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Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial.

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Title: Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial.
Authors: Trauner M; Division of Gastroenterology and Hepatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria. Electronic address: michael.trauner@meduniwien.ac.at., Levy C; Division of Digestive Health and Liver Diseases and Schiff Center for Liver Diseases, University of Miami Miller School of Medicine, Miami, FL, USA., Tanaka A; Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan., Goodman Z; Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA., Thorburn D; The Sheila Sherlock Liver Centre and UCL Institute of Liver and Digestive Health, Royal Free Hospital, London, UK., Joshi D; Institute of Liver Studies, King's College Hospital NHS Foundation Trust, London, UK., Salminen K; Division of Gastroenterology, Department of Medicine, Turku University Hospital, Turku, Finland., Yimam K; Department of Hepatology and Liver Transplantation, California Pacific Medical Center, San Francisco, CA, USA., Isayama H; Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan., Montano-Loza AJ; Division of Gastroenterology and Liver Unit, University of Alberta, Edmonton, AB, Canada., Caldwell S; Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA, USA., Danta M; School of Clinical Medicine, Faculty of Medicine, UNSW, Sydney, Australia; Department of Gastroenterology and Hepatology, St Vincent's Hospital, Sydney, NSW, Australia., Farkkila M; Clinic of Gastroenterology, Helsinki University, Helsinki University Hospital, Helsinki, Finland., Gallegos-Orozco JF; Division of Gastroenterology and Hepatology, University of Utah Spencer Fox Eccles School of Medicine, Salt Lake City, UT, USA., Gordon SC; Department of Gastroenterology and Hepatology, Henry Ford Hospital, Detroit, MI, USA; Wayne State University School of Medicine, Detroit, MI, USA., Hinrichsen H; Gastroenterologisch-Hepatologisches MVZ Kiel, Kiel, Germany., Invernizzi P; Division of Gastroenterology, Center for Autoimmune Liver Diseases, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), IRCCS Fondazione San Gerardo dei Tintori, Monza, Italy; Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy., Vuppalanchi R; Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, IN, USA., Zhu K; Gilead Sciences, Foster City, CA, USA., Xu J; Gilead Sciences, Foster City, CA, USA., Liu X; Gilead Sciences, Foster City, CA, USA., Lu X; Gilead Sciences, Foster City, CA, USA., Crans G; Gilead Sciences, Foster City, CA, USA., Bolbolan S; Gilead Sciences, Foster City, CA, USA., Boyette L; Gilead Sciences, Foster City, CA, USA., Alani M; Gilead Sciences, Foster City, CA, USA., Barchuk WT; Gilead Sciences, Foster City, CA, USA., Watkins TR; Gilead Sciences, Foster City, CA, USA., Genovese MC; Gilead Sciences, Foster City, CA, USA., Bowlus CL; Division of Gastroenterology and Hepatology, University of California Davis School of Medicine, Sacramento, CA, USA.
Source: The lancet. Gastroenterology & hepatology [Lancet Gastroenterol Hepatol] 2026 Jan; Vol. 11 (1), pp. 46-58. Date of Electronic Publication: 2025 Oct 28.
Publication Type: Journal Article; Clinical Trial, Phase III; Randomized Controlled Trial; Multicenter Study
Journal Info: Publisher: Elsevier B.V Country of Publication: Netherlands NLM ID: 101690683 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2468-1253 (Electronic) NLM ISO Abbreviation: Lancet Gastroenterol Hepatol Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial.
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  Data: <searchLink fieldCode="AU" term="%22Trauner+M%22">Trauner M</searchLink>; Division of Gastroenterology and Hepatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria. Electronic address: michael.trauner@meduniwien.ac.at.<br /><searchLink fieldCode="AU" term="%22Levy+C%22">Levy C</searchLink>; Division of Digestive Health and Liver Diseases and Schiff Center for Liver Diseases, University of Miami Miller School of Medicine, Miami, FL, USA.<br /><searchLink fieldCode="AU" term="%22Tanaka+A%22">Tanaka A</searchLink>; Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Goodman+Z%22">Goodman Z</searchLink>; Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.<br /><searchLink fieldCode="AU" term="%22Thorburn+D%22">Thorburn D</searchLink>; The Sheila Sherlock Liver Centre and UCL Institute of Liver and Digestive Health, Royal Free Hospital, London, UK.<br /><searchLink fieldCode="AU" term="%22Joshi+D%22">Joshi D</searchLink>; Institute of Liver Studies, King's College Hospital NHS Foundation Trust, London, UK.<br /><searchLink fieldCode="AU" term="%22Salminen+K%22">Salminen K</searchLink>; Division of Gastroenterology, Department of Medicine, Turku University Hospital, Turku, Finland.<br /><searchLink fieldCode="AU" term="%22Yimam+K%22">Yimam K</searchLink>; Department of Hepatology and Liver Transplantation, California Pacific Medical Center, San Francisco, CA, USA.<br /><searchLink fieldCode="AU" term="%22Isayama+H%22">Isayama H</searchLink>; Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Montano-Loza+AJ%22">Montano-Loza AJ</searchLink>; Division of Gastroenterology and Liver Unit, University of Alberta, Edmonton, AB, Canada.<br /><searchLink fieldCode="AU" term="%22Caldwell+S%22">Caldwell S</searchLink>; Division of Gastroenterology and Hepatology, University of Virginia Health System, Charlottesville, VA, USA.<br /><searchLink fieldCode="AU" term="%22Danta+M%22">Danta M</searchLink>; School of Clinical Medicine, Faculty of Medicine, UNSW, Sydney, Australia; Department of Gastroenterology and Hepatology, St Vincent's Hospital, Sydney, NSW, Australia.<br /><searchLink fieldCode="AU" term="%22Farkkila+M%22">Farkkila M</searchLink>; Clinic of Gastroenterology, Helsinki University, Helsinki University Hospital, Helsinki, Finland.<br /><searchLink fieldCode="AU" term="%22Gallegos-Orozco+JF%22">Gallegos-Orozco JF</searchLink>; Division of Gastroenterology and Hepatology, University of Utah Spencer Fox Eccles School of Medicine, Salt Lake City, UT, USA.<br /><searchLink fieldCode="AU" term="%22Gordon+SC%22">Gordon SC</searchLink>; Department of Gastroenterology and Hepatology, Henry Ford Hospital, Detroit, MI, USA; Wayne State University School of Medicine, Detroit, MI, USA.<br /><searchLink fieldCode="AU" term="%22Hinrichsen+H%22">Hinrichsen H</searchLink>; Gastroenterologisch-Hepatologisches MVZ Kiel, Kiel, Germany.<br /><searchLink fieldCode="AU" term="%22Invernizzi+P%22">Invernizzi P</searchLink>; Division of Gastroenterology, Center for Autoimmune Liver Diseases, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), IRCCS Fondazione San Gerardo dei Tintori, Monza, Italy; Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.<br /><searchLink fieldCode="AU" term="%22Vuppalanchi+R%22">Vuppalanchi R</searchLink>; Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, IN, USA.<br /><searchLink fieldCode="AU" term="%22Zhu+K%22">Zhu K</searchLink>; Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Xu+J%22">Xu J</searchLink>; Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Liu+X%22">Liu X</searchLink>; Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Lu+X%22">Lu X</searchLink>; Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Crans+G%22">Crans G</searchLink>; Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Bolbolan+S%22">Bolbolan S</searchLink>; Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Boyette+L%22">Boyette L</searchLink>; Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Alani+M%22">Alani M</searchLink>; Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Barchuk+WT%22">Barchuk WT</searchLink>; Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Watkins+TR%22">Watkins TR</searchLink>; Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Genovese+MC%22">Genovese MC</searchLink>; Gilead Sciences, Foster City, CA, USA.<br /><searchLink fieldCode="AU" term="%22Bowlus+CL%22">Bowlus CL</searchLink>; Division of Gastroenterology and Hepatology, University of California Davis School of Medicine, Sacramento, CA, USA.
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  Data: <searchLink fieldCode="JN" term="%22101690683%22">The lancet. Gastroenterology & hepatology</searchLink> [Lancet Gastroenterol Hepatol] 2026 Jan; Vol. 11 (1), pp. 46-58. <i>Date of Electronic Publication: </i>2025 Oct 28.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+B%2EV%22">Elsevier B.V </searchLink><i>Country of Publication: </i>Netherlands <i>NLM ID: </i>101690683 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2468-1253 (Electronic) <i>NLM ISO Abbreviation: </i>Lancet Gastroenterol Hepatol <i>Subsets: </i>MEDLINE
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