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Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial

Authors :
Younossi, Zobair M
Ratziu, Vlad
Loomba, Rohit
Rinella, Mary
Anstee, Quentin M
Goodman, Zachary
Bedossa, Pierre
Geier, Andreas
Beckebaum, Susanne
Newsome, Philip N
Sheridan, David
Sheikh, Muhammad Y
Trotter, James
Knapple, Whitfield
Lawitz, Eric
Abdelmalek, Manal F
Kowdley, Kris V
Montano-Loza, Aldo J
Boursier, Jerome
Mathurin, Philippe
Bugianesi, Elisabetta
Mazzella, Giuseppe
Olveira, Antonio
Cortez-Pinto, Helena
Graupera, Isabel
Orr, David
Gluud, Lise Lotte
Dufour, Jean-Francois
Shapiro, David
Campagna, Jason
Zaru, Luna
MacConell, Leigh
Shringarpure, Reshma
Harrison, Stephen
Sanyal, Arun J
Abdelmalek, Manal
Abrams, Gary
Aguilar, Humberto
Ahmed, Aijaz
Aigner, Elmar
Aithal, Guruprasad
Ala, Aftab
Alazawi, William
Albillos, Agustin
Allison, Michael
Al-Shamma, Sfa
Andrade, Raul
Andreone, Pietro
Angelico, Mario
Ankoma-Sey, Victor
Anstee, Quentin
Anty, Rodolphe
Araya, Victor
Arenas Ruiz, Juan Ignacio
Arkkila, Perttu
Arora, Marty
Asselah, Tarik
Au, Jennifer
Ayonrinde, Oyekoya
Bailey, Robert James
Balakrishnan, Maya
Bambha, Kiran
Bansal, Meena
Barritt, Sidney
Bate, John
Beato, Jorge
Beckebaum, Susanne
Behari, Jaideep
Bellot, Pablo
Ben Ari, Ziv
Bennett, Michael
Berenguer, Marina
Beretta-Piccoli, Benedetta Terziroli
Berg, Thomas
Bonacini, Maurizio
Bonet, Lucia
Borg, Brian
Bourliere, Marc
Boursier, Jerome
Bowman, William
Bradley, David
Brankovic, Marija
Braun, Marius
Bronowicki, Jean-Pierre
Bruno, Savino
Bugianesi, Elisabetta
Cai, Cindy
Calderon, Amy
Calleja Panero, José Luis
Carey, Elizabeth
Carmiel, Michal
Carrión, Jose Antonio
Cave, Matthew
Chagas, Cristina
Chami, Tawfik
Chang, Alan
Coates, Allan
Cobbold, Jeremy
Costentin, Charlote
Corey, Kathleen
Corless, Lynsey
Cortez-Pinto, Helena
Crespo, Javier
Cruz Pereira, Oscar
de Ledinghen, Victor
deLemos, Andrew
Diago, Moises
Dong, Mamie
Dufour, Jean-François
Dugalic, Predrag
Dunn, Winston
Elkhashab, Magby
Epstein, Michael
Escudero-Garcia, Maria Desamparados
Etzion, Ohad
Evans, Larry
Falcone, Robert
Fernandez, Conrado
Ferreira, Jose
Fink, Scott
Finnegan, Kevin
Firpi-Morell, Roberto
Floreani, Annarosa
Fontanges, Thierry
Ford, Ryan
Forrest, Ewan
Fowell, Andrew
Fracanzani, Anna Ludovica
Francque, Sven
Freilich, Bradley
Frias, Juan
Fuchs, Michael
Fuentes, Javier
Galambos, Michael
Gallegos, Juan
Geerts, Anja
Geier, Andreas
George, Jacob
Ghali, Maged
Ghalib, Reem
Gholam, Pierre
Gines, Pere
Gitlin, Norman
Gluud, Lise Lotte
Goeser, Tobias
Goff, John
Gordon, Stuart
Gordon, Frederic
Goria, Odile
Greer, Shaun
Grigorian, Alla
Gronbaek, Henning
Guillaume, Maeva
Gunaratnam, Naresh
Halegoua-De Marzio, Dina
Hameed, Bilal
Hametner, Stephanie
Hamilton, James
Harrison, Stephen
Hartleb, Marek
Hassanein, Tarek
Häussinger, Dieter
Hellstern, Paul
Herring, Robert
Heurich, Eva
Hezode, Christophe
Hinrichsen, Holger
Holland Fischer, Peter
Horsmans, Yves
Huang, Jonathan
Hussaini, Hyder
Jakiche, Antoine
Jeffers, Lennox
Jones, Blake
Jorge, Rosa
Jorquera, Francisco
Joshi, Shoba
Kahraman, Alisan
Kaita, Kelly
Karyotakis, Nicholas
Kayali, Zeid
Kechagias, Stergios
Kepczyk, Thomas
Khalili, Mandana
Khallafi, Hicham
Kluwe, Johannes
Knapple, Whitfield
Kohli, Anita
Korenblat, Kevin
Kowdley, Kris
Krag, Aleksander
Krause, Richard
Kremer, Andreas
Krok, Karen
Krstic, Miodrag
Kugelmas, Marcelo
Kumar, Sonal
Kuwada, Scott
Labarriere, Damien
Lai, Michelle
Laleman, Wim
Lampertico, Pietro
Lawitz, Eric
Lee, Alice
Leroy, Vincent
Lidofsky, Steven
Lim, Tina Huey
Lim, Joseph
Lipkis, Donald
Little, Ester
Lonardo, Amadeo
Long, Michelle
Loomba, Rohit
Luketic, Velimir Anthony Christopher
Lurie, Yoav
Macedo, Guilherme
Magalhaes, Joana
Makara, Mihály
Maliakkal, Benedict
Manns, Michael
Manousou, Pinelopi
Mantry, Parvez
Marchesini, Giulio
Marinho, Carla
Marotta, Paul
Marschall, Hanns-Ulrich
Martinez, Linda
Mathurin, Philippe
Mayo, Marlyn
Mazzella, Giuseppe
McCullen, Mark
McLaughlin, William
Merle, Uta
Merriman, Raphael
Modi, Apurva
Molina, Esther
Montano-Loza, Aldo
Monteverde, Carlos
Morales Cardona, Amilcar
Moreea, Sulleman
Moreno, Christophe
Morisco, Filomena
Mubarak, Abdullah
Muellhaupt, Beat
Mukherjee, Sandeep
Müller, Tobias
Nagorni, Aleksandar
Naik, Jahnavi
Neff, Guy
Nevah, Moises
Newsome, Philip
Nguyen-Khac, Eric
Noureddin, Mazen
Oben, Jude
Olveira, Antonio
Orlent, Hans
Orr, David
Orr, James
Ortiz-Lasanta, Grisell
Ozenne, Violaine
Pandya, Prashant
Paredes, Angelo
Park, James
Patel, Joykumar
Patel, Keyur
Paul, Sonali
Patton, Heather
Peck-Radosavljevic, Markus
Petta, Salvatore
Pianko, Stephen
Piekarska, Anna
Pimstone, Neville
Pisegna, Joseph
Pockros, Paul
Pol, Stanislas
Porayko, Michael
Poulos, John
Pound, David
Pouzar, Joe
Presa Ramos, Jose
Pyrsopoulos, Nikolaos
Rafiq, Nila
Muller, Kate
Ramji, Alnoor
Ratziu, Vlad
Ravinuthala, Ravi
Reddy, Chakradhar
Reddy K G, Gautham
Reddy K R, K. Rajender
Regenstein, Frederic
Reindollar, Robert
Reynolds, Justin
Riera, Andres
Rinella, Mary
Rivera Acosta, Jose
Robaeys, Geert
Roberts, Stuart
Rodriguez-Perez, Federico
Romero, Sandor
Romero-Gomez, Manuel
Rubin, Raymond
Rumi, Mariagrazia
Rushbrook, Simon
Rust, Christian
Ryan, Michael
Safadi, Rifaat
Said, Adnan
Salminen, Kimmo
Samuel, Didier
Santoro, John
Sanyal, Arun
Sarkar, Souvik
Schaeffer, Cynthia
Schattenberg, Jörn
Schiefke, Ingolf
Schiff, Eugene
Schmidt, Wolfgang
Schneider, Jeffrey
Schouten, Jeoffrey
Schultz, Michael
Sebastiani, Giada
Semela, David
Sepe, Thomas
Sheikh, Aasim
Sheikh, Muhammad
Sheridan, David
Sherman, Kenneth
Shibolet, Oren
Shiffman, Mitchell
Siddique, Asma
Sieberhagen, Cyril
Sigal, Samuel
Sikorska, Katarzyna
Simon, Krzysztof
Sinclair, Marie
Skoien, Richard
Solis, Joel
Sood, Siddharth
Souder, Bob
Spivey, James
Stal, Per
Stinton, Laura
Strasser, Simone
Svorcan, Petar
Szabo, Gyongzi
Talal, Andrew
Tam, Edward
Tetri, Brent
Thuluvath, Paul
Tobias, Hillel
Tomasiewicz, Krzysztof
Torres, Dawn
Tran, Albert
Trauner, Michael
Trautwein, Christian
Trotter, James
Tsochatzis, Emanuel
Unitt, Esther
Vargas, Victor
Varkonyi, Istvan
Veitsman, Ella
Vespasiani Gentilucci, Umberto
Victor, David
Vierling, John
Vincent, Catherine
Vincze, Aron
von der Ohe, Manfred
Von Roenn, Natasha
Vuppalanchi, Raj
Waters, Michael
Watt, Kymberly
Wattacheril, Julia
Weltman, Martin
Wieland, Amanda
Wiener, Gregory
Williams A, Alonzo
Williams J, Jeffrey
Wilson, Jason
Yataco, Maria
Yoshida, Eric
Younes, Ziad
Yuan, Liyun
Zivony, Adam
Zogg, Donald
Zoller, Heinz
Zoulim, Fabien
Zuckerman, Eli
Zuin, Massimo
Source :
The Lancet; December 2019, Vol. 394 Issue: 10215 p2184-2196, 13p
Publication Year :
2019

Abstract

Non-alcoholic steatohepatitis (NASH) is a common type of chronic liver disease that can lead to cirrhosis. Obeticholic acid, a farnesoid X receptor agonist, has been shown to improve the histological features of NASH. Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH.

Details

Language :
English
ISSN :
01406736 and 1474547X
Volume :
394
Issue :
10215
Database :
Supplemental Index
Journal :
The Lancet
Publication Type :
Periodical
Accession number :
ejs51716304
Full Text :
https://doi.org/10.1016/S0140-6736(19)33041-7