Back to resultsAURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH) (AURORA)
Primary Purpose
Nonalcoholic Steatohepatitis
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Cenicriviroc
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis
Eligibility Criteria
Inclusion Criteria:
- Male and female participants aged between 18-75 years
- Ability to understand and sign a written informed consent form (ICF)
- Histological evidence of NASH based on central reading of the Screening biopsy
- Participants included in Part 1 must have histopathological evidence of Stage 2 or 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides. Participants newly randomized in Part 2 must have histological evidence of Stage 3 liver fibrosis per the NASH CRN System, based on central reading of the Screening period biopsy slides. Historical biopsy can be used, provided the criteria listed on Item 3a above are fulfilled.
- Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for ≥12 months and serum follicle-stimulating hormone (FSH) ≥30 milliunits (mU)/milliliter (mL) at Screening.
Exclusion Criteria:
- Inability to undergo a liver biopsy
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody (HCVAb) positive
- Human immunodeficiency virus (HIV)-1 or HIV-2 infection
- Prior or planned liver transplantation
- Other known causes of chronic liver disease
- History or presence of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
- Alcohol consumption greater than 21 units/week for males or 14 units/week for females
- Aspartate transaminase (AST) >200 International units (IU)/liter (L) in males and females at Screening
- Alanine transaminase (ALT) >250 IU/L in males and >200 IU/L in females at Screening
- Hemoglobin A1c (HbA1c) >10% at Screening
- Serum albumin <3.5 gram (g)/deciliter (dL) at Screening
- Estimated glomerular filtration rate (eGFR) < 50 mL/minute (min)/1.73 meter (m)^2 according to the Modification of Diet in Renal Disease (MDRD) equation
- Platelet count <100,000/millimeter (mm)^3
- Total bilirubin >1.5 milligram (mg)/dL
- International normalized ratio (INR) >1.3
- Model of end stage liver disease (MELD) score >12
- Weight reduction, defined as ≥7% of body weight, through bariatric surgery in the past 5 years or bariatric surgery planned during the conduct of the study (including gastric banding and sleeve surgery)
- History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
- Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
- Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
- Females who are pregnant or breastfeeding
- Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (eg, interleukins, interferons, cyclosporine, tacrolimus) except for vaccines or short-term corticosteroids
- Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) and/or sodium-glucose cotransporter (SGLT1) inhibitor, or a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver biopsy. Participants on a stable therapy with a GLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for at least 6 months prior to the Screening liver biopsy may be considered eligible. (Important Note: if a historical biopsy is to be used, participants need to be on stable therapy for at least 6 months prior to the day historical liver biopsy was performed).
Sites / Locations
- Summit Internal Medicine
- Cullman Clinical Trials
- Digestive Health Specialists of the Southeast
- Objective GI D/B/A North Alabama GI Research Center
- The Institute for Liver Health
- Adobe Gastroenterology Research, LLC
- Del Sol Research Management, LLC
- Del Sol Research Management LLC
- Arkansas Diagnostic Center
- Franco Felizarta MD
- Hope Clinical Research
- GW Research
- eStudySite
- Southern California Research Center
- Citrus Valley Gastroenterology
- TriWest Research Associates
- University of San Francisco, Fresno Medical Education Program
- Fresno Clinical Research Center (FCRC)
- National Research Institute
- University of California San Diego
- eStudySite
- Om Research
- Southern California Kaiser Permanente, Los Angeles Medical Center
- GastroIntestinal Biosciences
- Global Research Institute
- Ruane Medical and Liver Health Institute
- Cedars-Sinai Medical Group
- National Research Institute
- United Medical Doctors
- Palmtree Clinical Research Inc.
- National Research Institute
- Pasadena Liver Center
- Alliance Clinical Research LLC
- Stanford School of Medicine, Center for Clinical Sciences Research
- Inland Empire Liver Foundation
- Precision Research Institute
- Southern California Permanente Medical Group
- UCSF School of Medicine
- Upland Clinical Research
- Island View GI
- Peak Gastroenterology Associates
- South Denver Gastroenterology, PC
- Western States Clinical Research, Inc.
- Gastroenterology Associates of Fairfield County
- Yale University - New Haven
- Innovative Medical Research of South Florida, Inc.
- Gastro Florida
- Hi Tech and Global Research, LLC
- Top Medical Research, Inc
- ICR Sites
- Qway Research, LLC
- Gastroenterology Associates - Crystal River
- Mayo Clinic College of Medicine
- Meridien Research
- Florida Digestive Health Specialists
- Meridien Research
- San Marcus Research Clinic
- Clinical Pharmacology of Miami, LLC
- Bruce W. Carter Department of Veterans Affairs Medical Center
- Optimus U Corporation
- University of Miami Hospital
- Sanchez Clinical Research, Inc
- Genoma Research Group Inc.
- Medical Professional Clinical Research Center, INC
- ProLive Medical Research
- Advanced Research Institute, Inc.
- Bioclinical Research Alliance
- Omega Research Maitland, LLC
- IMIC, Inc
- Innovation Medical Research Center
- Gastroenterology Associates of Pensacola
- Advanced Medical Research
- Tampa General Hospital
- Guardian Angel Research Center
- Bioclinica Research
- Florida Medical Clinic
- Summit Clinical Research, LLC
- Digestive Healthcare of Georgia - Atlanta
- Piedmont Healthcare INC.
- Gastroenterology Associates of Central Georgia
- GI Specialists of Georgia - Marietta Office
- Northwestern University
- Rush University Medical Center
- Investigators Research Group, LLC
- Indianapolis Gastroenterology Research Foundation
- Aquiant Research
- Digestive Research Alliance of Michiana
- Iowa Digestive Disease Center
- University of Iowa Hospitals and Clinics
- University of Kansas Medical Center
- Kansas Medical Clinic-Gastroenterology
- Delta Research Partners, LLC
- Avant Research Associates LLC
- C-1 Headlands, Inc.
- Tandem Clinical Research
- Tulane University School of Medicine
- Ochsner Medical Center
- Nola Research Works, LLC
- Louisiana Research Center
- Clinical Trials of America LLC
- Mercy Medical Center
- Digestive Disease Associates
- Gastro Center of Maryland
- Woodholme Gastroenterology Associates
- Victory Clinical Research
- Meritus Center for Clinical Research
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Lahey Hospital & Medical Center
- Umass Memorial Medical Center
- Henry Ford Health System
- Minnesota Gastroenterology, P.A.
- National Diabetes and Obesity Research Institute
- GastroIntestinal Associates
- Clinical Research Professionals
- Saint Louis University
- Washington University School of Medicine
- Machuca Family Medicine
- Jubilee Clinical Research, Inc.
- Sierra Clinical Research
- Excel Clinical Research
- Dartmouth Hitchcock Medical Center
- Hassman Research Institute
- Amici Clinical Research
- Beth Israel Medical Center
- NYU Langone Health - Perlmutter Cancer Center
- Mount Sinai Medical Center
- Tandem Clinical Research
- Weill Cornell Medical College
- Investigational Drug Service, The University of North Carolina at Chapel Hill
- Carolinas Medical Center
- Northeast GI Research Division
- Duke University
- Cumberland Research Associates, LLC
- Carolina Research
- Wake Research Associates
- PMG Research of Winston-Salem
- Consultants for Clinical Research
- MetroHealth Medical Center
- The Ohio University - Gastroenterology, Hepatology
- Digestive Disease Specialist, Inc.
- Options Health Research
- Eastern Pennsylvania Gastroenterology and Liver Specialist
- UPMC -Center for Liver Diseases
- VA Pittsburgh Healthcare System
- Care Access Research, Pottsville
- Digestive Disease Associates, LTD
- Partners in Clinical Research
- University Medical Group
- Care Access Research-Warwick
- Rapid City Medical Center
- Mount Vernon Clinical Research
- Gastro One
- Digestive Health Research
- East Tennessee Research Institute
- Digestive Health Research
- UT-Memphis, Methodist University Hospital
- Vanderbilt University
- Texas Clinical Research Institute
- Methodist Dallas Medical Center
- Liver Center of Texas
- Synexus
- University of Texas Southwestern Medical Center
- San Antonio Military Medical Center
- Baylor Scott & White All Saints Medical Center - Ft. Worth
- Texas Digestive Disease Consultants - Fort Worth
- Digestive Health Associates of Texas-Rockwall
- Therapeutic Concepts, PA
- Pioneer Research Solutions, Inc.
- Liver Associates of Texas
- Baylor College of Medicine
- Michael E. DeBakey VA Medical Center (MEDVAMC)
- St. Luke's Medical Center
- Biopharma Informatic, LLC
- Centex Studies
- Biopharma Informatic, LLC
- Amir Ali Hassan, MD, PA
- Centex Studies, Inc.
- LinQ Research, LLC
- Quality Research Inc.
- American Research Corporation
- Clinical Trials of Texas Inc
- Diabetes & Glandular Disease Clinic, P.A. (DGD)
- Endeavor Clinical Trials, LLC
- Southern Star Research Institute, LLC SAGACT PLLC.
- Anson Medicine
- Mount Olympus Medical Research, LLC
- Texas Digestive Disease Consultants
- Physician's Research Options, LLC
- Intermountain Medical Center
- Advanced Clinical Research - Center for Digestive Health
- University of Utah
- Gastroenterology Associates of Northern Virginia
- Inova Fairfax Medical Campus
- Liver Institute of Virginia
- Digestive and Liver Disease Specialists
- McGuire Veterans Affairs Medical Center
- VCU Medical Center
- Gastroenterology Consultants of Southwest Virginia Research
- Harborview Medical Center
- Swedish Medical Center
- Liver Institute Northwest
- University of Washington Medical Center
- Marshall University Joan C. Edwards School of Medicine
- Royal Prince Alfred Hospital
- Saint George Hospital
- Royal Brisbane and Women's Hospital
- Royal Adelaide Hospital
- Flinders Medical Center
- Monash Medical Centre
- Austin Health
- Royal Perth Hospital
- Universitatsklinik far Innere Medizin
- Universitatsklinik far Innere Medizin II
- Klinikum Wels-Grieskirchen
- Universitair Ziekenhuis Antwerpen
- Hôpital Erasme
- Algemeen Ziekenhuis Maria Middelares
- Universitair Ziekenhuis Gent
- Cliniques Universitaires Saint-Luc
- Centre Hospitalier Chretien CHC
- Hospital das Clínicas da Universidade Federal de Minas Gerais
- Faculdade de Medicina de São José do Rio Preto Hospital de Base
- Hospital Universitário Clementino Fraga Filho
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- University of Calgary Liver Unit
- Bailey Health Clinic
- Vancouver General Hospital
- William Osler Health Centre, Brampton Memorial Hospital Campus
- Toronto Liver Centre
- Ecogene-21
- Centro de Investigaciones Clínicas Viña del Mar
- CHU de Strasbourg
- CHU De Bordeaux - Hôpital Haût-Lévèque CMC Magellan Unita de Recherche Clinique
- Centre Hospitalier Universitaire Estaing
- Centre Hospitalier Universitaire de Rennes- Hôpital Pontchaillou
- Centre Hospitalier Regional et Universitaire de Besancon - L'Hopital Jean Minjoz
- Departement d'Hacpatologie
- Hôpital Saint Antoine
- CHU de Montpellier
- Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle
- Center Hospitalier Universitaire d'Angers
- Hapital Sud Service d'Hepato- Gastroentarologie
- Centre Hospitalier Universitaire de Nice Hôpital l'Archet
- Centre Hospitalier Universitaire Grenoble
- Hopital Avicenne
- Synexus Clinical Research GmbH, Prüfzentrum Frankfurt
- Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
- Medizinische Hochschule Hannover
- Gastroenterologische Gemeinschaftspraxis
- Uniklinik RWTH Aachen
- Uniklinik Köln
- Universitätsmedizin der Johannes Gutenberg Universität Mainz
- Universitätsklinikum des Saarlandes
- Universitätsklinikum Leipzig
- Praxis Driesener Strasse
- Synexus Clinical Research GmbH, Prüfzentrum Berlin
- Charité Universitätsmedizin Berlin
- Universitätsklinikum Hamburg Eppendorf
- Thomopoulos Gastroenterology Dept.
- Hippokratio Hospital
- Prince of Wales Hospital
- Alice Ho Miu Ling Nethersole Hospital
- Somogy Megyei Kaposi Mór Oktató Kórház
- SYNEXUS Magyarország Kft. - Budapest DRS
- Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft
- EMMS MC
- Rambam Health Care Campus - Rambam Medical Center
- Carmel Medical Center
- Shaare Zedek Medical Center
- Hadassah Medical Center, Institute of Gastroenterology and Liver Diseases
- Galilee Medical Center
- Rabin Medical Center Beilinson Hospital
- Tel Aviv Sourasky Medical Center
- Sheba Medical Center
- Ospedale Casa Sollievo della Sofferenza
- ASST Grande Ospedale Metropolitano Niguarda
- Istituto Clinico Humanitas
- Azienda Ospedaliera Universitaria Careggi SOD Medicina Interna ed Epatologia
- ASST Santi Paolo e Carlo
- Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
- Fondazione Policlinico Tor Vergata
- Fondazione Policlinico Universitario Agostino Gemelli
- Pauls Stradins Clinical University Hospital
- Consultorio Médico Dr. Alma Laura Ladron de Guevara
- JM Research - Cuernavaca
- Investigaciones Medicas Cisneros
- Consultorio Dra. Maria Sarai Gonzalez Huezo
- Auckland City Hospital
- Middlemore Clinical Trials
- Oslo Universitetssykehus-Ullevål
- Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska
- EMC Instytut Medyczny
- Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
- Synexus Polska Sp. z o.o. Oddział w Łodzi
- Szpital Specjalistyczny Nr 1 w Bytomiu
- ID Clinic Arkadiusz Pisula
- Synexus Polska Sp z o o Oddzial w Poznaniu
- Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
- Synexus Polska Sp. Z o.o. Oddzial w Czestochowie
- Synexus Polska Sp. z o.o. Oddzial w Gdansku
- Synexus Polska Sp. z o.o. Oddzial w Gdyni ul.
- Synexus SCM Sp. z o.o. Oddzial
- Synexus Polska Sp. z o.o. Oddział w Warszawie
- Presa-Ramos
- Unidade Local de Saúde do Alto Minho
- Clinical Research Puerto Rico
- Fundacion de Investigacion De Diego
- Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor
- Clinic Professor Gorbakova
- Sklifosovsky Scientific Research Institution of Emergency Care
- Moscow Regional Research and Clinical Institute M.F. Vladimirsky
- National University Hospital
- Hospital Universitari Germans Trias i Pujol
- Hospital Universitario Donostia
- Complejo Hospitalario Torrecardenas
- Hospital del Mar
- Hospital Universitari Vall d'Hebrón
- Hospital General Universitario Gregorio Marañon
- Hospital Universitario Ramón Y Cajal
- Hospital Clínico Universitario Virgen de la Victoria
- Hospital Universitario Marqués de Valdecilla
- Hospital Universitario Virgen del Rocio
- Hospital Universitario Nuestra Senora de Valme
- Consorci Hospital General Universitari de València
- Hospital Universitari i Politecnic La Fe de Valencia
- Kantonsspital St.Gallen Klinik für
- Universitaetsspital Bern Inselspital
- Chia-Yi Christian Hospital
- China Medical University Hospital
- Chang Gung Medical Foundation-LinKou Branch
- University Hospitals Birmingham NHS Foundation Trust
- Hull and East Yorkshire Hospitals NHS Trust
- Royal Free London NHS Foundation Trust
- Kings College Hospital NHS Foundation Trust
- Chelsea and Westminster Hospital NHS Foundation Trust
- Luton and Dunstable Hospital NHS Foundation Trust
- Newcastle Upon the Tyne Hospitals
- Nottingham Digestive Diseases Biomedical Research Unit
- Plymouth Hospitals NHS Trust
- Royal Stoke University Hospital
- St James's University Hospital
- Synexus Hexham Clinical Research Centre
- Synexus Lancashire Clinical Research Centre
- Barts Health NHS Trust The Royal London Hospital
- University Hospital of South Manchester NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Cenicriviroc 150 mg
Arm Description
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03028740
First Posted
January 13, 2017
Last Updated
February 11, 2022
Sponsor
Tobira Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03028740
Brief Title
AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
Acronym
AURORA
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early due to lack of efficacy based on the results of the planned interim analysis of Part 1 data.
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
January 12, 2021 (Actual)
Study Completion Date
March 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tobira Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1778 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Arm Title
Cenicriviroc 150 mg
Arm Type
Experimental
Arm Description
Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months.
Intervention Type
Drug
Intervention Name(s)
Cenicriviroc
Other Intervention Name(s)
CVC
Intervention Description
Cenicriviroc, 150 mg, tablet, orally, once daily for up to approximately 40 months.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Month 12
Title
Time to First Occurrence of Adjudicated Events in the Full Study Cohort
Description
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.
Time Frame
From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months)
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Month 12
Title
Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12
Description
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.
Time Frame
Month 12
Title
Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12
Description
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.
Time Frame
Month 12
Title
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
Description
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.
Time Frame
Month 12
Title
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
Description
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.
Time Frame
Month 12
Title
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
Description
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.
Time Frame
Month 12
Title
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
Description
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.
Time Frame
Month 12
Title
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
Description
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.
Time Frame
Month 60
Title
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
Description
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.
Time Frame
Month 60
Title
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
Description
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.
Time Frame
Month 60
Title
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
Description
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.
Time Frame
Month 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female participants aged between 18-75 years
Ability to understand and sign a written informed consent form (ICF)
Histological evidence of NASH based on central reading of the Screening biopsy
Participants included in Part 1 must have histopathological evidence of Stage 2 or 3 liver fibrosis per the NASH CRN System based on central reading of the Screening biopsy slides. Participants newly randomized in Part 2 must have histological evidence of Stage 3 liver fibrosis per the NASH CRN System, based on central reading of the Screening period biopsy slides. Historical biopsy can be used, provided the criteria listed on Item 3a above are fulfilled.
Females of childbearing potential and males participating in the study must agree to use at least 2 approved methods of contraception throughout the duration of the study and for 30 days after stopping study drug. Females who are postmenopausal must have documentation of cessation of menses for ≥12 months and serum follicle-stimulating hormone (FSH) ≥30 milliunits (mU)/milliliter (mL) at Screening.
Exclusion Criteria:
Inability to undergo a liver biopsy
Hepatitis B surface antigen (HBsAg) positive
Hepatitis C antibody (HCVAb) positive
Human immunodeficiency virus (HIV)-1 or HIV-2 infection
Prior or planned liver transplantation
Other known causes of chronic liver disease
History or presence of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
Alcohol consumption greater than 21 units/week for males or 14 units/week for females
Aspartate transaminase (AST) >200 International units (IU)/liter (L) in males and females at Screening
Alanine transaminase (ALT) >250 IU/L in males and >200 IU/L in females at Screening
Hemoglobin A1c (HbA1c) >10% at Screening
Serum albumin <3.5 gram (g)/deciliter (dL) at Screening
Estimated glomerular filtration rate (eGFR) < 50 mL/minute (min)/1.73 meter (m)^2 according to the Modification of Diet in Renal Disease (MDRD) equation
Platelet count <100,000/millimeter (mm)^3
Total bilirubin >1.5 milligram (mg)/dL
International normalized ratio (INR) >1.3
Model of end stage liver disease (MELD) score >12
Weight reduction, defined as ≥7% of body weight, through bariatric surgery in the past 5 years or bariatric surgery planned during the conduct of the study (including gastric banding and sleeve surgery)
History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
Females who are pregnant or breastfeeding
Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (eg, interleukins, interferons, cyclosporine, tacrolimus) except for vaccines or short-term corticosteroids
Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) and/or sodium-glucose cotransporter (SGLT1) inhibitor, or a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver biopsy. Participants on a stable therapy with a GLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for at least 6 months prior to the Screening liver biopsy may be considered eligible. (Important Note: if a historical biopsy is to be used, participants need to be on stable therapy for at least 6 months prior to the day historical liver biopsy was performed).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerardo Rodriguez
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Summit Internal Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Cullman Clinical Trials
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Facility Name
Digestive Health Specialists of the Southeast
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Objective GI D/B/A North Alabama GI Research Center
City
Madison
State/Province
Alabama
ZIP/Postal Code
35758
Country
United States
Facility Name
The Institute for Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Adobe Gastroenterology Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Del Sol Research Management, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Del Sol Research Management LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Arkansas Diagnostic Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Franco Felizarta MD
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
GW Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
eStudySite
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Citrus Valley Gastroenterology
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
TriWest Research Associates
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
University of San Francisco, Fresno Medical Education Program
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Fresno Clinical Research Center (FCRC)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
National Research Institute
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Om Research
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Southern California Kaiser Permanente, Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
GastroIntestinal Biosciences
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Global Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Ruane Medical and Liver Health Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Cedars-Sinai Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
United Medical Doctors
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
Facility Name
Palmtree Clinical Research Inc.
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
National Research Institute
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Pasadena Liver Center
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Alliance Clinical Research LLC
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Stanford School of Medicine, Center for Clinical Sciences Research
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377-4697
Country
United States
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
Facility Name
UCSF School of Medicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0538
Country
United States
Facility Name
Upland Clinical Research
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Island View GI
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
South Denver Gastroenterology, PC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Western States Clinical Research, Inc.
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Gastroenterology Associates of Fairfield County
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Yale University - New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Innovative Medical Research of South Florida, Inc.
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Gastro Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Hi Tech and Global Research, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Top Medical Research, Inc
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Facility Name
ICR Sites
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Qway Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Facility Name
Gastroenterology Associates - Crystal River
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Mayo Clinic College of Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Meridien Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Facility Name
Florida Digestive Health Specialists
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Meridien Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
San Marcus Research Clinic
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Clinical Pharmacology of Miami, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Bruce W. Carter Department of Veterans Affairs Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Optimus U Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Sanchez Clinical Research, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Genoma Research Group Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Medical Professional Clinical Research Center, INC
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
ProLive Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Advanced Research Institute, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Bioclinical Research Alliance
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Omega Research Maitland, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
IMIC, Inc
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Innovation Medical Research Center
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Gastroenterology Associates of Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Advanced Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Guardian Angel Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Bioclinica Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Florida Medical Clinic
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Summit Clinical Research, LLC
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Digestive Healthcare of Georgia - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Piedmont Healthcare INC.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
GI Specialists of Georgia - Marietta Office
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Investigators Research Group, LLC
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Aquiant Research
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Digestive Research Alliance of Michiana
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46635
Country
United States
Facility Name
Iowa Digestive Disease Center
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kansas Medical Clinic-Gastroenterology
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Delta Research Partners, LLC
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
Avant Research Associates LLC
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
C-1 Headlands, Inc.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Nola Research Works, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125
Country
United States
Facility Name
Louisiana Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Clinical Trials of America LLC
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Digestive Disease Associates
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Gastro Center of Maryland
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Woodholme Gastroenterology Associates
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Victory Clinical Research
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Meritus Center for Clinical Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Umass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55117
Country
United States
Facility Name
National Diabetes and Obesity Research Institute
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39532
Country
United States
Facility Name
GastroIntestinal Associates
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Clinical Research Professionals
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Machuca Family Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Jubilee Clinical Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Sierra Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Excel Clinical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Amici Clinical Research
City
Raritan
State/Province
New Jersey
ZIP/Postal Code
08869
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
NYU Langone Health - Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Tandem Clinical Research
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Investigational Drug Service, The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Northeast GI Research Division
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28027
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Carolina Research
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
The Ohio University - Gastroenterology, Hepatology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Digestive Disease Specialist, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Options Health Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Eastern Pennsylvania Gastroenterology and Liver Specialist
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
UPMC -Center for Liver Diseases
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Care Access Research, Pottsville
City
Pottsville
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States
Facility Name
Digestive Disease Associates, LTD
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Partners in Clinical Research
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
University Medical Group
City
North Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Care Access Research-Warwick
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Rapid City Medical Center
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Mount Vernon Clinical Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Digestive Health Research
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
East Tennessee Research Institute
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Digestive Health Research
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37090
Country
United States
Facility Name
UT-Memphis, Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-1610
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Liver Center of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Synexus
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
San Antonio Military Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Baylor Scott & White All Saints Medical Center - Ft. Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Digestive Disease Consultants - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Digestive Health Associates of Texas-Rockwall
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Therapeutic Concepts, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
Liver Associates of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3002
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center (MEDVAMC)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke's Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Centex Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Amir Ali Hassan, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Centex Studies, Inc.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
LinQ Research, LLC
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584
Country
United States
Facility Name
Quality Research Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
American Research Corporation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical Trials of Texas Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Diabetes & Glandular Disease Clinic, P.A. (DGD)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Endeavor Clinical Trials, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Southern Star Research Institute, LLC SAGACT PLLC.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Anson Medicine
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78260
Country
United States
Facility Name
Mount Olympus Medical Research, LLC
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Physician's Research Options, LLC
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Advanced Clinical Research - Center for Digestive Health
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Gastroenterology Associates of Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Inova Fairfax Medical Campus
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Liver Institute of Virginia
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
McGuire Veterans Affairs Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
VCU Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Gastroenterology Consultants of Southwest Virginia Research
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Liver Institute Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Marshall University Joan C. Edwards School of Medicine
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Saint George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Center
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Universitatsklinik far Innere Medizin
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Facility Name
Universitatsklinik far Innere Medizin II
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen
City
Wels
State/Province
Upper Austria
ZIP/Postal Code
4600
Country
Austria
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Hôpital Erasme
City
Bruxelles
State/Province
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Algemeen Ziekenhuis Maria Middelares
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Centre Hospitalier Chretien CHC
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Hospital das Clínicas da Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Faculdade de Medicina de São José do Rio Preto Hospital de Base
City
São José do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Hospital Universitário Clementino Fraga Filho
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
University of Calgary Liver Unit
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Bailey Health Clinic
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 4B9
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
William Osler Health Centre, Brampton Memorial Hospital Campus
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Ecogene-21
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Centro de Investigaciones Clínicas Viña del Mar
City
Viña del Mar
State/Province
Valparaiso
ZIP/Postal Code
2540488
Country
Chile
Facility Name
CHU de Strasbourg
City
Strasbourg cedex
State/Province
Alsace
ZIP/Postal Code
67091
Country
France
Facility Name
CHU De Bordeaux - Hôpital Haût-Lévèque CMC Magellan Unita de Recherche Clinique
City
Pessac
State/Province
Aquitaine
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Universitaire Estaing
City
Clermont-Ferrand
State/Province
Aubergne
ZIP/Postal Code
63003
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes- Hôpital Pontchaillou
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Hospitalier Regional et Universitaire de Besancon - L'Hopital Jean Minjoz
City
Besançon cedex
State/Province
Franche-Comte
ZIP/Postal Code
25030
Country
France
Facility Name
Departement d'Hacpatologie
City
Clichy
State/Province
Ile-De-France
ZIP/Postal Code
92110
Country
France
Facility Name
Hôpital Saint Antoine
City
Paris Cedex 12
State/Province
Ile-de-France
ZIP/Postal Code
75571
Country
France
Facility Name
CHU de Montpellier
City
Montpellier cedex 5
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle
City
Rouen
State/Province
Normandie
ZIP/Postal Code
76000
Country
France
Facility Name
Center Hospitalier Universitaire d'Angers
City
Angers
State/Province
Pays De La Loire
ZIP/Postal Code
49000
Country
France
Facility Name
Hapital Sud Service d'Hepato- Gastroentarologie
City
Amiens Cedex 1
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice Hôpital l'Archet
City
Nice Cedex 3
State/Province
Provence Alpes Cote D'Azur
ZIP/Postal Code
06202
Country
France
Facility Name
Centre Hospitalier Universitaire Grenoble
City
Grenoble Cedex 09
State/Province
Rhone-Alpes
ZIP/Postal Code
38700
Country
France
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Synexus Clinical Research GmbH, Prüfzentrum Frankfurt
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60313
Country
Germany
Facility Name
Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis
City
Herne
State/Province
Nordhein-Westfalen
ZIP/Postal Code
44623
Country
Germany
Facility Name
Uniklinik RWTH Aachen
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Uniklinik Köln
City
Köln
State/Province
Nordrhein-westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg Universität Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66427
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Praxis Driesener Strasse
City
Berlin
ZIP/Postal Code
10439
Country
Germany
Facility Name
Synexus Clinical Research GmbH, Prüfzentrum Berlin
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Thomopoulos Gastroenterology Dept.
City
Patra
State/Province
Peloponnese
ZIP/Postal Code
26504
Country
Greece
Facility Name
Hippokratio Hospital
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Prince of Wales Hospital
City
Shatin
State/Province
New Territories
ZIP/Postal Code
00852
Country
Hong Kong
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Shatin
State/Province
New Territories
Country
Hong Kong
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400-7400
Country
Hungary
Facility Name
SYNEXUS Magyarország Kft. - Budapest DRS
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft
City
Debrecen
ZIP/Postal Code
4025
Country
Hungary
Facility Name
EMMS MC
City
Nazareth
State/Province
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Rambam Health Care Campus - Rambam Medical Center
City
Haifa
ZIP/Postal Code
31999
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Hadassah Medical Center, Institute of Gastroenterology and Liver Diseases
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center Beilinson Hospital
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milan
State/Province
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi SOD Medicina Interna ed Epatologia
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
ASST Santi Paolo e Carlo
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Fondazione Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002-1002
Country
Latvia
Facility Name
Consultorio Médico Dr. Alma Laura Ladron de Guevara
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
JM Research - Cuernavaca
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Investigaciones Medicas Cisneros
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Consultorio Dra. Maria Sarai Gonzalez Huezo
City
Metepec
ZIP/Postal Code
52140
Country
Mexico
Facility Name
Auckland City Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Oslo Universitetssykehus-Ullevål
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
51-162
Country
Poland
Facility Name
EMC Instytut Medyczny
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
54-144
Country
Poland
Facility Name
Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
City
Lódz
State/Province
Lodzkie
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddział w Łodzi
City
Łódź
State/Province
Lodz
ZIP/Postal Code
90-127
Country
Poland
Facility Name
Szpital Specjalistyczny Nr 1 w Bytomiu
City
Bytom
State/Province
Slaskie
ZIP/Postal Code
41-902
Country
Poland
Facility Name
ID Clinic Arkadiusz Pisula
City
Myslowice
State/Province
Slaskie
ZIP/Postal Code
41400-400
Country
Poland
Facility Name
Synexus Polska Sp z o o Oddzial w Poznaniu
City
Poznań
State/Province
Wielkopolska
ZIP/Postal Code
60 702-702
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
City
Wrocław
State/Province
Wroclaw
ZIP/Postal Code
50-381
Country
Poland
Facility Name
Synexus Polska Sp. Z o.o. Oddzial w Czestochowie
City
Czestochowa
ZIP/Postal Code
0 42-202
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdansku
City
Gdańsk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Gdyni ul.
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
Synexus SCM Sp. z o.o. Oddzial
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
Synexus Polska Sp. z o.o. Oddział w Warszawie
City
Warsaw
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Presa-Ramos
City
Vila Real
State/Province
Lordelo
ZIP/Postal Code
5000-508
Country
Portugal
Facility Name
Unidade Local de Saúde do Alto Minho
City
Viana do Castelo
ZIP/Postal Code
4904-858
Country
Portugal
Facility Name
Clinical Research Puerto Rico
City
San Juan
ZIP/Postal Code
00909-1711
Country
Puerto Rico
Facility Name
Fundacion de Investigacion De Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400162
Country
Romania
Facility Name
Clinic Professor Gorbakova
City
Krasnogorsk
State/Province
Moscow
ZIP/Postal Code
143405
Country
Russian Federation
Facility Name
Sklifosovsky Scientific Research Institution of Emergency Care
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Moscow Regional Research and Clinical Institute M.F. Vladimirsky
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119082
Country
Singapore
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Donostia
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Facility Name
Complejo Hospitalario Torrecardenas
City
Almeria
ZIP/Postal Code
4009
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramón Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clínico Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario Nuestra Senora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Consorci Hospital General Universitari de València
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Kantonsspital St.Gallen Klinik für
City
St. Gallen
State/Province
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Universitaetsspital Bern Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Chia-Yi Christian Hospital
City
Chiayi City
State/Province
Chiayi
ZIP/Postal Code
60002
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
State/Province
Taichung City
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Chang Gung Medical Foundation-LinKou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Hull and East Yorkshire Hospitals NHS Trust
City
Hull
State/Province
England
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Kings College Hospital NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Luton and Dunstable Hospital NHS Foundation Trust
City
Luton
State/Province
England
ZIP/Postal Code
LU4 0DZ
Country
United Kingdom
Facility Name
Newcastle Upon the Tyne Hospitals
City
Newcastle
State/Province
England
ZIP/Postal Code
NE2 7DN
Country
United Kingdom
Facility Name
Nottingham Digestive Diseases Biomedical Research Unit
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Plymouth Hospitals NHS Trust
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
State/Province
England
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS97TF
Country
United Kingdom
Facility Name
Synexus Hexham Clinical Research Centre
City
Hexham
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Synexus Lancashire Clinical Research Centre
City
Lancaster
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Barts Health NHS Trust The Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
University Hospital of South Manchester NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
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