AzTrials
AzTrials

Nonalcoholic SteatohepatitisPhase 3AURORANCT03028740

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

A Phase 3 study testing Cenicriviroc in people with Nonalcoholic Steatohepatitis, run by Tobira Therapeutics, Inc. at 346 sites in 28 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nonalcoholic Steatohepatitis
What is being tested?
Cenicriviroc
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,778 participants
Where
346 sitesin 28 countries
Study dates
5 Apr 2017to 9 Mar 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 24Show fewer
  • 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).

Trial locations and contacts

346 sites in 28 countries.

346 sites in 28 countries

United States204 sites

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Summit Clinical Research, LLC

    Athens, Georgia, 30607

  • Digestive Healthcare of Georgia - Atlanta

    Atlanta, Georgia, 30309

  • Piedmont Healthcare INC.

    Atlanta, Georgia, 30309

  • Innovative Medical Research of South Florida, Inc.

    Aventura, Florida, 33180

  • Franco Felizarta MD

    Bakersfield, California, 93301

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Delta Research Partners, LLC

    Bastrop, Louisiana, 71220

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Eastern Pennsylvania Gastroenterology and Liver Specialist

    Bethlehem, Pennsylvania, 18017

  • National Diabetes and Obesity Research Institute

    Biloxi, Mississippi, 39532

  • Summit Internal Medicine

    Birmingham, Alabama, 35243

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606

  • Investigators Research Group, LLC

    Brownsburg, Indiana, 46112

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Digestive Disease Associates

    Catonsville, Maryland, 21228

  • The Institute for Liver Health

    Chandler, Arizona, 85224

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

    Chapel Hill, North Carolina, 27514

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • Mount Vernon Clinical Research

    Chattanooga, Tennessee, 37421

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • GW Research

    Chula Vista, California, 91910

  • eStudySite

    Chula Vista, California, 91911

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45249

  • Gastro Florida

    Clearwater, Florida, 33761

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • The Ohio University - Gastroenterology, Hepatology

    Columbus, Ohio, 43210

  • Northeast GI Research Division

    Concord, North Carolina, 28027

  • Hi Tech and Global Research, LLC

    Coral Gables, Florida, 33134

  • Southern California Research Center

    Coronado, California, 92118

  • Citrus Valley Gastroenterology

    Covina, California, 91722

  • Avant Research Associates LLC

    Crowley, Louisiana, 70526

  • Cullman Clinical Trials

    Cullman, Alabama, 35055

  • Partners in Clinical Research

    Cumberland, Rhode Island, 02864

  • Top Medical Research, Inc

    Cutler Bay, Florida, 33189

  • Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • Liver Center of Texas

    Dallas, Texas, 75234

  • Synexus

    Dallas, Texas, 75234

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • ICR Sites

    Doral, Florida, 33166

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Physician's Research Options, LLC

    Draper, Utah, 84020

  • Duke University

    Durham, North Carolina, 27710

  • TriWest Research Associates

    El Cajon, California, 92020

  • South Denver Gastroenterology, PC

    Englewood, Colorado, 80113

  • Gastroenterology Associates of Northern Virginia

    Fairfax, Virginia, 22031

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • GastroIntestinal Associates

    Flowood, Mississippi, 39232

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78234

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

    Fort Worth, Texas, 76104

  • Texas Digestive Disease Consultants - Fort Worth

    Fort Worth, Texas, 76104

  • University of San Francisco, Fresno Medical Education Program

    Fresno, California, 93701

  • Fresno Clinical Research Center (FCRC)

    Fresno, California, 93720

  • Digestive Health Associates of Texas-Rockwall

    Garland, Texas, 75044

  • Gastro One

    Germantown, Tennessee, 38138

  • Woodholme Gastroenterology Associates

    Glen Burnie, Maryland, 21061

  • Victory Clinical Research

    Greenbelt, Maryland, 20770

  • Carolina Research

    Greenville, North Carolina, 27834

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Digestive Health Research

    Hermitage, Tennessee, 37076

  • Qway Research, LLC

    Hialeah, Florida, 33010

  • Therapeutic Concepts, PA

    Houston, Texas, 77004

  • Pioneer Research Solutions, Inc.

    Houston, Texas, 77009

  • Liver Associates of Texas

    Houston, Texas, 77030-3002

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Michael E. DeBakey VA Medical Center (MEDVAMC)

    Houston, Texas, 77030

  • St. Luke's Medical Center

    Houston, Texas, 77030

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Centex Studies

    Houston, Texas, 77058

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Amir Ali Hassan, MD, PA

    Houston, Texas, 77089

  • Marshall University Joan C. Edwards School of Medicine

    Huntington, West Virginia, 25701

  • National Research Institute

    Huntington Park, California, 90255

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana, 46237

  • Gastroenterology Associates - Crystal River

    Inverness, Florida, 34452

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Mayo Clinic College of Medicine

    Jacksonville, Florida, 32224

  • East Tennessee Research Institute

    Johnson City, Tennessee, 37604

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of California San Diego

    La Jolla, California, 92037

  • eStudySite

    La Mesa, California, 91942

  • C-1 Headlands, Inc.

    Lake Charles, Louisiana, 70601

  • Meridien Research

    Lakeland, Florida, 33803

  • Florida Digestive Health Specialists

    Lakewood Rch, Florida, 34211

  • Om Research

    Lancaster, California, 93534

  • Machuca Family Medicine

    Las Vegas, Nevada, 89104

  • Jubilee Clinical Research, Inc.

    Las Vegas, Nevada, 89106

  • Sierra Clinical Research

    Las Vegas, Nevada, 89106

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Digestive Health Research

    Lebanon, Tennessee, 37090

  • Arkansas Diagnostic Center

    Little Rock, Arkansas, 72205

  • Southern California Kaiser Permanente, Los Angeles Medical Center

    Los Angeles, California, 90027

  • GastroIntestinal Biosciences

    Los Angeles, California, 90036

  • Global Research Institute

    Los Angeles, California, 90036

  • Ruane Medical and Liver Health Institute

    Los Angeles, California, 90036

  • Cedars-Sinai Medical Group

    Los Angeles, California, 90048

  • National Research Institute

    Los Angeles, California, 90057

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

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

    Madison, Alabama, 35758

  • Meridien Research

    Maitland, Florida, 32751

  • Minnesota Gastroenterology, P.A.

    Maplewood, Minnesota, 55117

  • GI Specialists of Georgia - Marietta Office

    Marietta, Georgia, 30060

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Centex Studies, Inc.

    McAllen, Texas, 78504

  • UT-Memphis, Methodist University Hospital

    Memphis, Tennessee, 38104

  • Clinical Pharmacology of Miami, LLC

    Miami, Florida, 33014

  • Bruce W. Carter Department of Veterans Affairs Medical Center

    Miami, Florida, 33125

  • Optimus U Corporation

    Miami, Florida, 33125

  • University of Miami Hospital

    Miami, Florida, 33136

  • Sanchez Clinical Research, Inc

    Miami, Florida, 33157

  • Genoma Research Group Inc.

    Miami, Florida, 33165

  • Medical Professional Clinical Research Center, INC

    Miami, Florida, 33165

  • ProLive Medical Research

    Miami, Florida, 33175

  • San Marcus Research Clinic

    Miami Lakes, Florida, 33014

  • Intermountain Medical Center

    Murray, Utah, 84107

  • United Medical Doctors

    Murrieta, California, 92563

  • Vanderbilt University

    Nashville, Tennessee, 37232-1610

  • Aquiant Research

    New Albany, Indiana, 47150

  • Yale University - New Haven

    New Haven, Connecticut, 06511

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Nola Research Works, LLC

    New Orleans, Louisiana, 70125

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34653

  • Beth Israel Medical Center

    New York, New York, 10003

  • NYU Langone Health - Perlmutter Cancer Center

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Tandem Clinical Research

    New York, New York, 10033

  • Weill Cornell Medical College

    New York, New York, 10065

  • Liver Institute of Virginia

    Newport News, Virginia, 23602

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • University Medical Group

    North Providence, Rhode Island, 02908

  • Digestive Disease Specialist, Inc.

    Oklahoma City, Oklahoma, 73112

  • Bioclinical Research Alliance

    Orlando, Florida, 32806

  • Omega Research Maitland, LLC

    Orlando, Florida, 32810

  • Palmtree Clinical Research Inc.

    Palm Springs, California, 92262

  • IMIC, Inc

    Palmetto Bay, Florida, 33157

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • National Research Institute

    Panorama City, California, 91402

  • Pasadena Liver Center

    Pasadena, California, 91105

  • LinQ Research, LLC

    Pearland, Texas, 77584

  • Gastroenterology Associates of Pensacola

    Pensacola, Florida, 32503

  • UPMC -Center for Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • Advanced Medical Research

    Port Orange, Florida, 32127

  • Care Access Research, Pottsville

    Pottsville, Pennsylvania, 17901

  • Alliance Clinical Research LLC

    Poway, California, 92064

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Rapid City Medical Center

    Rapid City, South Dakota, 57701

  • Amici Clinical Research

    Raritan, New Jersey, 08869

  • Stanford School of Medicine, Center for Clinical Sciences Research

    Redwood City, California, 94063

  • Inland Empire Liver Foundation

    Rialto, California, 92377-4697

  • McGuire Veterans Affairs Medical Center

    Richmond, Virginia, 23249

  • VCU Medical Center

    Richmond, Virginia, 23298

  • Advanced Clinical Research - Center for Digestive Health

    Riverton, Utah, 84065

  • Gastroenterology Consultants of Southwest Virginia Research

    Roanoke, Virginia, 24014

  • University of Utah

    Salt Lake City, Utah, 84132

  • Quality Research Inc.

    San Antonio, Texas, 78209

  • American Research Corporation

    San Antonio, Texas, 78215

  • Clinical Trials of Texas Inc

    San Antonio, Texas, 78229

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

    San Antonio, Texas, 78229

  • Endeavor Clinical Trials, LLC

    San Antonio, Texas, 78229

  • Southern Star Research Institute, LLC SAGACT PLLC.

    San Antonio, Texas, 78229

  • Anson Medicine

    San Antonio, Texas, 78260

  • Precision Research Institute

    San Diego, California, 92114

  • Southern California Permanente Medical Group

    San Diego, California, 92154

  • UCSF School of Medicine

    San Francisco, California, 94143-0538

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Liver Institute Northwest

    Seattle, Washington, 98105

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Louisiana Research Center

    Shreveport, Louisiana, 71105

  • Digestive Research Alliance of Michiana

    South Bend, Indiana, 46635

  • Saint Louis University

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Mount Olympus Medical Research, LLC

    Sugar Land, Texas, 77479

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Guardian Angel Research Center

    Tampa, Florida, 33614

  • Bioclinica Research

    The Villages, Florida, 32162

  • Kansas Medical Clinic-Gastroenterology

    Topeka, Kansas, 66606

  • Adobe Gastroenterology Research, LLC

    Tucson, Arizona, 85712

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85712

  • Del Sol Research Management LLC

    Tucson, Arizona, 85745

  • Options Health Research

    Tulsa, Oklahoma, 74104

  • Upland Clinical Research

    Upland, California, 91786

  • Island View GI

    Ventura, California, 93003

  • Care Access Research-Warwick

    Warwick, Rhode Island, 02886

  • Texas Digestive Disease Consultants

    Webster, Texas, 77598

  • Clinical Trials of America LLC

    West Monroe, Louisiana, 71291

  • Western States Clinical Research, Inc.

    Wheat Ridge, Colorado, 80033

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Umass Memorial Medical Center

    Worcester, Massachusetts, 01655

  • Digestive Disease Associates, LTD

    Wyomissing, Pennsylvania, 19610

  • Florida Medical Clinic

    Zephyrhills, Florida, 33542

Other trials in United States

United Kingdom15 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, England, B15 2TH

  • Synexus Hexham Clinical Research Centre

    Hexham, NE46 1QJ

  • Hull and East Yorkshire Hospitals NHS Trust

    Hull, England, HU3 2JZ

  • Synexus Lancashire Clinical Research Centre

    Lancaster, PR7 7NA

  • St James's University Hospital

    Leeds, West Yorkshire, LS97TF

  • Royal Free London NHS Foundation Trust

    London, England, NW3 2QG

  • Kings College Hospital NHS Foundation Trust

    London, England, SE5 9RS

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, England, SW10 9NH

  • Barts Health NHS Trust The Royal London Hospital

    London, E1 1BB

  • Luton and Dunstable Hospital NHS Foundation Trust

    Luton, England, LU4 0DZ

  • University Hospital of South Manchester NHS Foundation Trust

    Manchester, M23 9LT

  • Newcastle Upon the Tyne Hospitals

    Newcastle, England, NE2 7DN

  • Nottingham Digestive Diseases Biomedical Research Unit

    Nottingham, England, NG7 2UH

  • Plymouth Hospitals NHS Trust

    Plymouth, England, PL6 8DH

  • Royal Stoke University Hospital

    Stoke-on-Trent, England, ST4 6QG

Other trials in United Kingdom

France14 sites

  • Hapital Sud Service d'Hepato- Gastroentarologie

    Amiens, Picardie, 80054

  • Center Hospitalier Universitaire d'Angers

    Angers, Pays de la Loire Region, 49000

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

    Besançon, Franche-Comte, 25030

  • Hopital Avicenne

    Bobigny, 93000

  • Centre Hospitalier Universitaire Estaing

    Clermont-Ferrand, Aubergne, 63003

  • Departement d'Hacpatologie

    Clichy, Île-de-France Region, 92110

  • Centre Hospitalier Universitaire Grenoble

    Grenoble, Auvergne-Rhône-Alpes, 38700

  • CHU de Montpellier

    Montpellier, Languedoc-Roussillon, 34295

  • Centre Hospitalier Universitaire de Nice Hôpital l'Archet

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

  • Hôpital Saint Antoine

    Paris, Île-de-France Region, 75571

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

    Pessac, Aquitaine, 33604

  • Centre Hospitalier Universitaire de Rennes- Hôpital Pontchaillou

    Rennes, Brittany Region, 35033

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

    Rouen, Normandy, 76000

  • CHU de Strasbourg

    Strasbourg, Alsace, 67091

Other trials in France

Germany13 sites

  • Uniklinik RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Praxis Driesener Strasse

    Berlin, 10439

  • Synexus Clinical Research GmbH, Prüfzentrum Berlin

    Berlin, 12627

  • Charité Universitätsmedizin Berlin

    Berlin, 13353

  • Uniklinik Köln

    Cologne, North Rhine-Westphalia, 50937

  • Synexus Clinical Research GmbH, Prüfzentrum Frankfurt

    Frankfurt am Main, Hesse, 60313

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Gastroenterologische Gemeinschaftspraxis

    Herne, Nordhein-Westfalen, 44623

  • Universitätsklinikum des Saarlandes

    Homburg, Saarland, 66427

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH

    Marburg, Hesse, 35043

Other trials in Germany

Poland13 sites

  • Szpital Specjalistyczny Nr 1 w Bytomiu

    Bytom, Silesian Voivodeship, 41-902

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

    Częstochowa, 0 42-202

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

    Gdansk, 80-382

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

    Gdynia, 81-537

  • Synexus SCM Sp. z o.o. Oddzial

    Katowice, 40-040

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

    Lodz, Łódź Voivodeship, 90-127

  • Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi

    Lódz, Łódź Voivodeship, 91-347

  • ID Clinic Arkadiusz Pisula

    Mysłowice, Silesian Voivodeship, 41400-400

  • Synexus Polska Sp z o o Oddzial w Poznaniu

    Poznan, Wielkopolska, 60 702-702

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

    Warsaw, 01-192

  • Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska

    Wroclaw, Lower Silesian Voivodeship, 51-162

  • EMC Instytut Medyczny

    Wroclaw, Lower Silesian Voivodeship, 54-144

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

    Wroclaw, Wroclaw, 50-381

Other trials in Poland

Spain13 sites

  • Complejo Hospitalario Torrecardenas

    Almería, 4009

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario Ramón Y Cajal

    Madrid, 28034

  • Hospital Clínico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Nuestra Senora de Valme

    Seville, 41014

  • Consorci Hospital General Universitari de València

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Israel9 sites

  • Rambam Health Care Campus - Rambam Medical Center

    Haifa, 31999

  • Carmel Medical Center

    Haifa, 34362

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Medical Center, Institute of Gastroenterology and Liver Diseases

    Jerusalem, 91120

  • Galilee Medical Center

    Nahariya, 22100

  • EMMS MC

    Nazareth, Jerusalem, 91031

  • Rabin Medical Center Beilinson Hospital

    Petah Tikva, 49100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Center

    Adelaide, South Australia, 5042

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Saint George Hospital

    Kogarah, New South Wales, 2217

  • Royal Perth Hospital

    Perth, Western Australia, 6000

Other trials in Australia

Italy8 sites

  • Azienda Ospedaliera Universitaria Careggi SOD Medicina Interna ed Epatologia

    Florence, 50134

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Milano, 20162

  • ASST Santi Paolo e Carlo

    Milan, 20142

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Fondazione Policlinico Tor Vergata

    Roma, 00133

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

Other trials in Italy

Belgium6 sites

  • Hôpital Erasme

    Brussels, Brussels Capital, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, Antwerpen, 2650

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000

  • Centre Hospitalier Chretien CHC

    Liège, 4000

Other trials in Belgium

Canada6 sites

  • William Osler Health Centre, Brampton Memorial Hospital Campus

    Brampton, Ontario, L6R 3J7

  • University of Calgary Liver Unit

    Calgary, Alberta, T2N 4Z6

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Bailey Health Clinic

    Edmonton, Alberta, T5H 4B9

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Brazil4 sites

  • Hospital das Clínicas da Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-100

  • Hospital Universitário Clementino Fraga Filho

    Rio de Janeiro, 21941-913

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

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

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

    São Paulo, 05403-000

Other trials in Brazil

Mexico4 sites

  • JM Research - Cuernavaca

    Cuernavaca, Morelos, 62290

  • Consultorio Dra. Maria Sarai Gonzalez Huezo

    Metepec, 52140

  • Consultorio Médico Dr. Alma Laura Ladron de Guevara

    Mexico City, Mexico City, 06700

  • Investigaciones Medicas Cisneros

    Monterrey, Nuevo León, 64000

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Austria3 sites

  • Universitatsklinik far Innere Medizin

    Graz, Styria, 8036

  • Universitatsklinik far Innere Medizin II

    Innsbruck, Tyrol, 6020

  • Klinikum Wels-Grieskirchen

    Wels, Upper Austria, 4600

Other trials in Austria

Hungary3 sites

  • SYNEXUS Magyarország Kft. - Budapest DRS

    Budapest, 1036

  • Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

    Debrecen, 4025

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, Somogy County, 7400-7400

Other trials in Hungary

Russia3 sites

  • Clinic Professor Gorbakova

    Krasnogorsk, Moscow, 143405

  • Sklifosovsky Scientific Research Institution of Emergency Care

    Moscow, 129090

  • Moscow Regional Research and Clinical Institute M.F. Vladimirsky

    Moscow, 129110

Other trials in Russia

Taiwan3 sites

  • Chia-Yi Christian Hospital

    Chiayi City, Chiayi, 60002

  • China Medical University Hospital

    Taichung, Taichung City, 404

  • Chang Gung Medical Foundation-LinKou Branch

    Taoyuan, 333

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Greece2 sites

  • Thomopoulos Gastroenterology Dept.

    Patra, Peloponnese, 26504

  • Hippokratio Hospital

    Thessaloniki, 54642

Other trials in Greece

Hong Kong2 sites

  • Prince of Wales Hospital

    Shatin, New Territories, 00852

  • Alice Ho Miu Ling Nethersole Hospital

    Shatin, New Territories

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New Zealand2 sites

  • Auckland City Hospital

    Grafton, Auckland, 1023

  • Middlemore Clinical Trials

    Papatoetoe, Auckland, 2025

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Portugal2 sites

  • Unidade Local de Saúde do Alto Minho

    Viana do Castelo, 4904-858

  • Presa-Ramos

    Vila Real, Lordelo, 5000-508

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Puerto Rico2 sites

  • Clinical Research Puerto Rico

    San Juan, PR, 00909-1711

  • Fundacion de Investigacion De Diego

    San Juan, 00927

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Switzerland2 sites

  • Universitaetsspital Bern Inselspital

    Bern, 3010

  • Kantonsspital St.Gallen Klinik für

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Chile1 site

  • Centro de Investigaciones Clínicas Viña del Mar

    Viña del Mar, Valparaiso, 2540488

Other trials in Chile

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002-1002

Other trials in Latvia

Norway1 site

  • Oslo Universitetssykehus-Ullevål

    Oslo, 0450

Other trials in Norway

Romania1 site

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

    Cluj-Napoca, Cluj, 400162

Other trials in Romania

Singapore1 site

  • National University Hospital

    Singapore, 119082

Other trials in Singapore

About this study

Official title: 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.

Read the 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.

Being tested
Placebo, Cenicriviroc
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

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

  • CenicrivirocDrug

    Also called CVC

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

Study groups in NCT03028740
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Receives: Drug: Placebo
Cenicriviroc 150 mgExperimentalParticipants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.
Receives: Drug: Cenicriviroc

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 12

  2. 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.

    Measured: From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months)

Secondary outcomes (11)

  1. 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

    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.

    Measured: Month 12

  2. Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at 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.

    Measured: Month 12

  3. Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at 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.

    Measured: Month 12

  4. 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

    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.

    Measured: Month 12

  5. 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

    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.

    Measured: Month 12

  6. 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

    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.

    Measured: Month 12

  7. 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

    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.

    Measured: Month 12

  8. 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

    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.

    Measured: Month 60

  9. 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

    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.

    Measured: Month 60

  10. 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

    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.

    Measured: Month 60

  11. 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

    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.

    Measured: Month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2017 (estimated)
  2. Study start5 Apr 2017
  3. Primary completion12 Jan 2021
  4. Study completion9 Mar 2021

Why it stopped: This study was terminated early due to lack of efficacy based on the results of the planned interim analysis of Part 1 data.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,778 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03028740
Sponsor's protocol ID
3152-301-002
Other IDs
2016-004566-26, 1001, 2016
Acronym
AURORA
Status last verified
Nov 2021
First submitted
13 Jan 2017
Last updated
10 Mar 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 37061109

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cenicriviroc in people with Nonalcoholic Steatohepatitis, run by Tobira Therapeutics, Inc. at 346 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 346 sites in United States, United Kingdom, France, Germany, Poland and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03028740, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.

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