Regenerate: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Multicenter Study of Obeticholic Acid Therapy for Nonalcoholic Steatohepatitis

被引：1
|
作者：
Younossi, Zobair M. [1 ]
Ratziu, Vlad [2 ]
Sanyal, Arun J. [3 ]
MacConell, Leigh [4 ]
Shringarpure, Reshma [4 ]
Marmon, Tonya [4 ]
Shaprio, David [4 ]
机构：
[1] Inova Hlth Syst, Betty & Guy Beatty Ctr Integrated Res, Falls Church, VA USA
[2] Hop La Pitie Salpetriere, Dept Gastroenterol & Hepatol, Paris, France
[3] Virginia Commonwealth Univ, Richmond, VA USA
[4] Intercept Pharmaceut Inc, San Diego, CA USA
来源：
AMERICAN JOURNAL OF GASTROENTEROLOGY | 2016年 / 111卷
关键词：
D O I：
10.14309/00000434-201610001-02502
中图分类号：
R57 [消化系及腹部疾病];
学科分类号：
摘要：
2502
引用
收藏
页码：S1273 / S1273
页数：1
相关论文
共 50 条
  • [1] REGENERATE: A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY OF OBETICHOLIC ACID THERAPY FOR NONALCOHOLIC STEATOHEPATITIS
    Ratziu, V.
    Sanyal, A. J.
    MacConell, L.
    Shringarpure, R.
    Marmon, T.
    Shapiro, D.
    Younossi, Z. M.
    [J]. JOURNAL OF HEPATOLOGY, 2016, 64 : S294 - S295
  • [2] Licogliflozin for nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a study
    Stephen A. Harrison
    Federico Perez Manghi
    William B. Smith
    Diana Alpenidze
    Diego Aizenberg
    Naomi Klarenbeek
    Chi-Yi Chen
    Eli Zuckerman
    Eric Ravussin
    Phunchai Charatcharoenwitthaya
    Pin-Nan Cheng
    Helena Katchman
    Samuel Klein
    Ziv Ben-Ari
    Anisha E. Mendonza
    Yiming Zhang
    Miljen Martic
    Shenglin Ma
    Sheena Kao
    Sandra Tanner
    Alok Pachori
    Michael K. Badman
    YanLing He
    Chinweike Ukomadu
    Eric Sicard
    [J]. Nature Medicine, 2022, 28 : 1432 - 1438
  • [3] Licogliflozin for nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a study
    Harrison, Stephen A.
    Manghi, Federico Perez
    Smith, William B.
    Alpenidze, Diana
    Aizenberg, Diego
    Klarenbeek, Naomi
    Chen, Chi-Yi
    Zuckerman, Eli
    Ravussin, Eric
    Charatcharoenwitthaya, Phunchai
    Cheng, Pin-Nan
    Katchman, Helena
    Klein, Samuel
    Ben-Ari, Ziv
    Mendonza, Anisha E.
    Zhang, Yiming
    Martic, Miljen
    Ma, Shenglin
    Kao, Sheena
    Tanner, Sandra
    Pachori, Alok
    Badman, Michael K.
    He, YanLing
    Ukomadu, Chinweike
    Sicard, Eric
    [J]. NATURE MEDICINE, 2022, 28 (07) : 1432 - +
  • [4] Control: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Investigating the Effects of Obeticholic Acid and Atorvastatin Treatment on Lipoprotein Metabolism in Patients with Nonalcoholic Steatohepatitis
    Pockros, Paul J.
    Fuchs, Michael
    Freilich, Bradley L.
    Schiff, Eugene R.
    Kohli, Anita
    Lawitz, Eric J.
    Hellstern, Paul A.
    Cohen, David E.
    Owens-Grillo, Janet
    Van Biene, Courtney
    Shringarpure, Reshma
    MacConell, Leigh
    Shapiro, David A.
    [J]. HEPATOLOGY, 2018, 68 : 951A - 952A
  • [5] REGENERATE: A Global Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of OCA for NASH
    Ratziu, Vlad
    Sanyal, Arun J.
    MacConell, Leigh
    Herrmann, Sibylle
    Shringarpure, Reshma
    Marmon, Tonya
    Shapiro, David
    Younossi, Zobair M.
    [J]. SWISS MEDICAL WEEKLY, 2016, 146 : 17S - 17S
  • [6] High-Dose Ursodeoxycholic Acid Therapy for Nonalcoholic Steatohepatitis: A Double-Blind, Randomized, Placebo-Controlled Trial
    Leuschner, Ulrich F. H.
    Lindenthal, Birgit
    Herrmann, Guenter
    Arnold, Joachim C.
    Roessle, Martin
    Cordes, Hans-Joerg
    Zeuzem, Stefan
    Hein, Jasper
    Berg, Thomas
    [J]. HEPATOLOGY, 2010, 52 (02) : 472 - 479
  • [7] A phase 2, randomized, double-blind, placebo-controlled study of GS-9450 in subjects with nonalcoholic steatohepatitis
    Ratziu, Vlad
    Sheikh, Muhammad Y.
    Sanyal, Arun J.
    Lim, Joseph K.
    Conjeevaram, Hari
    Chalasani, Naga
    Abdelmalek, Manal
    Bakken, Anezi
    Renou, Christophe
    Palmer, Melissa
    Levine, Robert A.
    Bhandari, B. Raj
    Cornpropst, Melanie
    Liang, Wei
    King, Benjamin
    Mondou, Elsa
    Rousseau, Franck S.
    McHutchison, John
    Chojkier, Mario
    [J]. HEPATOLOGY, 2012, 55 (02) : 419 - 428
  • [8] VITAMIN E (300mg) VERSUS PLACEBO IN THE TREATMENT OF NONALCOHOLIC STEATOHEPATITIS: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
    Harrison, Stephen A.
    Tomah, Shaheen
    Suschak, John J.
    Kasper, Jonathan
    Roberts, M. Scot
    Harris, M. Scott
    Browne, Sarah K.
    [J]. HEPATOLOGY, 2024, 79 (02) : E53 - E54
  • [9] Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial
    V. Ratziu
    L. de Guevara
    R. Safadi
    F. Poordad
    F. Fuster
    J. Flores-Figueroa
    M. Arrese
    Anna L. Fracanzani
    D. Ben Bashat
    K. Lackner
    T. Gorfine
    S. Kadosh
    R. Oren
    M. Halperin
    L. Hayardeny
    R. Loomba
    S. Friedman
    Arun J. Sanyal
    [J]. Nature Medicine, 2021, 27 : 1825 - 1835
  • [10] Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial
    Ratziu, V.
    de Guevara, L.
    Safadi, R.
    Poordad, F.
    Fuster, F.
    Flores-Figueroa, J.
    Arrese, M.
    Fracanzani, Anna L.
    Ben Bashat, D.
    Lackner, K.
    Gorfine, T.
    Kadosh, S.
    Oren, R.
    Halperin, M.
    Hayardeny, L.
    Loomba, R.
    Friedman, S.
    Sanyal, Arun J.
    [J]. NATURE MEDICINE, 2021, 27 (10) : 1825 - +
12345