AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT03028740
Last Updated: 2022-03-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1778 participants
INTERVENTIONAL
2017-04-05
2021-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Placebo
Cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Cenicriviroc 150 mg
Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.
Cenicriviroc
Cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Interventions
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Placebo
Cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Cenicriviroc
Cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
75 Years
ALL
No
Sponsors
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Tobira Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gerardo Rodriguez
Role: STUDY_DIRECTOR
Allergan
Locations
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Summit Internal Medicine
Birmingham, Alabama, United States
Cullman Clinical Trials
Cullman, Alabama, United States
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Objective GI D/B/A North Alabama GI Research Center
Madison, Alabama, United States
The Institute for Liver Health
Chandler, Arizona, United States
Adobe Gastroenterology Research, LLC
Tucson, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
Del Sol Research Management LLC
Tucson, Arizona, United States
Arkansas Diagnostic Center
Little Rock, Arkansas, United States
Franco Felizarta MD
Bakersfield, California, United States
Hope Clinical Research
Canoga Park, California, United States
GW Research
Chula Vista, California, United States
eStudySite
Chula Vista, California, United States
Southern California Research Center
Coronado, California, United States
Citrus Valley Gastroenterology
Covina, California, United States
TriWest Research Associates
El Cajon, California, United States
University of San Francisco, Fresno Medical Education Program
Fresno, California, United States
Fresno Clinical Research Center (FCRC)
Fresno, California, United States
National Research Institute
Huntington Park, California, United States
University of California San Diego
La Jolla, California, United States
eStudySite
La Mesa, California, United States
Om Research
Lancaster, California, United States
Southern California Kaiser Permanente, Los Angeles Medical Center
Los Angeles, California, United States
GastroIntestinal Biosciences
Los Angeles, California, United States
Global Research Institute
Los Angeles, California, United States
Ruane Medical and Liver Health Institute
Los Angeles, California, United States
Cedars-Sinai Medical Group
Los Angeles, California, United States
National Research Institute
Los Angeles, California, United States
United Medical Doctors
Murrieta, California, United States
Palmtree Clinical Research Inc.
Palm Springs, California, United States
National Research Institute
Panorama City, California, United States
Pasadena Liver Center
Pasadena, California, United States
Alliance Clinical Research LLC
Poway, California, United States
Stanford School of Medicine, Center for Clinical Sciences Research
Redwood City, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Precision Research Institute
San Diego, California, United States
Southern California Permanente Medical Group
San Diego, California, United States
UCSF School of Medicine
San Francisco, California, United States
Upland Clinical Research
Upland, California, United States
Island View GI
Ventura, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
South Denver Gastroenterology, PC
Englewood, Colorado, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States
Yale University - New Haven
New Haven, Connecticut, United States
Innovative Medical Research of South Florida, Inc.
Aventura, Florida, United States
Gastro Florida
Clearwater, Florida, United States
Hi Tech and Global Research, LLC
Coral Gables, Florida, United States
Top Medical Research, Inc
Cutler Bay, Florida, United States
ICR Sites
Doral, Florida, United States
Qway Research, LLC
Hialeah, Florida, United States
Gastroenterology Associates - Crystal River
Inverness, Florida, United States
Mayo Clinic College of Medicine
Jacksonville, Florida, United States
Meridien Research
Lakeland, Florida, United States
Florida Digestive Health Specialists
Lakewood Rch, Florida, United States
Meridien Research
Maitland, Florida, United States
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States
Bruce W. Carter Department of Veterans Affairs Medical Center
Miami, Florida, United States
Optimus U Corporation
Miami, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Sanchez Clinical Research, Inc
Miami, Florida, United States
Genoma Research Group Inc.
Miami, Florida, United States
Medical Professional Clinical Research Center, INC
Miami, Florida, United States
ProLive Medical Research
Miami, Florida, United States
San Marcus Research Clinic
Miami Lakes, Florida, United States
Advanced Research Institute, Inc.
New Port Richey, Florida, United States
Bioclinical Research Alliance
Orlando, Florida, United States
Omega Research Maitland, LLC
Orlando, Florida, United States
IMIC, Inc
Palmetto Bay, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
Gastroenterology Associates of Pensacola
Pensacola, Florida, United States
Advanced Medical Research
Port Orange, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Guardian Angel Research Center
Tampa, Florida, United States
Bioclinica Research
The Villages, Florida, United States
Florida Medical Clinic
Zephyrhills, Florida, United States
Summit Clinical Research, LLC
Athens, Georgia, United States
Digestive Healthcare of Georgia - Atlanta
Atlanta, Georgia, United States
Piedmont Healthcare INC.
Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States
GI Specialists of Georgia - Marietta Office
Marietta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Investigators Research Group, LLC
Brownsburg, Indiana, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
Aquiant Research
New Albany, Indiana, United States
Digestive Research Alliance of Michiana
South Bend, Indiana, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas Medical Clinic-Gastroenterology
Topeka, Kansas, United States
Delta Research Partners, LLC
Bastrop, Louisiana, United States
Avant Research Associates LLC
Crowley, Louisiana, United States
C-1 Headlands, Inc.
Lake Charles, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Nola Research Works, LLC
New Orleans, Louisiana, United States
Louisiana Research Center
Shreveport, Louisiana, United States
Clinical Trials of America LLC
West Monroe, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Digestive Disease Associates
Catonsville, Maryland, United States
Gastro Center of Maryland
Columbia, Maryland, United States
Woodholme Gastroenterology Associates
Glen Burnie, Maryland, United States
Victory Clinical Research
Greenbelt, Maryland, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Umass Memorial Medical Center
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Minnesota Gastroenterology, P.A.
Maplewood, Minnesota, United States
National Diabetes and Obesity Research Institute
Biloxi, Mississippi, United States
GastroIntestinal Associates
Flowood, Mississippi, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Machuca Family Medicine
Las Vegas, Nevada, United States
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States
Sierra Clinical Research
Las Vegas, Nevada, United States
Excel Clinical Research
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Hassman Research Institute
Berlin, New Jersey, United States
Amici Clinical Research
Raritan, New Jersey, United States
Beth Israel Medical Center
New York, New York, United States
NYU Langone Health - Perlmutter Cancer Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Tandem Clinical Research
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Investigational Drug Service, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Northeast GI Research Division
Concord, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States
Carolina Research
Greenville, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
The Ohio University - Gastroenterology, Hepatology
Columbus, Ohio, United States
Digestive Disease Specialist, Inc.
Oklahoma City, Oklahoma, United States
Options Health Research
Tulsa, Oklahoma, United States
Eastern Pennsylvania Gastroenterology and Liver Specialist
Bethlehem, Pennsylvania, United States
UPMC -Center for Liver Diseases
Pittsburgh, Pennsylvania, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Care Access Research, Pottsville
Pottsville, Pennsylvania, United States
Digestive Disease Associates, LTD
Wyomissing, Pennsylvania, United States
Partners in Clinical Research
Cumberland, Rhode Island, United States
University Medical Group
North Providence, Rhode Island, United States
Care Access Research-Warwick
Warwick, Rhode Island, United States
Rapid City Medical Center
Rapid City, South Dakota, United States
Mount Vernon Clinical Research
Chattanooga, Tennessee, United States
Gastro One
Germantown, Tennessee, United States
Digestive Health Research
Hermitage, Tennessee, United States
East Tennessee Research Institute
Johnson City, Tennessee, United States
Digestive Health Research
Lebanon, Tennessee, United States
UT-Memphis, Methodist University Hospital
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
Liver Center of Texas
Dallas, Texas, United States
Synexus
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States
Baylor Scott & White All Saints Medical Center - Ft. Worth
Fort Worth, Texas, United States
Texas Digestive Disease Consultants - Fort Worth
Fort Worth, Texas, United States
Digestive Health Associates of Texas-Rockwall
Garland, Texas, United States
Therapeutic Concepts, PA
Houston, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Liver Associates of Texas
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Michael E. DeBakey VA Medical Center (MEDVAMC)
Houston, Texas, United States
St. Luke's Medical Center
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Centex Studies
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
Amir Ali Hassan, MD, PA
Houston, Texas, United States
Centex Studies, Inc.
McAllen, Texas, United States
LinQ Research, LLC
Pearland, Texas, United States
Quality Research Inc.
San Antonio, Texas, United States
American Research Corporation
San Antonio, Texas, United States
Clinical Trials of Texas Inc
San Antonio, Texas, United States
Diabetes & Glandular Disease Clinic, P.A. (DGD)
San Antonio, Texas, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States
Southern Star Research Institute, LLC SAGACT PLLC.
San Antonio, Texas, United States
Anson Medicine
San Antonio, Texas, United States
Mount Olympus Medical Research, LLC
Sugar Land, Texas, United States
Texas Digestive Disease Consultants
Webster, Texas, United States
Physician's Research Options, LLC
Draper, Utah, United States
Intermountain Medical Center
Murray, Utah, United States
Advanced Clinical Research - Center for Digestive Health
Riverton, Utah, United States
University of Utah
Salt Lake City, Utah, United States
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Liver Institute of Virginia
Newport News, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States
VCU Medical Center
Richmond, Virginia, United States
Gastroenterology Consultants of Southwest Virginia Research
Roanoke, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Liver Institute Northwest
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Marshall University Joan C. Edwards School of Medicine
Huntington, West Virginia, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Saint George Hospital
Kogarah, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Center
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Universitatsklinik far Innere Medizin
Graz, Styria, Austria
Universitatsklinik far Innere Medizin II
Innsbruck, Tyrol, Austria
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, Belgium
Hôpital Erasme
Brussels, Brussels Capital, Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Centre Hospitalier Chretien CHC
Liège, , Belgium
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Faculdade de Medicina de São José do Rio Preto Hospital de Base
São José do Rio Preto, São Paulo, Brazil
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, , Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, , Brazil
University of Calgary Liver Unit
Calgary, Alberta, Canada
Bailey Health Clinic
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
William Osler Health Centre, Brampton Memorial Hospital Campus
Brampton, Ontario, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Centro de Investigaciones Clínicas Viña del Mar
Viña del Mar, Región de Valparaíso, Chile
CHU de Strasbourg
Strasbourg, Alsace, France
CHU De Bordeaux - Hôpital Haût-Lévèque CMC Magellan Unita de Recherche Clinique
Pessac, Aquitaine, France
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, Aubergne, France
Centre Hospitalier Universitaire Grenoble
Grenoble, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire de Rennes- Hôpital Pontchaillou
Rennes, Brittany Region, France
Centre Hospitalier Regional et Universitaire de Besancon - L'Hopital Jean Minjoz
Besançon, Franche-Comte, France
CHU de Montpellier
Montpellier, Languedoc-Roussillon, France
Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle
Rouen, Normandy, France
Center Hospitalier Universitaire d'Angers
Angers, Pays de la Loire Region, France
Hapital Sud Service d'Hepato- Gastroentarologie
Amiens, Picardie, France
Centre Hospitalier Universitaire de Nice Hôpital l'Archet
Nice, Provence-Alpes-Côte d'Azur Region, France
Hopital Avicenne
Bobigny, , France
Departement d'Hacpatologie
Clichy, Île-de-France Region, France
Hôpital Saint Antoine
Paris, Île-de-France Region, France
Synexus Clinical Research GmbH, Prüfzentrum Frankfurt
Frankfurt am Main, Hesse, Germany
Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
Marburg, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Gastroenterologische Gemeinschaftspraxis
Herne, Nordhein-Westfalen, Germany
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
Uniklinik Köln
Cologne, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, Germany
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Praxis Driesener Strasse
Berlin, , Germany
Synexus Clinical Research GmbH, Prüfzentrum Berlin
Berlin, , Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, , Germany
Thomopoulos Gastroenterology Dept.
Patra, Peloponnese, Greece
Hippokratio Hospital
Thessaloniki, , Greece
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Shatin, New Territories, Hong Kong
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy County, Hungary
SYNEXUS Magyarország Kft. - Budapest DRS
Budapest, , Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft
Debrecen, , Hungary
EMMS MC
Nazareth, Jerusalem, Israel
Rambam Health Care Campus - Rambam Medical Center
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah Medical Center, Institute of Gastroenterology and Liver Diseases
Jerusalem, , Israel
Galilee Medical Center
Nahariya, , Israel
Rabin Medical Center Beilinson Hospital
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Azienda Ospedaliera Universitaria Careggi SOD Medicina Interna ed Epatologia
Florence, , Italy
ASST Santi Paolo e Carlo
Milan, , Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Fondazione Policlinico Tor Vergata
Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, , Italy
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Consultorio Médico Dr. Alma Laura Ladron de Guevara
Mexico City, Mexico City, Mexico
JM Research - Cuernavaca
Cuernavaca, Morelos, Mexico
Investigaciones Medicas Cisneros
Monterrey, Nuevo León, Mexico
Consultorio Dra. Maria Sarai Gonzalez Huezo
Metepec, , Mexico
Auckland City Hospital
Grafton, Auckland, New Zealand
Middlemore Clinical Trials
Papatoetoe, Auckland, New Zealand
Oslo Universitetssykehus-Ullevål
Oslo, , Norway
Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska
Wroclaw, Lower Silesian Voivodeship, Poland
EMC Instytut Medyczny
Wroclaw, Lower Silesian Voivodeship, Poland
Szpital Specjalistyczny Nr 1 w Bytomiu
Bytom, Silesian Voivodeship, Poland
ID Clinic Arkadiusz Pisula
Mysłowice, Silesian Voivodeship, Poland
Synexus Polska Sp z o o Oddzial w Poznaniu
Poznan, Wielkopolska, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Wroclaw, Poland
Synexus Polska Sp. Z o.o. Oddzial w Czestochowie
Częstochowa, , Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, , Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni ul.
Gdynia, , Poland
Synexus SCM Sp. z o.o. Oddzial
Katowice, , Poland
Synexus Polska Sp. z o.o. Oddział w Warszawie
Warsaw, , Poland
Synexus Polska Sp. z o.o. Oddział w Łodzi
Lodz, Łódź Voivodeship, Poland
Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
Lódz, Łódź Voivodeship, Poland
Presa-Ramos
Vila Real, Lordelo, Portugal
Unidade Local de Saúde do Alto Minho
Viana do Castelo, , Portugal
Clinical Research Puerto Rico
San Juan, PR, Puerto Rico
Fundacion de Investigacion De Diego
San Juan, , Puerto Rico
Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor
Cluj-Napoca, Cluj, Romania
Clinic Professor Gorbakova
Krasnogorsk, Moscow, Russia
Sklifosovsky Scientific Research Institution of Emergency Care
Moscow, , Russia
Moscow Regional Research and Clinical Institute M.F. Vladimirsky
Moscow, , Russia
National University Hospital
Singapore, , Singapore
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Guipuzcoa, Spain
Complejo Hospitalario Torrecardenas
Almería, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Ramón Y Cajal
Madrid, , Spain
Hospital Clínico Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitario Nuestra Senora de Valme
Seville, , Spain
Consorci Hospital General Universitari de València
Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Kantonsspital St.Gallen Klinik für
Sankt Gallen, Canton of St. Gallen, Switzerland
Universitaetsspital Bern Inselspital
Bern, , Switzerland
Chia-Yi Christian Hospital
Chiayi City, Chiayi, Taiwan
China Medical University Hospital
Taichung, Taichung City, Taiwan
Chang Gung Medical Foundation-LinKou Branch
Taoyuan District, , Taiwan
University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, England, United Kingdom
Royal Free London NHS Foundation Trust
London, England, United Kingdom
Kings College Hospital NHS Foundation Trust
London, England, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, England, United Kingdom
Luton and Dunstable Hospital NHS Foundation Trust
Luton, England, United Kingdom
Newcastle Upon the Tyne Hospitals
Newcastle, England, United Kingdom
Nottingham Digestive Diseases Biomedical Research Unit
Nottingham, England, United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, England, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, England, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, United Kingdom
Synexus Hexham Clinical Research Centre
Hexham, , United Kingdom
Synexus Lancashire Clinical Research Centre
Lancaster, , United Kingdom
Barts Health NHS Trust The Royal London Hospital
London, , United Kingdom
University Hospital of South Manchester NHS Foundation Trust
Manchester, , United Kingdom
Countries
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References
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Anstee QM, Neuschwander-Tetri BA, Wai-Sun Wong V, Abdelmalek MF, Rodriguez-Araujo G, Landgren H, Park GS, Bedossa P, Alkhouri N, Tacke F, Sanyal AJ. Cenicriviroc Lacked Efficacy to Treat Liver Fibrosis in Nonalcoholic Steatohepatitis: AURORA Phase III Randomized Study. Clin Gastroenterol Hepatol. 2024 Jan;22(1):124-134.e1. doi: 10.1016/j.cgh.2023.04.003. Epub 2023 Apr 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004566-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1001
Identifier Type: REGISTRY
Identifier Source: secondary_id
3152-301-002
Identifier Type: -
Identifier Source: org_study_id
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