute for Health Research Birmingham Biomedical Research Centre, Centre for Liver and Gastrointestinal Research, Institute of Immunology and Immunotherapy, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK.<br /><searchLink fieldCode="AU" term="%22Boursier+J%22">Boursier J</searchLink>; Angers University Hospital, Angers University, Angers, France.<br /><searchLink fieldCode="AU" term="%22Mathurin+P%22">Mathurin P</searchLink>; Hepatogastroenterology, CHU Lille, Lille, France.<br /><searchLink fieldCode="AU" term="%22Dufour+JF%22">Dufour JF</searchLink>; Center for Digestive Diseases, Lausanne, Switzerland.<br /><searchLink fieldCode="AU" term="%22Berrey+MM%22">Berrey MM</searchLink>; Intercept Pharmaceuticals, Morristown, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Shiff+SJ%22">Shiff SJ</searchLink>; Intercept Pharmaceuticals, Morristown, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Sawhney+S%22">Sawhney S</searchLink>; Intercept Pharmaceuticals, Morristown, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Capozza+T%22">Capozza T</searchLink>; Intercept Pharmaceuticals, Morristown, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Leyva+R%22">Leyva R</searchLink>; Intercept Pharmaceuticals, Morristown, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Harrison+SA%22">Harrison SA</searchLink>; Pinnacle Clinical Research Center, San Antonio, TX, USA.<br /><searchLink fieldCode="AU" term="%22Younossi+ZM%22">Younossi ZM</searchLink>; Beatty Liver and Obesity Research Program, Center for Liver Diseases, Inova Medicine, Falls Church, VA, USA.
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  Data: <searchLink fieldCode="JN" term="%228503886%22">Journal of hepatology</searchLink> [J Hepatol] 2023 Nov; Vol. 79 (5), pp. 1110-1120. <i>Date of Electronic Publication: </i>2023 Jul 28.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier%22">Elsevier </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>8503886 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1600-0641 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2201688278%22">01688278 </searchLink><i>NLM ISO Abbreviation: </i>J Hepatol <i>Subsets: </i>MEDLINE
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