AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH) (AURORA)

February 11, 2022 updated by: Tobira Therapeutics, Inc.

AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis

The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult participants with NASH.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The AURORA study will be conducted in 2 parts. Part 1 will examine the surrogate endpoint of improvement in fibrosis of at least 1 stage (nonalcoholic steatohepatitis clinical research network [NASH CRN]) and no worsening of steatohepatitis at Month 12. Participants from Part 1 will continue into Part 2 and additional participants will be newly randomized in Part 2 to determine long-term clinical outcomes composed of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality.

Study Type

Interventional

Enrollment (Actual)

1778

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Kogarah, New South Wales, Australia, 2217
        • Saint George Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Adelaide, South Australia, Australia, 5042
        • Flinders Medical Center
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Universitatsklinik far Innere Medizin
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Universitatsklinik far Innere Medizin II
    • Upper Austria
      • Wels, Upper Austria, Austria, 4600
        • Klinikum Wels-Grieskirchen
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Liege, Belgium, 4000
        • Centre Hospitalier Chretien CHC
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
    • Brussels
      • Bruxelles, Brussels, Belgium, 1070
        • Hôpital Erasme
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Algemeen Ziekenhuis Maria Middelares
  • Brazil
      • Rio de Janeiro, Brazil, 21941-913
        • Hospital Universitario Clementino Fraga Filho
      • Sao Paulo, Brazil, 05403-000
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Hospital das Clinicas da Universidade Federal de Minas Gerais
    • Sao Paulo
      • São José do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Faculdade de Medicina de Sao Jose do Rio Preto Hospital de Base
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary Liver Unit
      • Edmonton, Alberta, Canada, T5H 4B9
        • Bailey Health Clinic
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health Centre, Brampton Memorial Hospital Campus
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
  • Chile
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2540488
        • Centro de Investigaciones Clinicas Viña del Mar
  • France
      • Bobigny, France, 93000
        • Hopital Avicenne
    • Alsace
      • Strasbourg cedex, Alsace, France, 67091
        • CHU de Strasbourg
    • Aquitaine
      • Pessac, Aquitaine, France, 33604
        • CHU De Bordeaux - Hôpital Haût-Lévèque CMC Magellan Unita de Recherche Clinique
    • Aubergne
      • Clermont-Ferrand, Aubergne, France, 63003
        • Centre Hospitalier Universitaire Estaing
    • Bretagne
      • Rennes, Bretagne, France, 35033
        • Centre Hospitalier Universitaire de Rennes- Hôpital Pontchaillou
    • Franche-Comte
      • Besançon cedex, Franche-Comte, France, 25030
        • Centre Hospitalier Regional et Universitaire de Besancon - L'Hopital Jean Minjoz
    • Ile-De-France
      • Clichy, Ile-De-France, France, 92110
        • Departement d'Hacpatologie
    • Ile-de-France
      • Paris Cedex 12, Ile-de-France, France, 75571
        • Hopital Saint Antoine
    • Languedoc-Roussillon
      • Montpellier cedex 5, Languedoc-Roussillon, France, 34295
        • CHU de Montpellier
    • Normandie
      • Rouen, Normandie, France, 76000
        • Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle
    • Pays De La Loire
      • Angers, Pays De La Loire, France, 49000
        • Center Hospitalier Universitaire d'Angers
    • Picardie
      • Amiens Cedex 1, Picardie, France, 80054
        • Hapital Sud Service d'Hepato- Gastroentarologie
    • Provence Alpes Cote D'Azur
      • Nice Cedex 3, Provence Alpes Cote D'Azur, France, 06202
        • Centre Hospitalier Universitaire de Nice Hôpital l'Archet
    • Rhone-Alpes
      • Grenoble Cedex 09, Rhone-Alpes, France, 38700
        • Centre Hospitalier Universitaire Grenoble
  • Germany
      • Berlin, Germany, 13353
        • Charite Universitatsmedizin Berlin
      • Berlin, Germany, 10439
        • Praxis Driesener Strasse
      • Berlin, Germany, 12627
        • Synexus Clinical Research GmbH, Prüfzentrum Berlin
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg Eppendorf
    • Hessen
      • Frankfurt, Hessen, Germany, 60313
        • Synexus Clinical Research GmbH, Prüfzentrum Frankfurt
      • Marburg, Hessen, Germany, 35043
        • Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
    • Nordhein-Westfalen
      • Herne, Nordhein-Westfalen, Germany, 44623
        • Gastroenterologische Gemeinschaftspraxis
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
        • Uniklinik RWTH Aachen
    • Nordrhein-westfalen
      • Köln, Nordrhein-westfalen, Germany, 50937
        • Uniklinik Köln
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg Universität Mainz
    • Saarland
      • Homburg, Saarland, Germany, 66427
        • Universitätsklinikum des Saarlandes
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Universitätsklinikum Leipzig
  • Greece
      • Thessaloniki, Greece, 54642
        • Hippokratio Hospital
    • Peloponnese
      • Patra, Peloponnese, Greece, 26504
        • Thomopoulos Gastroenterology Dept.
  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong, 00852
        • Prince of Wales Hospital
      • Shatin, New Territories, Hong Kong
        • Alice Ho Miu Ling Nethersole Hospital
  • Hungary
      • Budapest, Hungary, 1036
        • SYNEXUS Magyarország Kft. - Budapest DRS
      • Debrecen, Hungary, 4025
        • SYNEXUS Magyarország Egészségügyi Szolgáltató KFT
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400-7400
        • Somogy Megyei Kaposi Mor Oktato Korhaz
  • Israel
      • Haifa, Israel, 34362
        • Carmel Medical Center
      • Haifa, Israel, 31999
        • Rambam Health Care Campus - Rambam Medical Center
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center, Institute of Gastroenterology and Liver Diseases
      • Nahariya, Israel, 22100
        • Galilee Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center Beilinson Hospital
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
      • Tel-Hashomer, Israel, 52621
        • Sheba Medical Center
    • Jerusalem
      • Nazareth, Jerusalem, Israel, 91031
        • EMMS MC
  • Italy
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi SOD Medicina Interna ed Epatologia
      • Milano, Italy, 20142
        • Asst Santi Paolo E Carlo
      • Palermo, Italy, 90127
        • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli
      • Roma, Italy, 00133
        • Fondazione Policlinico Tor Vergata
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Ospedale Casa Sollievo della Sofferenza
    • Milano
      • Milan, Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
  • Latvia
      • Riga, Latvia, LV-1002-1002
        • Pauls Stradins Clinical University Hospital
  • Mexico
      • Metepec, Mexico, 52140
        • Consultorio Dra. Maria Sarai Gonzalez Huezo
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06700
        • Consultorio Médico Dr. Alma Laura Ladron de Guevara
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62290
        • JM Research - Cuernavaca
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64000
        • Investigaciones Medicas Cisneros
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Papatoetoe, Auckland, New Zealand, 2025
        • Middlemore Clinical Trials
  • Norway
      • Oslo, Norway, 0450
        • Oslo Universitetssykehus-Ullevål
  • Poland
      • Czestochowa, Poland, 0 42-202
        • Synexus Polska Sp. z o.o. Oddzial w Czestochowie
      • Gdańsk, Poland, 80-382
        • Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdynia, Poland, 81-537
        • Synexus Polska Sp. z o.o. Oddzial w Gdyni ul.
      • Katowice, Poland, 40-040
        • Synexus SCM Sp. z o.o. Oddzial
      • Warsaw, Poland, 01-192
        • Synexus Polska Sp. z o.o. Oddział w Warszawie
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 51-162
        • Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
      • Wroclaw, Dolnoslaskie, Poland, 54-144
        • EMC Instytut Medyczny
    • Lodz
      • Łódź, Lodz, Poland, 90-127
        • Synexus Polska Sp. z o.o. Oddział w Łodzi
    • Lodzkie
      • Lódz, Lodzkie, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi
    • Slaskie
      • Bytom, Slaskie, Poland, 41-902
        • Szpital Specjalistyczny nr 1 w Bytomiu
      • Myslowice, Slaskie, Poland, 41400-400
        • ID Clinic Arkadiusz Pisula
    • Wielkopolska
      • Poznań, Wielkopolska, Poland, 60 702-702
        • Synexus Polska Sp z o o Oddzial w Poznaniu
    • Wroclaw
      • Wrocław, Wroclaw, Poland, 50-381
        • Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
  • Portugal
      • Viana do Castelo, Portugal, 4904-858
        • Unidade Local de Saúde do Alto Minho
    • Lordelo
      • Vila Real, Lordelo, Portugal, 5000-508
        • Presa-Ramos
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
      • San Juan, Puerto Rico, 00909-1711
        • Clinical Research Puerto Rico
  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400162
        • Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor
  • Russian Federation
      • Moscow, Russian Federation, 129090
        • Sklifosovsky Scientific Research Institution of Emergency Care
      • Moscow, Russian Federation, 129110
        • Moscow Regional Research and Clinical Institute M.F. Vladimirsky
    • Moscow
      • Krasnogorsk, Moscow, Russian Federation, 143405
        • Clinic Professor Gorbakova
  • Singapore
      • Singapore, Singapore, 119082
        • National University Hospital
  • Spain
      • Almeria, Spain, 4009
        • Complejo Hospitalario Torrecardenas
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Málaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
      • Santander, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spain, 41014
        • Hospital Universitario Nuestra Senora De Valme
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
      • Valencia, Spain, 46014
        • Consorci Hospital General Universitari de València
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias I Pujol
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20014
        • Hospital Universitario Donostia
  • Switzerland
      • Bern, Switzerland, 3010
        • Universitaetsspital Bern Inselspital
    • Saint Gallen
      • St. Gallen, Saint Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen Klinik für
  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
    • Chiayi
      • Chiayi City, Chiayi, Taiwan, 60002
        • Chia-Yi Christian Hospital
    • Taichung City
      • Taichung, Taichung City, Taiwan, 404
        • China Medical University Hospital
  • United Kingdom
      • Hexham, United Kingdom, NE46 1QJ
        • Synexus Hexham Clinical Research Centre
      • Lancaster, United Kingdom, PR7 7NA
        • Synexus Lancashire Clinical Research Centre
      • London, United Kingdom, E1 1BB
        • Barts Health NHS Trust The Royal London Hospital
      • Manchester, United Kingdom, M23 9LT
        • University Hospital of South Manchester NHS Foundation Trust
    • England
      • Birmingham, England, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust
      • Hull, England, United Kingdom, HU3 2JZ
        • Hull and East Yorkshire Hospitals NHS Trust
      • London, England, United Kingdom, SE5 9RS
        • Kings College Hospital NHS Foundation Trust
      • London, England, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, England, United Kingdom, SW10 9NH
        • Chelsea and Westminster Hospital NHS Foundation Trust
      • Luton, England, United Kingdom, LU4 0DZ
        • Luton and Dunstable Hospital NHS Foundation Trust
      • Newcastle, England, United Kingdom, NE2 7DN
        • Newcastle Upon the Tyne Hospitals
      • Nottingham, England, United Kingdom, NG7 2UH
        • Nottingham Digestive Diseases Biomedical Research Unit
      • Plymouth, England, United Kingdom, PL6 8DH
        • Plymouth Hospitals Nhs Trust
      • Stoke-on-Trent, England, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS97TF
        • St James's University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Summit Internal Medicine
      • Cullman, Alabama, United States, 35055
        • Cullman Clinical Trials
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists Of The Southeast
      • Madison, Alabama, United States, 35758
        • Objective GI d/b/a North Alabama GI Research Center
    • Arizona
      • Chandler, Arizona, United States, 85224
        • The Institute for Liver Health
      • Tucson, Arizona, United States, 85712
        • Del Sol Research Management, LLC
      • Tucson, Arizona, United States, 85712
        • Adobe Gastroenterology Research, LLC
      • Tucson, Arizona, United States, 85745
        • Del Sol Research Management LLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Diagnostic Center
    • California
      • Bakersfield, California, United States, 93301
        • Franco Felizarta MD
      • Canoga Park, California, United States, 91303
        • Hope Clinical Research
      • Chula Vista, California, United States, 91911
        • eStudySite
      • Chula Vista, California, United States, 91910
        • GW Research
      • Coronado, California, United States, 92118
        • Southern California Research Center
      • Covina, California, United States, 91722
        • Citrus Valley Gastroenterology
      • El Cajon, California, United States, 92020
        • TriWest Research Associates
      • Fresno, California, United States, 93701
        • University of San Francisco, Fresno Medical Education Program
      • Fresno, California, United States, 93720
        • Fresno Clinical Research Center (FCRC)
      • Huntington Park, California, United States, 90255
        • National Research Institute
      • La Jolla, California, United States, 92037
        • University of California San Diego
      • La Mesa, California, United States, 91942
        • eStudySite
      • Lancaster, California, United States, 93534
        • Om Research
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Group
      • Los Angeles, California, United States, 90027
        • Southern California Kaiser Permanente, Los Angeles Medical Center
      • Los Angeles, California, United States, 90036
        • GastroIntestinal BioSciences
      • Los Angeles, California, United States, 90036
        • Global Research Institute
      • Los Angeles, California, United States, 90036
        • Ruane Medical and Liver Health Institute
      • Murrieta, California, United States, 92563
        • United Medical Doctors
      • Palm Springs, California, United States, 92262
        • Palmtree Clinical Research Inc.
      • Panorama City, California, United States, 91402
        • National Research Institute
      • Pasadena, California, United States, 91105
        • Pasadena Liver Center
      • Poway, California, United States, 92064
        • Alliance Clinical Research LLC
      • Redwood City, California, United States, 94063
        • Stanford School of Medicine, Center for Clinical Sciences Research
      • Rialto, California, United States, 92377-4697
        • Inland Empire Liver Foundation
      • San Diego, California, United States, 92114
        • Precision Research Institute
      • San Diego, California, United States, 92154
        • Southern California Permanente Medical Group
      • San Francisco, California, United States, 94143-0538
        • UCSF School of Medicine
      • Upland, California, United States, 91786
        • Upland Clinical Research
      • Ventura, California, United States, 93003
        • Island View GI
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Peak Gastroenterology Associates
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology, PC
      • Wheat Ridge, Colorado, United States, 80033
        • Western States Clinical Research, Inc.
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Gastroenterology Associates of Fairfield County
      • New Haven, Connecticut, United States, 06511
        • Yale University - New Haven
    • Florida
      • Aventura, Florida, United States, 33180
        • Innovative Medical Research of South Florida, Inc.
      • Clearwater, Florida, United States, 33761
        • Gastro Florida
      • Coral Gables, Florida, United States, 33134
        • Hi Tech and Global Research, LLC
      • Cutler Bay, Florida, United States, 33189
        • Top Medical Research, Inc
      • Doral, Florida, United States, 33166
        • ICR Sites
      • Hialeah, Florida, United States, 33010
        • Qway Research, LLC
      • Inverness, Florida, United States, 34452
        • Gastroenterology Associates - Crystal River
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic College of Medicine
      • Lakeland, Florida, United States, 33803
        • Meridien Research
      • Lakewood Ranch, Florida, United States, 34211
        • Florida Digestive Health Specialists
      • Maitland, Florida, United States, 32751
        • Meridien Research
      • Miami, Florida, United States, 33014
        • Clinical Pharmacology of Miami, LLC
      • Miami, Florida, United States, 33157
        • Sanchez Clinical Research, Inc
      • Miami, Florida, United States, 33136
        • University of Miami Hospital
      • Miami, Florida, United States, 33125
        • Optimus U Corporation
      • Miami, Florida, United States, 33175
        • ProLive Medical Research
      • Miami, Florida, United States, 33125
        • Bruce W. Carter Department of Veterans Affairs Medical Center
      • Miami, Florida, United States, 33165
        • Genoma Research Group Inc.
      • Miami, Florida, United States, 33165
        • Medical Professional Clinical Research Center, Inc
      • Miami Lakes, Florida, United States, 33014
        • San Marcus Research Clinic
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute, Inc.
      • Orlando, Florida, United States, 32806
        • Bioclinical Research Alliance
      • Orlando, Florida, United States, 32810
        • Omega Research Maitland, LLC
      • Palmetto Bay, Florida, United States, 33157
        • Innovation Medical Research Center
      • Palmetto Bay, Florida, United States, 33157
        • IMIC, Inc
      • Pensacola, Florida, United States, 32503
        • Gastroenterology Associates of Pensacola
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • Tampa, Florida, United States, 33614
        • Guardian Angel Research Center
      • The Villages, Florida, United States, 32162
        • Bioclinica Research
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic
    • Georgia
      • Athens, Georgia, United States, 30607
        • Summit Clinical Research, LLC
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia - Atlanta
      • Atlanta, Georgia, United States, 30309
        • Piedmont Healthcare Inc.
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia
      • Marietta, Georgia, United States, 30060
        • GI Specialists of Georgia - Marietta Office
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Investigators Research Group, Llc
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology Research Foundation
      • New Albany, Indiana, United States, 47150
        • Aquiant Research
      • South Bend, Indiana, United States, 46635
        • Digestive Research Alliance of Michiana
    • Iowa
      • Clive, Iowa, United States, 50325
        • Iowa Digestive Disease Center
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Topeka, Kansas, United States, 66606
        • Kansas Medical Clinic-Gastroenterology
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • Delta Research Partners, LLC
      • Crowley, Louisiana, United States, 70526
        • Avant Research Associates LLC
      • Lake Charles, Louisiana, United States, 70601
        • C-1 Headlands, Inc.
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
      • New Orleans, Louisiana, United States, 70125
        • Nola Research Works, LLC
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center
      • West Monroe, Louisiana, United States, 71291
        • Clinical Trials of America LLC
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Catonsville, Maryland, United States, 21228
        • Digestive Disease Associates
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Woodholme Gastroenterology Associates
      • Greenbelt, Maryland, United States, 20770
        • Victory Clinical Research
      • Hagerstown, Maryland, United States, 21742
        • Meritus Center for Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center
      • Worcester, Massachusetts, United States, 01655
        • UMASS Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Maplewood, Minnesota, United States, 55117
        • Minnesota Gastroenterology, P.A.
    • Mississippi
      • Biloxi, Mississippi, United States, 39532
        • National Diabetes and Obesity Research Institute
      • Flowood, Mississippi, United States, 39232
        • Gastrointestinal Associates
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Clinical Research Professionals
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Sierra Clinical Research
      • Las Vegas, Nevada, United States, 89106
        • Jubilee Clinical Research, Inc.
      • Las Vegas, Nevada, United States, 89109
        • Excel Clinical Research
      • Las Vegas, Nevada, United States, 89104
        • Machuca Family Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
      • Raritan, New Jersey, United States, 08869
        • Amici Clinical Research
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10016
        • NYU Langone Health - Perlmutter Cancer Center
      • New York, New York, United States, 10033
        • Tandem Clinical Research
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Investigational Drug Service, The University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center
      • Concord, North Carolina, United States, 28027
        • Northeast GI Research Division
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates, LLC
      • Greenville, North Carolina, United States, 27834
        • Carolina Research
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Consultants for Clinical Research
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43210
        • The Ohio University - Gastroenterology, Hepatology
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialist, Inc.
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Eastern Pennsylvania Gastroenterology and Liver Specialist
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC -Center for Liver Diseases
      • Pottsville, Pennsylvania, United States, 17901
        • Care Access Research, Pottsville
      • Wyomissing, Pennsylvania, United States, 19610
        • Digestive Disease Associates, LTD
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Partners in Clinical Research
      • North Providence, Rhode Island, United States, 02908
        • University Medical Group
      • Warwick, Rhode Island, United States, 02886
        • Care Access Research-Warwick
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Medical Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Mount Vernon Clinical Research
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Hermitage, Tennessee, United States, 37076
        • Digestive Health Research
      • Johnson City, Tennessee, United States, 37604
        • East Tennessee Research Institute
      • Lebanon, Tennessee, United States, 37090
        • Digestive Health Research
      • Memphis, Tennessee, United States, 38104
        • UT-Memphis, Methodist University Hospital
      • Nashville, Tennessee, United States, 37232-1610
        • Vanderbilt University
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75234
        • Liver Center of Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center
      • Dallas, Texas, United States, 75234
        • Synexus
      • Fort Sam Houston, Texas, United States, 78234
        • San Antonio Military Medical Center
      • Fort Worth, Texas, United States, 76104
        • Baylor Scott & White All Saints Medical Center - Ft. Worth
      • Fort Worth, Texas, United States, 76104
        • Texas Digestive Disease Consultants - Fort Worth
      • Garland, Texas, United States, 75044
        • Digestive Health Associates of Texas-Rockwall
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77084
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77089
        • Amir Ali Hassan, MD, PA
      • Houston, Texas, United States, 77004
        • Therapeutic Concepts, PA
      • Houston, Texas, United States, 77058
        • Centex Studies
      • Houston, Texas, United States, 77009
        • Pioneer Research Solutions, Inc.
      • Houston, Texas, United States, 77030-3002
        • Liver Associates of Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center (MEDVAMC)
      • Houston, Texas, United States, 77030
        • St. Luke's Medical Center
      • McAllen, Texas, United States, 78504
        • Centex Studies, Inc.
      • Pearland, Texas, United States, 77584
        • LinQ Research, LLC
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials, LLC
      • San Antonio, Texas, United States, 78209
        • Quality Research Inc.
      • San Antonio, Texas, United States, 78215
        • American Research Corporation
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas Inc
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Clinic, P.A. (DGD)
      • San Antonio, Texas, United States, 78229
        • Southern Star Research Institute, LLC SAGACT PLLC.
      • San Antonio, Texas, United States, 78260
        • Anson Medicine
      • Sugar Land, Texas, United States, 77479
        • Mount Olympus Medical Research, LLC
      • Webster, Texas, United States, 77598
        • Texas Digestive Disease Consultants
    • Utah
      • Draper, Utah, United States, 84020
        • Physician's Research Options, LLC
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Riverton, Utah, United States, 84065
        • Advanced Clinical Research - Center for Digestive Health
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Gastroenterology Associates of Northern Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus
      • Newport News, Virginia, United States, 23602
        • Liver Institute of Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, United States, 23249
        • McGuire Veterans Affairs Medical Center
      • Richmond, Virginia, United States, 23298
        • VCU Medical Center
      • Roanoke, Virginia, United States, 24014
        • Gastroenterology Consultants of Southwest Virginia Research
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98105
        • Liver Institute Northwest
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Marshall University Joan C. Edwards School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female participants aged between 18-75 years
  • Ability to understand and sign a written informed consent form (ICF)
  • Histological evidence of NASH based on central reading of the Screening biopsy
  • Participants included in Part 1 must have histopathological evidence of Stage 2 or 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides. Participants newly randomized in Part 2 must have histological evidence of Stage 3 liver fibrosis per the NASH CRN System, based on central reading of the Screening period biopsy slides. Historical biopsy can be used, provided the criteria listed on Item 3a above are fulfilled.
  • Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for ≥12 months and serum follicle-stimulating hormone (FSH) ≥30 milliunits (mU)/milliliter (mL) at Screening.

Exclusion Criteria:

  • Inability to undergo a liver biopsy
  • Hepatitis B surface antigen (HBsAg) positive
  • Hepatitis C antibody (HCVAb) positive
  • Human immunodeficiency virus (HIV)-1 or HIV-2 infection
  • Prior or planned liver transplantation
  • Other known causes of chronic liver disease
  • History or presence of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
  • Alcohol consumption greater than 21 units/week for males or 14 units/week for females
  • Aspartate transaminase (AST) >200 International units (IU)/liter (L) in males and females at Screening
  • Alanine transaminase (ALT) >250 IU/L in males and >200 IU/L in females at Screening
  • Hemoglobin A1c (HbA1c) >10% at Screening
  • Serum albumin <3.5 gram (g)/deciliter (dL) at Screening
  • Estimated glomerular filtration rate (eGFR) < 50 mL/minute (min)/1.73 meter (m)^2 according to the Modification of Diet in Renal Disease (MDRD) equation
  • Platelet count <100,000/millimeter (mm)^3
  • Total bilirubin >1.5 milligram (mg)/dL
  • International normalized ratio (INR) >1.3
  • Model of end stage liver disease (MELD) score >12
  • Weight reduction, defined as ≥7% of body weight, through bariatric surgery in the past 5 years or bariatric surgery planned during the conduct of the study (including gastric banding and sleeve surgery)
  • History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
  • Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
  • Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
  • Females who are pregnant or breastfeeding
  • Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (eg, interleukins, interferons, cyclosporine, tacrolimus) except for vaccines or short-term corticosteroids
  • Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) and/or sodium-glucose cotransporter (SGLT1) inhibitor, or a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver biopsy. Participants on a stable therapy with a GLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for at least 6 months prior to the Screening liver biopsy may be considered eligible. (Important Note: if a historical biopsy is to be used, participants need to be on stable therapy for at least 6 months prior to the day historical liver biopsy was performed).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Drug: Placebo
Cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Experimental: Cenicriviroc 150 mg
Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.
Drug: Cenicriviroc
Cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Other Names:
  • CVC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Histology at Month 12
Time Frame: Month 12
Fibrosis stage was evaluated using the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant nonalcoholic fatty liver disease activity score (NAS) categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Month 12
Time to First Occurrence of Adjudicated Events in the Full Study Cohort
Time Frame: From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months)
Time to first occurrence from Baseline was defined as the number of days from the first dose of randomized investigational product to the onset of the first occurrence of any of the following adjudicated events: death (all cause), histopathologic progression to cirrhosis, liver transplant, model for end stage liver disease (MELD) score ≥15, ascites, hospitalization for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis. MELD is a scoring system for assessing the severity of chronic liver disease and uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores10-19=6.0% mortality; Score 9 or less=1.9% mortality.
From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Histology at Month 12
Time Frame: Month 12
Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Month 12
Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12
Time Frame: Month 12
Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
Month 12
Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12
Time Frame: Month 12
Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
Month 12
Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
Time Frame: Month 12
Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Month 12
Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
Time Frame: Month 12
Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
Month 12
Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
Time Frame: Month 12
Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Month 12
Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort
Time Frame: Month 12
Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
Month 12
Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
Time Frame: Month 60
Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Month 60
Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
Time Frame: Month 60
Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
Month 60
Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
Time Frame: Month 60
Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
Month 60
Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis on Liver Biopsy at Month 60 in the Full Study Cohort
Time Frame: Month 60
Fibrosis stage was evaluated using NASH CRN Fibrosis Staging System with stages 0=None, 1=Perisinusoidal or periportal, 1A=Mild, zone 3, perisinusoidal, 1B=Moderate, zone 3, perisinusoidal, 1C=Portal/periportal, 2=Perisinusoidal and portal/periportal, 3=Bridging fibrosis, 4=Cirrhosis.
Month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tobira Therapeutics, Inc.

Investigators

  • Study Director: Gerardo Rodriguez, Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2017

Primary Completion (Actual)

January 12, 2021

Study Completion (Actual)

March 9, 2021

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

February 11, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3152-301-002
  • 1001 (Registro Nacional Estudios Clinicos (RNEC))
  • 2016-004566-26 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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