AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
- Registration Number
- NCT03028740
- Lead Sponsor
- Tobira Therapeutics, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1778
- 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.
- Inability to undergo a liver biopsy
- Hepatitis B surface antigen (HBsAg) positive
- Hepatitis C antibody (HCVAb) positive
- Human immunodeficiency virus (HIV)-1 or HIV-2 infection
- Prior or planned liver transplantation
- Other known causes of chronic liver disease
- History or presence of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
- Alcohol consumption greater than 21 units/week for males or 14 units/week for females
- Aspartate transaminase (AST) >200 International units (IU)/liter (L) in males and females at Screening
- Alanine transaminase (ALT) >250 IU/L in males and >200 IU/L in females at Screening
- Hemoglobin A1c (HbA1c) >10% at Screening
- Serum albumin <3.5 gram (g)/deciliter (dL) at Screening
- Estimated glomerular filtration rate (eGFR) < 50 mL/minute (min)/1.73 meter (m)^2 according to the Modification of Diet in Renal Disease (MDRD) equation
- Platelet count <100,000/millimeter (mm)^3
- Total bilirubin >1.5 milligram (mg)/dL
- International normalized ratio (INR) >1.3
- Model of end stage liver disease (MELD) score >12
- Weight reduction, defined as ≥7% of body weight, through bariatric surgery in the past 5 years or bariatric surgery planned during the conduct of the study (including gastric banding and sleeve surgery)
- History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous cell carcinoma
- Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening Visit
- Clinically significant cardiovascular or cerebrovascular disease within the past 3 months
- Females who are pregnant or breastfeeding
- Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (eg, interleukins, interferons, cyclosporine, tacrolimus) except for vaccines or short-term corticosteroids
- Receiving a glucagon-like peptide 1 (GLP-1) receptor agonist, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a sodium-glucose cotransporter 2 (SGLT2) and/or sodium-glucose cotransporter (SGLT1) inhibitor, or a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver biopsy. Participants on a stable therapy with a GLP-1 receptor agonist, DPP-4 inhibitor, SGLT1 and/or SGLT2 inhibitor, or a TZD for at least 6 months prior to the Screening liver biopsy may be considered eligible. (Important Note: if a historical biopsy is to be used, participants need to be on stable therapy for at least 6 months prior to the day historical liver biopsy was performed).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received cenicriviroc placebo-matching, tablet, orally, once daily for up to approximately 40 months. Cenicriviroc 150 mg Cenicriviroc Participants received cenicriviroc, 150 milligrams (mg), tablet, orally, once daily for up to approximately 40 months.
- Primary Outcome Measures
Name Time Method Time to First Occurrence of Adjudicated Events in the Full Study Cohort From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months) Time to first occurrence from Baseline was defined as the number of days from the first dose of randomized investigational product to the onset of the first occurrence of any of the following adjudicated events: death (all cause), histopathologic progression to cirrhosis, liver transplant, model for end stage liver disease (MELD) score ≥15, ascites, hospitalization for onset of: variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis. MELD is a scoring system for assessing the severity of chronic liver disease and uses the participant's values for total bilirubin, serum creatinine, and the international normalized ratio for prothrombin time to predict survival. MELD score ranges from 6 (less ill) to 40 (gravely ill) with scores and mortality probability being: Score 40=71.3% mortality; Scores 30-39=52.6% mortality; Scores 20-29=19.6% mortality; Scores10-19=6.0% mortality; Score 9 or less=1.9% mortality.
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 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.
- Secondary Outcome Measures
Name Time Method Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12 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 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 and No Worsening of Steatohepatitis on Liver Histology at Month 12 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.
Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort Month 12 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 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 2 Stages and No Worsening of Steatohepatitis on Liver Biopsy at Month 12 in the Full Study Cohort 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.
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 Month 60 Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages 0=none, 1=perisinusoidal or periportal, 1A=mild, zone 3, perisinusoidal, 1B=moderate, zone 3, perisinusoidal, 1C=portal/periportal, 2=perisinusoidal and portal/periportal, 3=bridging fibrosis, 4=cirrhosis.
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 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 60 in the Full Study Cohort Month 60 Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=\<5% to 3=\>66%), lobular inflammation (0=no foci to 3=\>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
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 Month 60 Fibrosis stage was evaluated using the NASH CRN Fibrosis Staging System with stages: 0=none; 1=perisinusoidal or periportal; 1A=mild, zone 3, perisinusoidal; 1B=moderate, zone 3, perisinusoidal; 1C=portal/periportal; 2=perisinusoidal and portal/periportal; 3=bridging fibrosis; 4=cirrhosis. No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant NAS categories. NAS is a semiquantitative scoring system based on the unweighted sum of: steatosis (0=\<5% to 3=\>66%), lobular inflammation (0=no foci to 3=\>4 foci/200x), and hepatocellular ballooning (0=none to 2=many cells/prominent ballooning) scores. Improvement in fibrosis is a decrease in the NASH CRN fibrosis stage.
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 Month 60 Fibrosis stage was evaluated using NASH CRN Fibrosis Staging System with stages 0=None, 1=Perisinusoidal or periportal, 1A=Mild, zone 3, perisinusoidal, 1B=Moderate, zone 3, perisinusoidal, 1C=Portal/periportal, 2=Perisinusoidal and portal/periportal, 3=Bridging fibrosis, 4=Cirrhosis.
Trial Locations
- Locations (339)
Gastroenterology Associates of Fairfield County
🇺🇸Bridgeport, Connecticut, United States
Qway Research, LLC
🇺🇸Hialeah, Florida, United States
Options Health Research
🇺🇸Tulsa, Oklahoma, United States
Liver Center of Texas
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Digestive Healthcare of Georgia - Atlanta
🇺🇸Atlanta, Georgia, United States
Southern California Kaiser Permanente, Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Group
🇺🇸Los Angeles, California, United States
GastroIntestinal Biosciences
🇺🇸Los Angeles, California, United States
Global Research Institute
🇺🇸Los Angeles, California, United States
Ruane Medical and Liver Health Institute
🇺🇸Los Angeles, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
The Ohio University - Gastroenterology, Hepatology
🇺🇸Columbus, Ohio, United States
UPMC -Center for Liver Diseases
🇺🇸Pittsburgh, Pennsylvania, United States
VA Pittsburgh Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States
Bruce W. Carter Department of Veterans Affairs Medical Center
🇺🇸Miami, Florida, United States
Optimus U Corporation
🇺🇸Miami, Florida, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
Sanchez Clinical Research, Inc
🇺🇸Miami, Florida, United States
Genoma Research Group Inc.
🇺🇸Miami, Florida, United States
Medical Professional Clinical Research Center, INC
🇺🇸Miami, Florida, United States
ProLive Medical Research
🇺🇸Miami, Florida, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
St. Luke's Medical Center
🇺🇸Houston, Texas, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Liver Associates of Texas
🇺🇸Houston, Texas, United States
Amir Ali Hassan, MD, PA
🇺🇸Houston, Texas, United States
Liver Institute Northwest
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Digestive Disease Associates
🇺🇸Catonsville, Maryland, United States
Woodholme Gastroenterology Associates
🇺🇸Glen Burnie, Maryland, United States
Synexus SCM Sp. z o.o. Oddzial
🇵🇱Katowice, Poland
Southern California Permanente Medical Group
🇺🇸San Diego, California, United States
Machuca Family Medicine
🇺🇸Las Vegas, Nevada, United States
Jubilee Clinical Research, Inc.
🇺🇸Las Vegas, Nevada, United States
Sierra Clinical Research
🇺🇸Las Vegas, Nevada, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
Duke University
🇺🇸Durham, North Carolina, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Quality Research Inc.
🇺🇸San Antonio, Texas, United States
American Research Corporation
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas Inc
🇺🇸San Antonio, Texas, United States
Diabetes & Glandular Disease Clinic, P.A. (DGD)
🇺🇸San Antonio, Texas, United States
Endeavor Clinical Trials, LLC
🇺🇸San Antonio, Texas, United States
Anson Medicine
🇺🇸San Antonio, Texas, United States
Southern Star Research Institute, LLC SAGACT PLLC.
🇺🇸San Antonio, Texas, United States
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Saarland, Germany
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Universitatsklinik far Innere Medizin II
🇦🇹Innsbruck, Tyrol, Austria
Oslo Universitetssykehus-Ullevål
🇳🇴Oslo, Norway
National University Hospital
🇸🇬Singapore, Singapore
Weill Cornell Medical College
🇺🇸New York, New York, United States
Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle
🇫🇷Rouen, Normandie, France
University of California San Diego
🇺🇸La Jolla, California, United States
Hull and East Yorkshire Hospitals NHS Trust
🇬🇧Hull, England, United Kingdom
China Medical University Hospital
🇨🇳Taichung, Taichung City, Taiwan
Kings College Hospital NHS Foundation Trust
🇬🇧London, England, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
🇬🇧London, England, United Kingdom
Investigaciones Medicas Cisneros
🇲🇽Monterrey, Nuevo Leon, Mexico
Consultorio Dra. Maria Sarai Gonzalez Huezo
🇲🇽Metepec, Mexico
Unidade Local de Saúde do Alto Minho
🇵🇹Viana do Castelo, Portugal
JM Research - Cuernavaca
🇲🇽Cuernavaca, Morelos, Mexico
CHU de Strasbourg
🇫🇷Strasbourg cedex, Alsace, France
Consultorio Médico Dr. Alma Laura Ladron de Guevara
🇲🇽Mexico, Distrito Federal, Mexico
Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor
🇷🇴Cluj-Napoca, Cluj, Romania
Chang Gung Medical Foundation-LinKou Branch
🇨🇳Taoyuan, Taiwan
Newcastle Upon the Tyne Hospitals
🇬🇧Newcastle, England, United Kingdom
Centre Hospitalier Universitaire de Rennes- Hôpital Pontchaillou
🇫🇷Rennes, Bretagne, France
Nottingham Digestive Diseases Biomedical Research Unit
🇬🇧Nottingham, England, United Kingdom
Luton and Dunstable Hospital NHS Foundation Trust
🇬🇧Luton, England, United Kingdom
Plymouth Hospitals NHS Trust
🇬🇧Plymouth, England, United Kingdom
UCSF School of Medicine
🇺🇸San Francisco, California, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Summit Internal Medicine
🇺🇸Birmingham, Alabama, United States
William Osler Health Centre, Brampton Memorial Hospital Campus
🇨🇦Brampton, Ontario, Canada
Centre Hospitalier Universitaire Grenoble
🇫🇷Grenoble Cedex 09, Rhone-Alpes, France
GW Research
🇺🇸Chula Vista, California, United States
Franco Felizarta MD
🇺🇸Bakersfield, California, United States
Meridien Research
🇺🇸Maitland, Florida, United States
San Marcus Research Clinic
🇺🇸Miami Lakes, Florida, United States
Summit Clinical Research, LLC
🇺🇸Athens, Georgia, United States
Bioclinica Research
🇺🇸The Villages, Florida, United States
Piedmont Healthcare INC.
🇺🇸Atlanta, Georgia, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Digestive Disease Associates, LTD
🇺🇸Wyomissing, Pennsylvania, United States
Delta Research Partners, LLC
🇺🇸Bastrop, Louisiana, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States
Amici Clinical Research
🇺🇸Raritan, New Jersey, United States
Care Access Research-Warwick
🇺🇸Warwick, Rhode Island, United States
Avant Research Associates LLC
🇺🇸Crowley, Louisiana, United States
National Diabetes and Obesity Research Institute
🇺🇸Biloxi, Mississippi, United States
Texas Clinical Research Institute
🇺🇸Arlington, Texas, United States
Carolina Research
🇺🇸Greenville, North Carolina, United States
NYU Langone Health - Perlmutter Cancer Center
🇺🇸New York, New York, United States
Mount Vernon Clinical Research
🇺🇸Chattanooga, Tennessee, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Michael E. DeBakey VA Medical Center (MEDVAMC)
🇺🇸Houston, Texas, United States
Mount Olympus Medical Research, LLC
🇺🇸Sugar Land, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
CHU De Bordeaux - Hôpital Haût-Lévèque CMC Magellan Unita de Recherche Clinique
🇫🇷Pessac, Aquitaine, France
Centre Hospitalier Universitaire Estaing
🇫🇷Clermont-Ferrand, Aubergne, France
Marshall University Joan C. Edwards School of Medicine
🇺🇸Huntington, West Virginia, United States
Algemeen Ziekenhuis Maria Middelares
🇧🇪Gent, Oost-Vlaanderen, Belgium
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Faculdade de Medicina de São José do Rio Preto Hospital de Base
🇧🇷São José do Rio Preto, Sao Paulo, Brazil
Klinikum Wels-Grieskirchen
🇦🇹Wels, Upper Austria, Austria
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Universitatsklinik far Innere Medizin
🇦🇹Graz, Styria, Austria
Centre Hospitalier Regional et Universitaire de Besancon - L'Hopital Jean Minjoz
🇫🇷Besançon cedex, Franche-Comte, France
Universitair Ziekenhuis Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Hospital das Clínicas da Universidade Federal de Minas Gerais
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Antwerpen, Belgium
Bailey Health Clinic
🇨🇦Edmonton, Alberta, Canada
Gastroenterologische Gemeinschaftspraxis
🇩🇪Herne, Nordhein-Westfalen, Germany
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Centro de Investigaciones Clínicas Viña del Mar
🇨🇱Viña del Mar, Valparaiso, Chile
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Departement d'Hacpatologie
🇫🇷Clichy, Ile-De-France, France
Hopital Avicenne
🇫🇷Bobigny, France
Synexus Clinical Research GmbH, Prüfzentrum Frankfurt
🇩🇪Frankfurt, Hessen, Germany
Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Marburg, Hessen, Germany
Center Hospitalier Universitaire d'Angers
🇫🇷Angers, Pays De La Loire, France
Galilee Medical Center
🇮🇱Nahariya, Israel
Fondazione Policlinico Tor Vergata
🇮🇹Roma, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milan, Milano, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
ASST Santi Paolo e Carlo
🇮🇹Milano, Italy
Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska
🇵🇱Wroclaw, Dolnoslaskie, Poland
EMC Instytut Medyczny
🇵🇱Wroclaw, Dolnoslaskie, Poland
Synexus Polska Sp. z o.o. Oddział w Łodzi
🇵🇱Łódź, Lodz, Poland
Synexus Polska Sp. z o.o. Oddział w Warszawie
🇵🇱Warsaw, Poland
Presa-Ramos
🇵🇹Vila Real, Lordelo, Portugal
Consorci Hospital General Universitari de València
🇪🇸Valencia, Spain
Sklifosovsky Scientific Research Institution of Emergency Care
🇷🇺Moscow, Russian Federation
Moscow Regional Research and Clinical Institute M.F. Vladimirsky
🇷🇺Moscow, Russian Federation
Kantonsspital St.Gallen Klinik für
🇨🇭St. Gallen, Saint Gallen, Switzerland
Universitaetsspital Bern Inselspital
🇨🇭Bern, Switzerland
Hospital Clínico Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Chia-Yi Christian Hospital
🇨🇳Chiayi City, Chiayi, Taiwan
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Synexus Hexham Clinical Research Centre
🇬🇧Hexham, United Kingdom
St James's University Hospital
🇬🇧Leeds, West Yorkshire, United Kingdom
Synexus Lancashire Clinical Research Centre
🇬🇧Lancaster, United Kingdom
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
Complejo Hospitalario Torrecardenas
🇪🇸Almeria, Spain
Praxis Driesener Strasse
🇩🇪Berlin, Germany
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Sheba Medical Center
🇮🇱Tel-Hashomer, Israel
East Tennessee Research Institute
🇺🇸Johnson City, Tennessee, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Centex Studies
🇺🇸Houston, Texas, United States
LinQ Research, LLC
🇺🇸Pearland, Texas, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, England, United Kingdom
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
The Institute for Liver Health
🇺🇸Chandler, Arizona, United States
Adobe Gastroenterology Research, LLC
🇺🇸Tucson, Arizona, United States
Del Sol Research Management, LLC
🇺🇸Tucson, Arizona, United States
Arkansas Diagnostic Center
🇺🇸Little Rock, Arkansas, United States
Del Sol Research Management LLC
🇺🇸Tucson, Arizona, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Southern California Research Center
🇺🇸Coronado, California, United States
eStudySite
🇺🇸La Mesa, California, United States
Citrus Valley Gastroenterology
🇺🇸Covina, California, United States
TriWest Research Associates
🇺🇸El Cajon, California, United States
Fresno Clinical Research Center (FCRC)
🇺🇸Fresno, California, United States
National Research Institute
🇺🇸Panorama City, California, United States
University of San Francisco, Fresno Medical Education Program
🇺🇸Fresno, California, United States
Om Research
🇺🇸Lancaster, California, United States
Alliance Clinical Research LLC
🇺🇸Poway, California, United States
Pasadena Liver Center
🇺🇸Pasadena, California, United States
Palmtree Clinical Research Inc.
🇺🇸Palm Springs, California, United States
Stanford School of Medicine, Center for Clinical Sciences Research
🇺🇸Redwood City, California, United States
Precision Research Institute
🇺🇸San Diego, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Upland Clinical Research
🇺🇸Upland, California, United States
Innovative Medical Research of South Florida, Inc.
🇺🇸Aventura, Florida, United States
Gastro Florida
🇺🇸Clearwater, Florida, United States
Top Medical Research, Inc
🇺🇸Cutler Bay, Florida, United States
Hi Tech and Global Research, LLC
🇺🇸Coral Gables, Florida, United States
ICR Sites
🇺🇸Doral, Florida, United States
Mayo Clinic College of Medicine
🇺🇸Jacksonville, Florida, United States
Gastroenterology Associates - Crystal River
🇺🇸Inverness, Florida, United States
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
South Denver Gastroenterology, PC
🇺🇸Englewood, Colorado, United States
Western States Clinical Research, Inc.
🇺🇸Wheat Ridge, Colorado, United States
Island View GI
🇺🇸Ventura, California, United States
Florida Digestive Health Specialists
🇺🇸Lakewood Ranch, Florida, United States
Clinical Pharmacology of Miami, LLC
🇺🇸Miami, Florida, United States
Advanced Research Institute, Inc.
🇺🇸New Port Richey, Florida, United States
Innovation Medical Research Center
🇺🇸Palmetto Bay, Florida, United States
Advanced Medical Research
🇺🇸Port Orange, Florida, United States
IMIC, Inc
🇺🇸Palmetto Bay, Florida, United States
Gastroenterology Associates of Pensacola
🇺🇸Pensacola, Florida, United States
Florida Medical Clinic
🇺🇸Zephyrhills, Florida, United States
Gastroenterology Associates of Central Georgia
🇺🇸Macon, Georgia, United States
GI Specialists of Georgia - Marietta Office
🇺🇸Marietta, Georgia, United States
Aquiant Research
🇺🇸New Albany, Indiana, United States
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Investigators Research Group, LLC
🇺🇸Brownsburg, Indiana, United States
Digestive Research Alliance of Michiana
🇺🇸South Bend, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
C-1 Headlands, Inc.
🇺🇸Lake Charles, Louisiana, United States
Tandem Clinical Research
🇺🇸New York, New York, United States
Kansas Medical Clinic-Gastroenterology
🇺🇸Topeka, Kansas, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Nola Research Works, LLC
🇺🇸New Orleans, Louisiana, United States
Louisiana Research Center
🇺🇸Shreveport, Louisiana, United States
Clinical Trials of America LLC
🇺🇸West Monroe, Louisiana, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Gastro Center of Maryland
🇺🇸Columbia, Maryland, United States
Umass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Meritus Center for Clinical Research
🇺🇸Hagerstown, Maryland, United States
Victory Clinical Research
🇺🇸Greenbelt, Maryland, United States
Lahey Hospital & Medical Center
🇺🇸Burlington, Massachusetts, United States
Minnesota Gastroenterology, P.A.
🇺🇸Maplewood, Minnesota, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
GastroIntestinal Associates
🇺🇸Flowood, Mississippi, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Northeast GI Research Division
🇺🇸Concord, North Carolina, United States
Digestive Disease Specialist, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Eastern Pennsylvania Gastroenterology and Liver Specialist
🇺🇸Bethlehem, Pennsylvania, United States
Care Access Research, Pottsville
🇺🇸Pottsville, Pennsylvania, United States
Partners in Clinical Research
🇺🇸Cumberland, Rhode Island, United States
University Medical Group
🇺🇸North Providence, Rhode Island, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Rapid City Medical Center
🇺🇸Rapid City, South Dakota, United States
Digestive Health Research
🇺🇸Lebanon, Tennessee, United States
UT-Memphis, Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Synexus
🇺🇸Dallas, Texas, United States
Digestive Health Associates of Texas-Rockwall
🇺🇸Garland, Texas, United States
Baylor Scott & White All Saints Medical Center - Ft. Worth
🇺🇸Fort Worth, Texas, United States
Therapeutic Concepts, PA
🇺🇸Houston, Texas, United States
San Antonio Military Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Texas Digestive Disease Consultants - Fort Worth
🇺🇸Fort Worth, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
Centex Studies, Inc.
🇺🇸McAllen, Texas, United States
McGuire Veterans Affairs Medical Center
🇺🇸Richmond, Virginia, United States
Texas Digestive Disease Consultants
🇺🇸Webster, Texas, United States
Gastroenterology Associates of Northern Virginia
🇺🇸Fairfax, Virginia, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Inova Fairfax Medical Campus
🇺🇸Falls Church, Virginia, United States
VCU Medical Center
🇺🇸Richmond, Virginia, United States
Advanced Clinical Research - Center for Digestive Health
🇺🇸Riverton, Utah, United States
Liver Institute of Virginia
🇺🇸Newport News, Virginia, United States
Gastroenterology Consultants of Southwest Virginia Research
🇺🇸Roanoke, Virginia, United States
Physician's Research Options, LLC
🇺🇸Draper, Utah, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Flinders Medical Center
🇦🇺Adelaide, South Australia, Australia
Saint George Hospital
🇦🇺Kogarah, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Hôpital Erasme
🇧🇪Bruxelles, Brussels, Belgium
Centre Hospitalier Chretien CHC
🇧🇪Liege, Belgium
Hospital Universitário Clementino Fraga Filho
🇧🇷Rio de Janeiro, Brazil
University of Calgary Liver Unit
🇨🇦Calgary, Alberta, Canada
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷Sao Paulo, Brazil
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
CHU de Montpellier
🇫🇷Montpellier cedex 5, Languedoc-Roussillon, France
Hapital Sud Service d'Hepato- Gastroentarologie
🇫🇷Amiens Cedex 1, Picardie, France
Hôpital Saint Antoine
🇫🇷Paris Cedex 12, Ile-de-France, France
Centre Hospitalier Universitaire de Nice Hôpital l'Archet
🇫🇷Nice Cedex 3, Provence Alpes Cote D'Azur, France
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Uniklinik RWTH Aachen
🇩🇪Aachen, Nordrhein-Westfalen, Germany
Uniklinik Köln
🇩🇪Köln, Nordrhein-westfalen, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany
Thomopoulos Gastroenterology Dept.
🇬🇷Patra, Peloponnese, Greece
Synexus Clinical Research GmbH, Prüfzentrum Berlin
🇩🇪Berlin, Germany
Universitätsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Charité Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Hippokratio Hospital
🇬🇷Thessaloniki, Greece
Somogy Megyei Kaposi Mór Oktató Kórház
🇭🇺Kaposvár, Somogy, Hungary
SYNEXUS Magyarország Kft. - Budapest DRS
🇭🇺Budapest, Hungary
EMMS MC
🇮🇱Nazareth, Jerusalem, Israel
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft
🇭🇺Debrecen, Hungary
Carmel Medical Center
🇮🇱Haifa, Israel
Rambam Health Care Campus - Rambam Medical Center
🇮🇱Haifa, Israel
Hadassah Medical Center, Institute of Gastroenterology and Liver Diseases
🇮🇱Jerusalem, Israel
Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Foggia, Italy
Rabin Medical Center Beilinson Hospital
🇮🇱Petah Tikva, Israel
Azienda Ospedaliera Universitaria Careggi SOD Medicina Interna ed Epatologia
🇮🇹Firenze, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
🇮🇹Palermo, Italy
Auckland City Hospital
🇳🇿Grafton, Auckland, New Zealand
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
Middlemore Clinical Trials
🇳🇿Papatoetoe, Auckland, New Zealand
Szpital Specjalistyczny Nr 1 w Bytomiu
🇵🇱Bytom, Slaskie, Poland
ID Clinic Arkadiusz Pisula
🇵🇱Myslowice, Slaskie, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni ul.
🇵🇱Gdynia, Poland
Synexus Polska Sp z o o Oddzial w Poznaniu
🇵🇱Poznań, Wielkopolska, Poland
Fundacion de Investigacion De Diego
🇵🇷San Juan, Puerto Rico
Clinical Research Puerto Rico
🇵🇷San Juan, Puerto Rico
Clinic Professor Gorbakova
🇷🇺Krasnogorsk, Moscow, Russian Federation
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
Hospital Universitario Ramón Y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Donostia
🇪🇸San Sebastian, Guipuzcoa, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitari Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario Nuestra Senora de Valme
🇪🇸Sevilla, Spain
Royal Stoke University Hospital
🇬🇧Stoke-on-Trent, England, United Kingdom
Barts Health NHS Trust The Royal London Hospital
🇬🇧London, United Kingdom
University Hospital of South Manchester NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Synexus Polska Sp. z o.o. Oddzial w Gdansku
🇵🇱Gdańsk, Poland
Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
🇵🇱Lódz, Lodzkie, Poland
Synexus Polska Sp. Z o.o. Oddzial w Czestochowie
🇵🇱Czestochowa, Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
🇵🇱Wrocław, Wroclaw, Poland
Yale University - New Haven
🇺🇸New Haven, Connecticut, United States
Bioclinical Research Alliance
🇺🇸Orlando, Florida, United States
Omega Research Maitland, LLC
🇺🇸Orlando, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Guardian Angel Research Center
🇺🇸Tampa, Florida, United States
Investigational Drug Service, The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
United Medical Doctors
🇺🇸Murrieta, California, United States
Objective GI D/B/A North Alabama GI Research Center
🇺🇸Madison, Alabama, United States
Royal Free London NHS Foundation Trust
🇬🇧London, England, United Kingdom
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Prince of Wales Hospital
🇭🇰Shatin, New Territories, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
🇭🇰Shatin, New Territories, Hong Kong