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

NCT03028740 | Terminated Phase 3 Results DMC FDA Drug

• 3 other identifiers: 3152-301-0022016-004566-261001
• Study Type: interventional
• Target: 1,778
• Locations: 27 countries
• Sites: 343

Brief Summary

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.

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (2)

• 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

  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 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 Outcomes (11)

• 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

  Month 12

• Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12

  Month 12

• Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12

  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

  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

  Month 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.

Drug: Placebo

Cenicriviroc 150 mg

EXPERIMENTAL

Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.

Drug: Cenicriviroc

Interventions

Placebo DRUG

Cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.

Placebo

Cenicriviroc DRUG

Cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.

Also known as: CVC

Cenicriviroc 150 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tobira Therapeutics, Inc.: lead

Study Sites (346)

Summit Internal Medicine

Birmingham, Alabama, 35243, United States

Location

Cullman Clinical Trials

Cullman, Alabama, 35055, United States

Location

Digestive Health Specialists of the Southeast

Dothan, Alabama, 36305, United States

Location

Objective GI D/B/A North Alabama GI Research Center

Madison, Alabama, 35758, United States

Location

The Institute for Liver Health

Chandler, Arizona, 85224, United States

Location

Adobe Gastroenterology Research, LLC

Tucson, Arizona, 85712, United States

Location

Del Sol Research Management, LLC

Tucson, Arizona, 85712, United States

Location

Del Sol Research Management LLC

Tucson, Arizona, 85745, United States

Location

Arkansas Diagnostic Center

Little Rock, Arkansas, 72205, United States

Location

Franco Felizarta MD

Bakersfield, California, 93301, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

GW Research

Chula Vista, California, 91910, United States

Location

eStudySite

Chula Vista, California, 91911, United States

Location

Southern California Research Center

Coronado, California, 92118, United States

Location

Citrus Valley Gastroenterology

Covina, California, 91722, United States

Location

TriWest Research Associates

El Cajon, California, 92020, United States

Location

University of San Francisco, Fresno Medical Education Program

Fresno, California, 93701, United States

Location

Fresno Clinical Research Center (FCRC)

Fresno, California, 93720, United States

Location

National Research Institute

Huntington Park, California, 90255, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

eStudySite

La Mesa, California, 91942, United States

Location

Om Research

Lancaster, California, 93534, United States

Location

Southern California Kaiser Permanente, Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

GastroIntestinal Biosciences

Los Angeles, California, 90036, United States

Location

Global Research Institute

Los Angeles, California, 90036, United States

Location

Ruane Medical and Liver Health Institute

Los Angeles, California, 90036, United States

Location

Cedars-Sinai Medical Group

Los Angeles, California, 90048, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

United Medical Doctors

Murrieta, California, 92563, United States

Location

Palmtree Clinical Research Inc.

Palm Springs, California, 92262, United States

Location

National Research Institute

Panorama City, California, 91402, United States

Location

Pasadena Liver Center

Pasadena, California, 91105, United States

Location

Alliance Clinical Research LLC

Poway, California, 92064, United States

Location

Stanford School of Medicine, Center for Clinical Sciences Research

Redwood City, California, 94063, United States

Location

Inland Empire Liver Foundation

Rialto, California, 92377-4697, United States

Location

Precision Research Institute

San Diego, California, 92114, United States

Location

Southern California Permanente Medical Group

San Diego, California, 92154, United States

Location

UCSF School of Medicine

San Francisco, California, 94143-0538, United States

Location

Upland Clinical Research

Upland, California, 91786, United States

Location

Island View GI

Ventura, California, 93003, United States

Location

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

Location

South Denver Gastroenterology, PC

Englewood, Colorado, 80113, United States

Location

Western States Clinical Research, Inc.

Wheat Ridge, Colorado, 80033, United States

Location

Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, 06606, United States

Location

Yale University - New Haven

New Haven, Connecticut, 06511, United States

Location

Innovative Medical Research of South Florida, Inc.

Aventura, Florida, 33180, United States

Location

Gastro Florida

Clearwater, Florida, 33761, United States

Location

Hi Tech and Global Research, LLC

Coral Gables, Florida, 33134, United States

Location

Top Medical Research, Inc

Cutler Bay, Florida, 33189, United States

Location

ICR Sites

Doral, Florida, 33166, United States

Location

Qway Research, LLC

Hialeah, Florida, 33010, United States

Location

Gastroenterology Associates - Crystal River

Inverness, Florida, 34452, United States

Location

Mayo Clinic College of Medicine

Jacksonville, Florida, 32224, United States

Location

Meridien Research

Lakeland, Florida, 33803, United States

Location

Florida Digestive Health Specialists

Lakewood Rch, Florida, 34211, United States

Location

Meridien Research

Maitland, Florida, 32751, United States

Location

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014, United States

Location

Bruce W. Carter Department of Veterans Affairs Medical Center

Miami, Florida, 33125, United States

Location

Optimus U Corporation

Miami, Florida, 33125, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Sanchez Clinical Research, Inc

Miami, Florida, 33157, United States

Location

Genoma Research Group Inc.

Miami, Florida, 33165, United States

Location

Medical Professional Clinical Research Center, INC

Miami, Florida, 33165, United States

Location

ProLive Medical Research

Miami, Florida, 33175, United States

Location

San Marcus Research Clinic

Miami Lakes, Florida, 33014, United States

Location

Advanced Research Institute, Inc.

New Port Richey, Florida, 34653, United States

Location

Bioclinical Research Alliance

Orlando, Florida, 32806, United States

Location

Omega Research Maitland, LLC

Orlando, Florida, 32810, United States

Location

IMIC, Inc

Palmetto Bay, Florida, 33157, United States

Location

Innovation Medical Research Center

Palmetto Bay, Florida, 33157, United States

Location

Gastroenterology Associates of Pensacola

Pensacola, Florida, 32503, United States

Location

Advanced Medical Research

Port Orange, Florida, 32127, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Guardian Angel Research Center

Tampa, Florida, 33614, United States

Location

Bioclinica Research

The Villages, Florida, 32162, United States

Location

Florida Medical Clinic

Zephyrhills, Florida, 33542, United States

Location

Summit Clinical Research, LLC

Athens, Georgia, 30607, United States

Location

Digestive Healthcare of Georgia - Atlanta

Atlanta, Georgia, 30309, United States

Location

Piedmont Healthcare INC.

Atlanta, Georgia, 30309, United States

Location

Gastroenterology Associates of Central Georgia

Macon, Georgia, 31201, United States

Location

GI Specialists of Georgia - Marietta Office

Marietta, Georgia, 30060, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Investigators Research Group, LLC

Brownsburg, Indiana, 46112, United States

Location

Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, 46237, United States

Location

Aquiant Research

New Albany, Indiana, 47150, United States

Location

Digestive Research Alliance of Michiana

South Bend, Indiana, 46635, United States

Location

Iowa Digestive Disease Center

Clive, Iowa, 50325, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kansas Medical Clinic-Gastroenterology

Topeka, Kansas, 66606, United States

Location

Delta Research Partners, LLC

Bastrop, Louisiana, 71220, United States

Location

Avant Research Associates LLC

Crowley, Louisiana, 70526, United States

Location

C-1 Headlands, Inc.

Lake Charles, Louisiana, 70601, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Nola Research Works, LLC

New Orleans, Louisiana, 70125, United States

Location

Louisiana Research Center

Shreveport, Louisiana, 71105, United States

Location

Clinical Trials of America LLC

West Monroe, Louisiana, 71291, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Digestive Disease Associates

Catonsville, Maryland, 21228, United States

Location

Gastro Center of Maryland

Columbia, Maryland, 21045, United States

Location

Woodholme Gastroenterology Associates

Glen Burnie, Maryland, 21061, United States

Location

Victory Clinical Research

Greenbelt, Maryland, 20770, United States

Location

Meritus Center for Clinical Research

Hagerstown, Maryland, 21742, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Umass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Minnesota Gastroenterology, P.A.

Maplewood, Minnesota, 55117, United States

Location

National Diabetes and Obesity Research Institute

Biloxi, Mississippi, 39532, United States

Location

GastroIntestinal Associates

Flowood, Mississippi, 39232, United States

Location

Clinical Research Professionals

Chesterfield, Missouri, 63005, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Machuca Family Medicine

Las Vegas, Nevada, 89104, United States

Location

Jubilee Clinical Research, Inc.

Las Vegas, Nevada, 89106, United States

Location

Sierra Clinical Research

Las Vegas, Nevada, 89106, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Amici Clinical Research

Raritan, New Jersey, 08869, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

NYU Langone Health - Perlmutter Cancer Center

New York, New York, 10016, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Tandem Clinical Research

New York, New York, 10033, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Investigational Drug Service, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Northeast GI Research Division

Concord, North Carolina, 28027, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cumberland Research Associates, LLC

Fayetteville, North Carolina, 28304, United States

Location

Carolina Research

Greenville, North Carolina, 27834, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Consultants for Clinical Research

Cincinnati, Ohio, 45249, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

The Ohio University - Gastroenterology, Hepatology

Columbus, Ohio, 43210, United States

Location

Digestive Disease Specialist, Inc.

Oklahoma City, Oklahoma, 73112, United States

Location

Options Health Research

Tulsa, Oklahoma, 74104, United States

Location

Eastern Pennsylvania Gastroenterology and Liver Specialist

Bethlehem, Pennsylvania, 18017, United States

Location

UPMC -Center for Liver Diseases

Pittsburgh, Pennsylvania, 15213, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Care Access Research, Pottsville

Pottsville, Pennsylvania, 17901, United States

Location

Digestive Disease Associates, LTD

Wyomissing, Pennsylvania, 19610, United States

Location

Partners in Clinical Research

Cumberland, Rhode Island, 02864, United States

Location

University Medical Group

North Providence, Rhode Island, 02908, United States

Location

Care Access Research-Warwick

Warwick, Rhode Island, 02886, United States

Location

Rapid City Medical Center

Rapid City, South Dakota, 57701, United States

Location

Mount Vernon Clinical Research

Chattanooga, Tennessee, 37421, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Digestive Health Research

Hermitage, Tennessee, 37076, United States

Location

East Tennessee Research Institute

Johnson City, Tennessee, 37604, United States

Location

Digestive Health Research

Lebanon, Tennessee, 37090, United States

Location

UT-Memphis, Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-1610, United States

Location

Texas Clinical Research Institute

Arlington, Texas, 76012, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Liver Center of Texas

Dallas, Texas, 75234, United States

Location

Synexus

Dallas, Texas, 75234, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

San Antonio Military Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Baylor Scott & White All Saints Medical Center - Ft. Worth

Fort Worth, Texas, 76104, United States

Location

Texas Digestive Disease Consultants - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Digestive Health Associates of Texas-Rockwall

Garland, Texas, 75044, United States

Location

Therapeutic Concepts, PA

Houston, Texas, 77004, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, 77009, United States

Location

Liver Associates of Texas

Houston, Texas, 77030-3002, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Michael E. DeBakey VA Medical Center (MEDVAMC)

Houston, Texas, 77030, United States

Location

St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77043, United States

Location

Centex Studies

Houston, Texas, 77058, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77084, United States

Location

Amir Ali Hassan, MD, PA

Houston, Texas, 77089, United States

Location

Centex Studies, Inc.

McAllen, Texas, 78504, United States

Location

LinQ Research, LLC

Pearland, Texas, 77584, United States

Location

Quality Research Inc.

San Antonio, Texas, 78209, United States

Location

American Research Corporation

San Antonio, Texas, 78215, United States

Location

Clinical Trials of Texas Inc

San Antonio, Texas, 78229, United States

Location

Diabetes & Glandular Disease Clinic, P.A. (DGD)

San Antonio, Texas, 78229, United States

Location

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78229, United States

Location

Southern Star Research Institute, LLC SAGACT PLLC.

San Antonio, Texas, 78229, United States

Location

Anson Medicine

San Antonio, Texas, 78260, United States

Location

Mount Olympus Medical Research, LLC

Sugar Land, Texas, 77479, United States

Location

Texas Digestive Disease Consultants

Webster, Texas, 77598, United States

Location

Physician's Research Options, LLC

Draper, Utah, 84020, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Advanced Clinical Research - Center for Digestive Health

Riverton, Utah, 84065, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Gastroenterology Associates of Northern Virginia

Fairfax, Virginia, 22031, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Liver Institute of Virginia

Newport News, Virginia, 23602, United States

Location

Digestive and Liver Disease Specialists

Norfolk, Virginia, 23502, United States

Location

McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

VCU Medical Center

Richmond, Virginia, 23298, United States

Location

Gastroenterology Consultants of Southwest Virginia Research

Roanoke, Virginia, 24014, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Liver Institute Northwest

Seattle, Washington, 98105, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Marshall University Joan C. Edwards School of Medicine

Huntington, West Virginia, 25701, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Saint George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Center

Adelaide, South Australia, 5042, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Universitatsklinik far Innere Medizin

Graz, Styria, 8036, Austria

Location

Universitatsklinik far Innere Medizin II

Innsbruck, Tyrol, 6020, Austria

Location

Klinikum Wels-Grieskirchen

Wels, Upper Austria, 4600, Austria

Location

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, 2650, Belgium

Location

Hôpital Erasme

Brussels, Brussels Capital, 1070, Belgium

Location

Algemeen Ziekenhuis Maria Middelares

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Centre Hospitalier Chretien CHC

Liège, 4000, Belgium

Location

Hospital das Clínicas da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Faculdade de Medicina de São José do Rio Preto Hospital de Base

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, 21941-913, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-000, Brazil

Location

University of Calgary Liver Unit

Calgary, Alberta, T2N 4Z6, Canada

Location

Bailey Health Clinic

Edmonton, Alberta, T5H 4B9, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

William Osler Health Centre, Brampton Memorial Hospital Campus

Brampton, Ontario, L6R 3J7, Canada

Location

Toronto Liver Centre

Toronto, Ontario, M6H 3M1, Canada

Location

Ecogene-21

Chicoutimi, Quebec, G7H 7K9, Canada

Location

Centro de Investigaciones Clínicas Viña del Mar

Viña del Mar, Región de Valparaíso, 2540488, Chile

Location

CHU de Strasbourg

Strasbourg, Alsace, 67091, France

Location

CHU De Bordeaux - Hôpital Haût-Lévèque CMC Magellan Unita de Recherche Clinique

Pessac, Aquitaine, 33604, France

Location

Centre Hospitalier Universitaire Estaing

Clermont-Ferrand, Aubergne, 63003, France

Location

Centre Hospitalier Universitaire Grenoble

Grenoble, Auvergne-Rhône-Alpes, 38700, France

Location

Centre Hospitalier Universitaire de Rennes- Hôpital Pontchaillou

Rennes, Brittany Region, 35033, France

Location

Centre Hospitalier Regional et Universitaire de Besancon - L'Hopital Jean Minjoz

Besançon, Franche-Comte, 25030, France

Location

CHU de Montpellier

Montpellier, Languedoc-Roussillon, 34295, France

Location

Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle

Rouen, Normandy, 76000, France

Location

Center Hospitalier Universitaire d'Angers

Angers, Pays de la Loire Region, 49000, France

Location

Hapital Sud Service d'Hepato- Gastroentarologie

Amiens, Picardie, 80054, France

Location

Centre Hospitalier Universitaire de Nice Hôpital l'Archet

Nice, Provence-Alpes-Côte d'Azur Region, 06202, France

Location

Hopital Avicenne

Bobigny, 93000, France

Location

Departement d'Hacpatologie

Clichy, Île-de-France Region, 92110, France

Location

Hôpital Saint Antoine

Paris, Île-de-France Region, 75571, France

Location

Synexus Clinical Research GmbH, Prüfzentrum Frankfurt

Frankfurt am Main, Hesse, 60313, Germany

Location

Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH

Marburg, Hesse, 35043, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Gastroenterologische Gemeinschaftspraxis

Herne, Nordhein-Westfalen, 44623, Germany

Location

Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Uniklinik Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, Saarland, 66427, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Praxis Driesener Strasse

Berlin, 10439, Germany

Location

Synexus Clinical Research GmbH, Prüfzentrum Berlin

Berlin, 12627, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Thomopoulos Gastroenterology Dept.

Patra, Peloponnese, 26504, Greece

Location

Hippokratio Hospital

Thessaloniki, 54642, Greece

Location

Prince of Wales Hospital

Shatin, New Territories, 00852, Hong Kong

Location

Alice Ho Miu Ling Nethersole Hospital

Shatin, New Territories, Hong Kong

Location

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, Somogy County, 7400-7400, Hungary

Location

SYNEXUS Magyarország Kft. - Budapest DRS

Budapest, 1036, Hungary

Location

Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

Debrecen, 4025, Hungary

Location

EMMS MC

Nazareth, Jerusalem, 91031, Israel

Location

Rambam Health Care Campus - Rambam Medical Center

Haifa, 31999, Israel

Location

Carmel Medical Center

Haifa, 34362, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Hadassah Medical Center, Institute of Gastroenterology and Liver Diseases

Jerusalem, 91120, Israel

Location

Galilee Medical Center

Nahariya, 22100, Israel

Location

Rabin Medical Center Beilinson Hospital

Petah Tikva, 49100, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milano, 20162, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliera Universitaria Careggi SOD Medicina Interna ed Epatologia

Florence, 50134, Italy

Location

ASST Santi Paolo e Carlo

Milan, 20142, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Fondazione Policlinico Tor Vergata

Roma, 00133, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Pauls Stradins Clinical University Hospital

Riga, LV-1002-1002, Latvia

Location

Consultorio Médico Dr. Alma Laura Ladron de Guevara

Mexico City, Mexico City, 06700, Mexico

Location

JM Research - Cuernavaca

Cuernavaca, Morelos, 62290, Mexico

Location

Investigaciones Medicas Cisneros

Monterrey, Nuevo León, 64000, Mexico

Location

Consultorio Dra. Maria Sarai Gonzalez Huezo

Metepec, 52140, Mexico

Location

Auckland City Hospital

Grafton, Auckland, 1023, New Zealand

Location

Middlemore Clinical Trials

Papatoetoe, Auckland, 2025, New Zealand

Location

Oslo Universitetssykehus-Ullevål

Oslo, 0450, Norway

Location

Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska

Wroclaw, Lower Silesian Voivodeship, 51-162, Poland

Location

EMC Instytut Medyczny

Wroclaw, Lower Silesian Voivodeship, 54-144, Poland

Location

Szpital Specjalistyczny Nr 1 w Bytomiu

Bytom, Silesian Voivodeship, 41-902, Poland

Location

ID Clinic Arkadiusz Pisula

Mysłowice, Silesian Voivodeship, 41400-400, Poland

Location

Synexus Polska Sp z o o Oddzial w Poznaniu

Poznan, Wielkopolska, 60 702-702, Poland

Location

Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroclaw, Wroclaw, 50-381, Poland

Location

Synexus Polska Sp. Z o.o. Oddzial w Czestochowie

Częstochowa, 0 42-202, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, 80-382, Poland

Location

Synexus Polska Sp. z o.o. Oddzial w Gdyni ul.

Gdynia, 81-537, Poland

Location

Synexus SCM Sp. z o.o. Oddzial

Katowice, 40-040, Poland

Location

Synexus Polska Sp. z o.o. Oddział w Warszawie

Warsaw, 01-192, Poland

Location

Synexus Polska Sp. z o.o. Oddział w Łodzi

Lodz, Łódź Voivodeship, 90-127, Poland

Location

Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi

Lódz, Łódź Voivodeship, 91-347, Poland

Location

Presa-Ramos

Vila Real, Lordelo, 5000-508, Portugal

Location

Unidade Local de Saúde do Alto Minho

Viana do Castelo, 4904-858, Portugal

Location

Clinical Research Puerto Rico

San Juan, PR, 00909-1711, Puerto Rico

Location

Fundacion de Investigacion De Diego

San Juan, 00927, Puerto Rico

Location

Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor

Cluj-Napoca, Cluj, 400162, Romania

Location

Clinic Professor Gorbakova

Krasnogorsk, Moscow, 143405, Russia

Location

Sklifosovsky Scientific Research Institution of Emergency Care

Moscow, 129090, Russia

Location

Moscow Regional Research and Clinical Institute M.F. Vladimirsky

Moscow, 129110, Russia

Location

National University Hospital

Singapore, 119082, Singapore

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Donostia

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

Location

Complejo Hospitalario Torrecardenas

Almería, 4009, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario Ramón Y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital Universitario Nuestra Senora de Valme

Seville, 41014, Spain

Location

Consorci Hospital General Universitari de València

Valencia, 46014, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Kantonsspital St.Gallen Klinik für

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Universitaetsspital Bern Inselspital

Bern, 3010, Switzerland

Location

Chia-Yi Christian Hospital

Chiayi City, Chiayi, 60002, Taiwan

Location

China Medical University Hospital

Taichung, Taichung City, 404, Taiwan

Location

Chang Gung Medical Foundation-LinKou Branch

Taoyuan District, 333, Taiwan

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Hull and East Yorkshire Hospitals NHS Trust

Hull, England, HU3 2JZ, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, England, NW3 2QG, United Kingdom

Location

Kings College Hospital NHS Foundation Trust

London, England, SE5 9RS, United Kingdom

Location

Chelsea and Westminster Hospital NHS Foundation Trust

London, England, SW10 9NH, United Kingdom

Location

Luton and Dunstable Hospital NHS Foundation Trust

Luton, England, LU4 0DZ, United Kingdom

Location

Newcastle Upon the Tyne Hospitals

Newcastle, England, NE2 7DN, United Kingdom

Location

Nottingham Digestive Diseases Biomedical Research Unit

Nottingham, England, NG7 2UH, United Kingdom

Location

Plymouth Hospitals NHS Trust

Plymouth, England, PL6 8DH, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, England, ST4 6QG, United Kingdom

Location

St James's University Hospital

Leeds, West Yorkshire, LS97TF, United Kingdom

Location

Synexus Hexham Clinical Research Centre

Hexham, NE46 1QJ, United Kingdom

Location

Synexus Lancashire Clinical Research Centre

Lancaster, PR7 7NA, United Kingdom

Location

Barts Health NHS Trust The Royal London Hospital

London, E1 1BB, United Kingdom

Location

University Hospital of South Manchester NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37061109 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

cenicriviroc

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Gerardo Rodriguez

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 23, 2017
• Study Start: April 5, 2017
• Primary Completion: January 12, 2021
• Study Completion: March 9, 2021
• Last Updated: March 10, 2022
• Results First Posted: March 10, 2022

Record last verified: 2021-11

Locations

RO (1); SG (1); CH (2); BE (6); HU (3); GR (2); PT (2); PR (2); IT (8); TW (3); FR (14); ES (13); GB (15); NO (1); DE (13); LA (1); ME (4); BR (4); CA (6); RU (3); NZ (2); US (204); AU (8); CL (1); HK (2); IL (9); PL (13)