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Cenicriviroc for the treatment of liver fibrosis in adults with nonalcoholic steatohepatitis: AURORA Phase 3 study design

Lookup NU author(s): Professor Quentin Anstee

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2019. Introduction: Nonalcoholic steatohepatitis (NASH) is a sub-classification of nonalcoholic fatty liver disease (NAFLD) characterized by increased risk of progressive liver fibrosis. Cenicriviroc (CVC) is a novel, orally administered, potent chemokine 2 and 5 receptor antagonist currently in development for the treatment of liver fibrosis in adults with NASH. Methods and analysis: Efficacy and safety of CVC will be comprehensively evaluated in a global, Phase 3, multicenter, randomized, double-blind, placebo-controlled study (AURORA, NCT03028740) of subjects with NASH and Stage F2 or F3 fibrosis. Approximately 2000 adults (Part 1, 1200 subjects; Part 2, 800 additional subjects) aged 18–75 years with histological evidence of NASH with Stage F2 or F3 fibrosis (NASH Clinical Research Network classification system) will be randomized 2:1 to CVC 150 mg or placebo orally once daily. Primary efficacy endpoints will include the proportion of subjects with ≥1-stage improvement in liver fibrosis and no worsening of steatohepatitis at Month 12 relative to screening (Part 1), and time to first occurrence of any adjudicated event: death; histopathologic progression to cirrhosis; liver transplant; Model of End-Stage Liver Disease score ≥ 15; ascites; hospitalization due to liver decompensation (Part 2). Patient-reported outcomes will assess changes in health outcomes from baseline (Chronic Liver Disease Questionnaire - NAFLD; Work Productivity and Activity Impairment in NASH; 36-Item Short Form Health Survey version 2). Adverse events will be assessed throughout the study. As there are currently no approved treatments indicated for NASH, the AURORA CVC Phase 3 study addresses an unmet medical need.


Publication metadata

Author(s): Anstee QM, Neuschwander-Tetri BA, Wong VW-S, Abdelmalek MF, Younossi ZM, Yuan J, Pecoraro ML, Seyedkazemi S, Fischer L, Bedossa P, Goodman Z, Alkhouri N, Tacke F, Sanyal A

Publication type: Article

Publication status: Published

Journal: Contemporary Clinical Trials

Year: 2020

Volume: 89

Print publication date: 01/02/2020

Online publication date: 24/12/2019

Acceptance date: 23/12/2019

Date deposited: 08/01/2020

ISSN (print): 1551-7144

ISSN (electronic): 1559-2030

Publisher: Elsevier Inc.

URL: https://doi.org/10.1016/j.cct.2019.105922

DOI: 10.1016/j.cct.2019.105922


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