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484 results

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Page 1
A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis.
Hirschfield GM, Bowlus CL, Mayo MJ, Kremer AE, Vierling JM, Kowdley KV, Levy C, Villamil A, Ladrón de Guevara Cetina AL, Janczewska E, Zigmond E, Jeong SH, Yilmaz Y, Kallis Y, Corpechot C, Buggisch P, Invernizzi P, Londoño Hurtado MC, Bergheanu S, Yang K, Choi YJ, Crittenden DB, McWherter CA; RESPONSE Study Group. Hirschfield GM, et al. Among authors: kowdley kv. N Engl J Med. 2024 Feb 29;390(9):783-794. doi: 10.1056/NEJMoa2312100. Epub 2024 Feb 21. N Engl J Med. 2024. PMID: 38381664 Clinical Trial.
PRIMIS: design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary sclerosing cholangitis.
Trauner M, Chung C, Sterling K, Liu X, Lu X, Xu J, Tempany-Afdhal C, Goodman ZD, Färkkilä M, Tanaka A, Trivedi P, Kowdley KV, Bowlus CL, Levy C, Myers RP. Trauner M, et al. Among authors: kowdley kv. BMC Gastroenterol. 2023 Mar 15;23(1):75. doi: 10.1186/s12876-023-02653-2. BMC Gastroenterol. 2023. PMID: 36922785 Free PMC article. Clinical Trial.
Optimizing therapy in primary biliary cholangitis: Alkaline phosphatase at six months identifies one-year non-responders and predicts survival.
Murillo Perez CF, Ioannou S, Hassanally I, Trivedi PJ, Corpechot C, van der Meer AJ, Lammers WJ, Battezzati PM, Lindor KD, Nevens F, Kowdley KV, Bruns T, Cazzagon N, Floreani A, Mason AL, Gulamhusein A, Ponsioen CY, Carbone M, Lleo A, Mayo MJ, Dalekos GN, Gatselis NK, Thorburn D, Verhelst X, Parés A, Londoño MC, Janssen HLA, Invernizzi P, Vuppalanchi R, Hirschfield GM, Hansen BE, Levy C; Global PBC Study Group. Murillo Perez CF, et al. Among authors: kowdley kv. Liver Int. 2023 Jul;43(7):1497-1506. doi: 10.1111/liv.15592. Epub 2023 May 8. Liver Int. 2023. PMID: 37157905
Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH.
Loomba R, Sanyal AJ, Kowdley KV, Bhatt DL, Alkhouri N, Frias JP, Bedossa P, Harrison SA, Lazas D, Barish R, Gottwald MD, Feng S, Agollah GD, Hartsfield CL, Mansbach H, Margalit M, Abdelmalek MF. Loomba R, et al. Among authors: kowdley kv. N Engl J Med. 2023 Sep 14;389(11):998-1008. doi: 10.1056/NEJMoa2304286. Epub 2023 Jun 24. N Engl J Med. 2023. PMID: 37356033 Free PMC article. Clinical Trial.
Efficacy and Safety of Elafibranor in Primary Biliary Cholangitis.
Kowdley KV, Bowlus CL, Levy C, Akarca US, Alvares-da-Silva MR, Andreone P, Arrese M, Corpechot C, Francque SM, Heneghan MA, Invernizzi P, Jones D, Kruger FC, Lawitz E, Mayo MJ, Shiffman ML, Swain MG, Valera JM, Vargas V, Vierling JM, Villamil A, Addy C, Dietrich J, Germain JM, Mazain S, Rafailovic D, Taddé B, Miller B, Shu J, Zein CO, Schattenberg JM; ELATIVE Study Investigators’ Group; ELATIVE Study Investigators' Group. Kowdley KV, et al. N Engl J Med. 2024 Feb 29;390(9):795-805. doi: 10.1056/NEJMoa2306185. Epub 2023 Nov 13. N Engl J Med. 2024. PMID: 37962077 Clinical Trial.
A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis.
Harrison SA, Bedossa P, Guy CD, Schattenberg JM, Loomba R, Taub R, Labriola D, Moussa SE, Neff GW, Rinella ME, Anstee QM, Abdelmalek MF, Younossi Z, Baum SJ, Francque S, Charlton MR, Newsome PN, Lanthier N, Schiefke I, Mangia A, Pericàs JM, Patil R, Sanyal AJ, Noureddin M, Bansal MB, Alkhouri N, Castera L, Rudraraju M, Ratziu V; MAESTRO-NASH Investigators. Harrison SA, et al. N Engl J Med. 2024 Feb 8;390(6):497-509. doi: 10.1056/NEJMoa2309000. N Engl J Med. 2024. PMID: 38324483 Clinical Trial.
Primary biliary cholangitis drug evaluation and regulatory approval: Where do we go from here?
Jones DE, Beuers U, Bonder A, Carbone M, Culver E, Dyson J, Gish RG, Hansen BE, Hirschfield G, Jones R, Kowdley K, Kremer AE, Lindor K, Mayo M, Mells G, Neuberger J, Prince M, Swain M, Tanaka A, Thorburn D, Trauner M, Trivedi P, Weltman M, Yeoman A, Levy C. Jones DE, et al. Hepatology. 2024 Mar 22. doi: 10.1097/HEP.0000000000000864. Online ahead of print. Hepatology. 2024. PMID: 38506926
484 results