Clinical trial NCT03028740: AURORA: A Study for the Efficacy and Safety of Cenicriviroc (CVC) for the Treatment of Liver Fibrosis in Adults With Nonalcoholic Steatohepatitis (NASH)
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Nonalcoholic Steatohepatitis
Lead sponsor: Tobira Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-23
Enrollment: 1778
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage and No Worsening of Steatohepatitis on Liver Histology at Month 12
timeFrame: Month 12
measure: Time to First Occurrence of Adjudicated Events in the Full Study Cohort
timeFrame: From first dose of study drug to onset of first occurrence of the event (Up to approximately 42 months)
Secondary outcomes:
measure: 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
timeFrame: Month 12
measure: Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 1 Stage Regardless of Effect on Steatohepatitis at Month 12
timeFrame: Month 12
measure: Part 1: Percentage of Participants With Improvement in Fibrosis by at Least 2 Stages Regardless of Effect on Steatohepatitis at Month 12
timeFrame: Month 12
measure: 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
timeFrame: Month 12
measure: 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
timeFrame: Month 12
measure: 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
timeFrame: Month 12
measure: 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
timeFrame: Month 12
measure: 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
timeFrame: Month 60
measure: 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
timeFrame: Month 60
measure: 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
timeFrame: Month 60
measure: 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
timeFrame: Month 60
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Summit Internal Medicine
state: Alabama
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Madison
country: United States
facility: Objective GI D/B/A North Alabama GI Research Center
state: Alabama
city: Chandler
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Tucson
country: United States
facility: Adobe Gastroenterology Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management LLC
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Diagnostic Center
state: Arkansas
city: Bakersfield
country: United States
facility: Franco Felizarta MD
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Chula Vista
country: United States
facility: GW Research
state: California
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Covina
country: United States
facility: Citrus Valley Gastroenterology
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates
state: California
city: Fresno
country: United States
facility: University of San Francisco, Fresno Medical Education Program
state: California
city: Fresno
country: United States
facility: Fresno Clinical Research Center (FCRC)
state: California
city: Huntington Park
country: United States
facility: National Research Institute
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: La Mesa
country: United States
facility: eStudySite
state: California
city: Lancaster
country: United States
facility: Om Research
state: California
city: Los Angeles
country: United States
facility: Southern California Kaiser Permanente, Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: GastroIntestinal Biosciences
state: California
city: Los Angeles
country: United States
facility: Global Research Institute
state: California
city: Los Angeles
country: United States
facility: Ruane Medical and Liver Health Institute
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Group
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research Inc.
state: California
city: Panorama City
country: United States
facility: National Research Institute
state: California
city: Pasadena
country: United States
facility: Pasadena Liver Center
state: California
city: Poway
country: United States
facility: Alliance Clinical Research LLC
state: California
city: Redwood City
country: United States
facility: Stanford School of Medicine, Center for Clinical Sciences Research
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: San Diego
country: United States
facility: Southern California Permanente Medical Group
state: California
city: San Francisco
country: United States
facility: UCSF School of Medicine
state: California
city: Upland
country: United States
facility: Upland Clinical Research
state: California
city: Ventura
country: United States
facility: Island View GI
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology, PC
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research, Inc.
state: Colorado
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County
state: Connecticut
city: New Haven
country: United States
facility: Yale University - New Haven
state: Connecticut
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida, Inc.
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Coral Gables
country: United States
facility: Hi Tech and Global Research, LLC
state: Florida
city: Cutler Bay
country: United States
facility: Top Medical Research, Inc
state: Florida
city: Doral
country: United States
facility: ICR Sites
state: Florida
city: Hialeah
country: United States
facility: Qway Research, LLC
state: Florida
city: Inverness
country: United States
facility: Gastroenterology Associates - Crystal River
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic College of Medicine
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Digestive Health Specialists
state: Florida
city: Maitland
country: United States
facility: Meridien Research
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, LLC
state: Florida
city: Miami
country: United States
facility: Bruce W. Carter Department of Veterans Affairs Medical Center
state: Florida
city: Miami
country: United States
facility: Optimus U Corporation
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research, Inc
state: Florida
city: Miami
country: United States
facility: Genoma Research Group Inc.
state: Florida
city: Miami
country: United States
facility: Medical Professional Clinical Research Center, INC
state: Florida
city: Miami
country: United States
facility: ProLive Medical Research
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Orlando
country: United States
facility: Bioclinical Research Alliance
state: Florida
city: Orlando
country: United States
facility: Omega Research Maitland, LLC
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC, Inc
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Pensacola
country: United States
facility: Gastroenterology Associates of Pensacola
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Guardian Angel Research Center
state: Florida
city: The Villages
country: United States
facility: Bioclinica Research
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic
state: Florida
city: Athens
country: United States
facility: Summit Clinical Research, LLC
state: Georgia
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia - Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Healthcare INC.
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Marietta
country: United States
facility: GI Specialists of Georgia - Marietta Office
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Brownsburg
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: New Albany
country: United States
facility: Aquiant Research
state: Indiana
city: South Bend
country: United States
facility: Digestive Research Alliance of Michiana
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Topeka
country: United States
facility: Kansas Medical Clinic-Gastroenterology
state: Kansas
city: Bastrop
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Crowley
country: United States
facility: Avant Research Associates LLC
state: Louisiana
city: Lake Charles
country: United States
facility: C-1 Headlands, Inc.
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Nola Research Works, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center
state: Louisiana
city: West Monroe
country: United States
facility: Clinical Trials of America LLC
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Catonsville
country: United States
facility: Digestive Disease Associates
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Glen Burnie
country: United States
facility: Woodholme Gastroenterology Associates
state: Maryland
city: Greenbelt
country: United States
facility: Victory Clinical Research
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: Umass Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Maplewood
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Biloxi
country: United States
facility: National Diabetes and Obesity Research Institute
state: Mississippi
city: Flowood
country: United States
facility: GastroIntestinal Associates
state: Mississippi
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Machuca Family Medicine
state: Nevada
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Raritan
country: United States
facility: Amici Clinical Research
state: New Jersey
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: NYU Langone Health - Perlmutter Cancer Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Tandem Clinical Research
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Chapel Hill
country: United States
facility: Investigational Drug Service, The University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Concord
country: United States
facility: Northeast GI Research Division
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Greenville
country: United States
facility: Carolina Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio University - Gastroenterology, Hepatology
state: Ohio
city: Oklahoma City
country: United States
facility: Digestive Disease Specialist, Inc.
state: Oklahoma
city: Tulsa
country: United States
facility: Options Health Research
state: Oklahoma
city: Bethlehem
country: United States
facility: Eastern Pennsylvania Gastroenterology and Liver Specialist
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC -Center for Liver Diseases
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Pottsville
country: United States
facility: Care Access Research, Pottsville
state: Pennsylvania
city: Wyomissing
country: United States
facility: Digestive Disease Associates, LTD
state: Pennsylvania
city: Cumberland
country: United States
facility: Partners in Clinical Research
state: Rhode Island
city: North Providence
country: United States
facility: University Medical Group
state: Rhode Island
city: Warwick
country: United States
facility: Care Access Research-Warwick
state: Rhode Island
city: Rapid City
country: United States
facility: Rapid City Medical Center
state: South Dakota
city: Chattanooga
country: United States
facility: Mount Vernon Clinical Research
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Hermitage
country: United States
facility: Digestive Health Research
state: Tennessee
city: Johnson City
country: United States
facility: East Tennessee Research Institute
state: Tennessee
city: Lebanon
country: United States
facility: Digestive Health Research
state: Tennessee
city: Memphis
country: United States
facility: UT-Memphis, Methodist University Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: Liver Center of Texas
state: Texas
city: Dallas
country: United States
facility: Synexus
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott & White All Saints Medical Center - Ft. Worth
state: Texas
city: Fort Worth
country: United States
facility: Texas Digestive Disease Consultants - Fort Worth
state: Texas
city: Garland
country: United States
facility: Digestive Health Associates of Texas-Rockwall
state: Texas
city: Houston
country: United States
facility: Therapeutic Concepts, PA
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center (MEDVAMC)
state: Texas
city: Houston
country: United States
facility: St. Luke's Medical Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Centex Studies
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Amir Ali Hassan, MD, PA
state: Texas
city: McAllen
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Pearland
country: United States
facility: LinQ Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic, P.A. (DGD)
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC SAGACT PLLC.
state: Texas
city: San Antonio
country: United States
facility: Anson Medicine
state: Texas
city: Sugar Land
country: United States
facility: Mount Olympus Medical Research, LLC
state: Texas
city: Webster
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Draper
country: United States
facility: Physician's Research Options, LLC
state: Utah
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Riverton
country: United States
facility: Advanced Clinical Research - Center for Digestive Health
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Fairfax
country: United States
facility: Gastroenterology Associates of Northern Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Newport News
country: United States
facility: Liver Institute of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: McGuire Veterans Affairs Medical Center
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
city: Roanoke
country: United States
facility: Gastroenterology Consultants of Southwest Virginia Research
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: Liver Institute Northwest
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Huntington
country: United States
facility: Marshall University Joan C. Edwards School of Medicine
state: West Virginia
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: Saint George Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Adelaide
country: Australia
facility: Flinders Medical Center
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Graz
country: Austria
facility: Universitatsklinik far Innere Medizin
state: Styria
city: Innsbruck
country: Austria
facility: Universitatsklinik far Innere Medizin II
state: Tyrol
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
state: Upper Austria
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
state: Antwerpen
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
state: Brussels
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Liege
country: Belgium
facility: Centre Hospitalier Chretien CHC
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas da Universidade Federal de Minas Gerais
state: Minas Gerais
city: São José do Rio Preto
country: Brazil
facility: Faculdade de Medicina de São José do Rio Preto Hospital de Base
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
city: Calgary
country: Canada
facility: University of Calgary Liver Unit
state: Alberta
city: Edmonton
country: Canada
facility: Bailey Health Clinic
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Brampton
country: Canada
facility: William Osler Health Centre, Brampton Memorial Hospital Campus
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Viña del Mar
country: Chile
facility: Centro de Investigaciones Clínicas Viña del Mar
state: Valparaiso
city: Strasbourg cedex
country: France
facility: CHU de Strasbourg
state: Alsace
city: Pessac
country: France
facility: CHU De Bordeaux - Hôpital Haût-Lévèque CMC Magellan Unita de Recherche Clinique
state: Aquitaine
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire Estaing
state: Aubergne
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes- Hôpital Pontchaillou
state: Bretagne
city: Besançon cedex
country: France
facility: Centre Hospitalier Regional et Universitaire de Besancon - L'Hopital Jean Minjoz
state: Franche-Comte
city: Clichy
country: France
facility: Departement d'Hacpatologie
state: Ile-De-France
city: Paris Cedex 12
country: France
facility: Hôpital Saint Antoine
state: Ile-de-France
city: Montpellier cedex 5
country: France
facility: CHU de Montpellier
state: Languedoc-Roussillon
city: Rouen
country: France
facility: Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle
state: Normandie
city: Angers
country: France
facility: Center Hospitalier Universitaire d'Angers
state: Pays De La Loire
city: Amiens Cedex 1
country: France
facility: Hapital Sud Service d'Hepato- Gastroentarologie
state: Picardie
city: Nice Cedex 3
country: France
facility: Centre Hospitalier Universitaire de Nice Hôpital l'Archet
state: Provence Alpes Cote D'Azur
city: Grenoble Cedex 09
country: France
facility: Centre Hospitalier Universitaire Grenoble
state: Rhone-Alpes
city: Bobigny
country: France
facility: Hopital Avicenne
city: Frankfurt
country: Germany
facility: Synexus Clinical Research GmbH, Prüfzentrum Frankfurt
state: Hessen
city: Marburg
country: Germany
facility: Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Herne
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis
state: Nordhein-Westfalen
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Uniklinik Köln
state: Nordrhein-westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz
state: Rheinland-Pfalz
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Berlin
country: Germany
facility: Praxis Driesener Strasse
city: Berlin
country: Germany
facility: Synexus Clinical Research GmbH, Prüfzentrum Berlin
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Patra
country: Greece
facility: Thomopoulos Gastroenterology Dept.
state: Peloponnese
city: Thessaloniki
country: Greece
facility: Hippokratio Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: New Territories
city: Shatin
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
state: New Territories
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
state: Somogy
city: Budapest
country: Hungary
facility: SYNEXUS Magyarország Kft. - Budapest DRS
city: Debrecen
country: Hungary
facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft
city: Nazareth
country: Israel
facility: EMMS MC
state: Jerusalem
city: Haifa
country: Israel
facility: Rambam Health Care Campus - Rambam Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center, Institute of Gastroenterology and Liver Diseases
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel-Hashomer
country: Israel
facility: Sheba Medical Center
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
state: Foggia
city: Milan
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: Milano
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi SOD Medicina Interna ed Epatologia
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
city: Roma
country: Italy
facility: Fondazione Policlinico Tor Vergata
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Mexico
country: Mexico
facility: Consultorio Médico Dr. Alma Laura Ladron de Guevara
state: Distrito Federal
city: Cuernavaca
country: Mexico
facility: JM Research - Cuernavaca
state: Morelos
city: Monterrey
country: Mexico
facility: Investigaciones Medicas Cisneros
state: Nuevo Leon
city: Metepec
country: Mexico
facility: Consultorio Dra. Maria Sarai Gonzalez Huezo
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Auckland
city: Papatoetoe
country: New Zealand
facility: Middlemore Clinical Trials
state: Auckland
city: Oslo
country: Norway
facility: Oslo Universitetssykehus-Ullevål
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny
state: Dolnoslaskie
city: Lódz
country: Poland
facility: Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
state: Lodzkie
city: Łódź
country: Poland
facility: Synexus Polska Sp. z o.o. Oddział w Łodzi
state: Lodz
city: Bytom
country: Poland
facility: Szpital Specjalistyczny Nr 1 w Bytomiu
state: Slaskie
city: Myslowice
country: Poland
facility: ID Clinic Arkadiusz Pisula
state: Slaskie
city: Poznań
country: Poland
facility: Synexus Polska Sp z o o Oddzial w Poznaniu
state: Wielkopolska
city: Wrocław
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
state: Wroclaw
city: Czestochowa
country: Poland
facility: Synexus Polska Sp. Z o.o. Oddzial w Czestochowie
city: Gdańsk
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni ul.
city: Katowice
country: Poland
facility: Synexus SCM Sp. z o.o. Oddzial
city: Warsaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddział w Warszawie
city: Vila Real
country: Portugal
facility: Presa-Ramos
state: Lordelo
city: Viana do Castelo
country: Portugal
facility: Unidade Local de Saúde do Alto Minho
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion De Diego
city: Cluj-Napoca
country: Romania
facility: Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor
state: Cluj
city: Krasnogorsk
country: Russian Federation
facility: Clinic Professor Gorbakova
state: Moscow
city: Moscow
country: Russian Federation
facility: Sklifosovsky Scientific Research Institution of Emergency Care
city: Moscow
country: Russian Federation
facility: Moscow Regional Research and Clinical Institute M.F. Vladimirsky
city: Singapore
country: Singapore
facility: National University Hospital
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia
state: Guipuzcoa
city: Almeria
country: Spain
facility: Complejo Hospitalario Torrecardenas
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebrón
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Ramón Y Cajal
city: Málaga
country: Spain
facility: Hospital Clínico Universitario Virgen de la Victoria
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Senora de Valme
city: Valencia
country: Spain
facility: Consorci Hospital General Universitari de València
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: St. Gallen
country: Switzerland
facility: Kantonsspital St.Gallen Klinik für
state: Saint Gallen
city: Bern
country: Switzerland
facility: Universitaetsspital Bern Inselspital
city: Chiayi City
country: Taiwan
facility: Chia-Yi Christian Hospital
state: Chiayi
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: Taichung City
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-LinKou Branch
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: England
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
state: England
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
state: England
city: Luton
country: United Kingdom
facility: Luton and Dunstable Hospital NHS Foundation Trust
state: England
city: Newcastle
country: United Kingdom
facility: Newcastle Upon the Tyne Hospitals
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham Digestive Diseases Biomedical Research Unit
state: England
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
state: England
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
state: England
city: Leeds
country: United Kingdom
facility: St James's University Hospital
state: West Yorkshire
city: Hexham
country: United Kingdom
facility: Synexus Hexham Clinical Research Centre
city: Lancaster
country: United Kingdom
facility: Synexus Lancashire Clinical Research Centre
city: London
country: United Kingdom
facility: Barts Health NHS Trust The Royal London Hospital
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester NHS Foundation Trust
Study officials:
affiliation: Allergan
name: Gerardo Rodriguez
role: STUDY_DIRECTOR
References: