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AURORA: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03028740
Recruitment Status : Terminated (This study was terminated early due to lack of efficacy based on the results of Part I of the AURORA study.)
First Posted : January 23, 2017
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
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 subjects with NASH.

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Drug: Cenicriviroc Drug: Placebo Phase 3

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. Subjects from Part 1 will continue into Part 2 and additional subjects 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1779 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: AURORA: A Phase 3 Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : January 5, 2021
Actual Study Completion Date : January 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug: Cenicriviroc
150 mg cenicriviroc
Drug: Cenicriviroc
1 tablet QD
Other Name: CVC

Placebo Comparator: Drug: Placebo
Placebo
Drug: Placebo
1 tablet QD




Primary Outcome Measures :
  1. Superiority of CVC compared to placebo on liver histology at Month 12 relative to the Screening biopsy [ Time Frame: Measurements at Baseline and 12 months ]
    Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) AND no worsening of steatohepatitis

  2. Superiority of CVC compared to placebo on the composite endpoint of histopathologic progression to cirrhosis, liver-related clinical outcomes, and all-cause mortality [ Time Frame: Time to accrue a pre-specified number of adjudicated events, End of Study, estimated to be 5 years ]

Secondary Outcome Measures :
  1. Effect of CVC compared to placebo on liver histology at Month 60 relative to the Screening biopsy for the proportion of subjects with improvement in fibrosis by at least 1 stage AND no worsening of steatohepatitis [ Time Frame: Time to accrue a pre-specified number of adjudicated events, End of Study, estimated to be 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects 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
  • Subjects included in Part1 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. Subjects 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 mU/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
  • AST > 200 IU/L in males and females at Screening
  • ALT > 250 IU/L in males and > 200 IU/L in females at Screening
  • HbA1c > 10% at Screening
  • Serum albumin < 3.5 g/dL at Screening
  • Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease (MDRD) equation
  • Platelet count < 100,000/mm3
  • Total bilirubin > 1.5 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 SGLT1 inhibitor, or a thiazolidinedione (TZD) for less than 6 months prior to the Screening period liver biopsy. Subjects 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, subjects need to be on stable therapy for at least 6 months prior to the day historical liver biopsy was performed).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028740


Locations
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United States, Alabama
Summit Internal Medicine
Birmingham, Alabama, United States, 35243
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0012
Cullman Clinical Trials
Cullman, Alabama, United States, 35055
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States, 36305
Objective GI D/B/A North Alabama GI Research Center
Madison, Alabama, United States, 35758
United States, Arizona
The Institute for Liver Health
Chandler, Arizona, United States, 85224-5688
Adobe Gastroenterology Research, LLC
Tucson, Arizona, United States, 85712
Del Sol Research Management, LLC
Tucson, Arizona, United States, 85712
Del Sol Research Management LLC
Tucson, Arizona, United States, 85745
United States, Arkansas
ARcare Center for Clinical Research
Augusta, Arkansas, United States, 72006
Arkansas Diagnostic Center
Little Rock, Arkansas, United States, 72205
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
United States, California
Franco Felizarta MD
Bakersfield, California, United States, 93301
Hope Clinical Research, Inc.
Canoga Park, California, United States, 91303
GW Research
Chula Vista, California, United States, 91910
Precision Research Institute
Chula Vista, California, United States, 92114
Southern California Research Center
Coronado, California, United States, 92118
Citrus Valley Gastroenterology
Covina, California, United States, 91722
University of San Francisco, Fresno Medical Education Program
Fresno, California, United States, 93701
Fresno Clinical Research Center (FCRC)
Fresno, California, United States, 93720
National Research Institute
Huntington Park, California, United States, 90255
University of California San Diego
La Jolla, California, United States, 92037
Irvine Center for Clinical Research 067
La Jolla, California, United States, 92093-0698
eStudySite
La Mesa, California, United States, 91942
Om Research
Lancaster, California, United States, 93534
Southern California Kaiser Permanente, Los Angeles Medical Center
Los Angeles, California, United States, 90027
Global Research Institute
Los Angeles, California, United States, 90036
Ruane Medical and Liver Health Institute
Los Angeles, California, United States, 90036
Cedars-Sinai Medical Group
Los Angeles, California, United States, 90048
National Research Institute
Los Angeles, California, United States, 90057
GastroIntestinal Biosciences
Los Angeles, California, United States, 90067-2015
Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
United Medical Doctors
Murrieta, California, United States, 92563
eStudySite
Oceanside, California, United States, 91911-6660
Odyssey Clinical Research, LLC
Orange, California, United States, 92866
Palmtree Clinical Research Inc.
Palm Springs, California, United States, 92262
Stanford School of Medicine, Center for Clinical Sciences Research
Palo Alto, California, United States, 94304
Asclepes Research Centers
Panorama City, California, United States, 91402
National Research Institute
Panorama City, California, United States, 91402
Pasadena Liver Center
Pasadena, California, United States, 91105
Dream Team Clinical Research
Pomona, California, United States, 91767
Alliance Clinical Research
Poway, California, United States, 92064
Inland Empire Liver Foundation
Rialto, California, United States, 92377-4697
UC Davis Medical Center
Sacramento, California, United States, 95817
UC Davis
Sacramento, California, United States, 95817
TriWest Research Associates
San Diego, California, United States, 92020
Precision Research Institute
San Diego, California, United States, 92114
Southern California Permanente Medical Group
San Diego, California, United States, 92154
Quest Clinical Research
San Francisco, California, United States, 94115
UCSF School of Medicine
San Francisco, California, United States, 94143-0538
Care Access Research LLC
San Pablo, California, United States, 94806
Upland Clinical Research
Upland, California, United States, 91786
Island View GI
Ventura, California, United States, 93003
United States, Colorado
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
South Denver Gastroenterology, PC
Englewood, Colorado, United States, 80113
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States, 06606
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States, 06518
Yale University - New Haven
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Medstar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
Innovative Medical Research of South Florida, Inc.
Aventura, Florida, United States, 33180
Xera Med Research
Boca Raton, Florida, United States, 33478
Gastroenterology Consultants of Clearwater
Clearwater, Florida, United States, 33756-3839
West Central Gatroenterology
Clearwater, Florida, United States, 33761
All Medical Research, LLC
Cooper City, Florida, United States, 33024
Hi Tech and Global Research, LLC
Coral Gables, Florida, United States, 33134
Top Medical Research, Inc
Cutler Bay, Florida, United States, 33189
ICR Sites
Doral, Florida, United States, 33166
Qway Research, LLC
Hialeah, Florida, United States, 33010
Direct Helpers Research Center
Hialeah, Florida, United States, 33012
Palmetto Research, LLC
Hialeah, Florida, United States, 33016
Gastroenterology Associates - Crystal River
Inverness, Florida, United States, 34452
Mayo Clinic College of Medicine
Jacksonville, Florida, United States, 32224
SIH Research LLC
Kissimmee, Florida, United States, 34741
Meridien Research
Lakeland, Florida, United States, 33805
Florida Digestive Health Specialists
Lakewood Ranch, Florida, United States, 34211
ClinCloud, LLC
Maitland, Florida, United States, 32751
Meridien Research
Maitland, Florida, United States, 32751
Southwest Gastroenterology
Maitland, Florida, United States, 32751
San Marcus Research Clinic
Miami Lakes, Florida, United States, 33014
Clinical Pharmacology of Miami, LLC
Miami, Florida, United States, 33014
Bruce W. Carter Department of Veterans Affairs Medical Center
Miami, Florida, United States, 33125
Optimus U Corporation
Miami, Florida, United States, 33125
University of Miami Hospital
Miami, Florida, United States, 33136
Invictus Clinical Research Group LLC
Miami, Florida, United States, 33144
Regenerate Clinical Trials
Miami, Florida, United States, 33155-6553
Gastroenterology Associates of Western Colorado
Miami, Florida, United States, 33157
Sanchez Clinical Research, Inc
Miami, Florida, United States, 33157
Genoma Research Group Inc.
Miami, Florida, United States, 33165
Medical Professional Clinical Research Center, INC
Miami, Florida, United States, 33165
Clinical Research Associates of South Florida
Miami, Florida, United States, 33172
ProLive Medical Research
Miami, Florida, United States, 33175
Med Research of Florida, LLC
Miami, Florida, United States, 33186
Advanced Research Institute, Inc.
New Port Richey, Florida, United States, 34653
Orlando Immunology Center
Orlando, Florida, United States, 32803
Bioclinical Research Alliance
Orlando, Florida, United States, 32806
Omega Research Maitland, LLC
Orlando, Florida, United States, 32810
Innovation Medical Research Center
Palmetto Bay, Florida, United States, 33157
Gastroenterology Associates of Pensacola
Pensacola, Florida, United States, 32503
Advanced Medical Research
Port Orange, Florida, United States, 32127
Advanced Research Institute, Inc
Saint Petersburg, Florida, United States, 33710
Sensible Healthcare
Summerfield, Florida, United States, 34491
Tampa General Hospital
Tampa, Florida, United States, 33606
AdventHealth Tampa
Tampa, Florida, United States, 33613
Guardian Angel Research Center
Tampa, Florida, United States, 33614
Gastro Florida
Tampa, Florida, United States, 33626
Bioclinica Research
The Villages, Florida, United States, 32162
South Florida Center of Gastroenterology, PA
Wellington, Florida, United States, 33414
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Florida Medical Clinic
Zephyrhills, Florida, United States, 33542
United States, Georgia
Summit Clinical Research, LLC
Athens, Georgia, United States, 30607
Consultative Gastroenterology
Atlanta, Georgia, United States, 30308
Digestive Healthcare of Georgia - Atlanta
Atlanta, Georgia, United States, 30309
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
WellStar Health System
Atlanta, Georgia, United States, 30312
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States, 31201
GI Specialists of Georgia - Marietta Office
Marietta, Georgia, United States, 30060
Infinite Clinical Trials
Riverdale, Georgia, United States, 30274
Digestive Disease Specialist, Inc.
Snellville, Georgia, United States, 30078
United States, Idaho
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
RxClinicals
Crystal Lake, Illinois, United States, 60012
Georgia Clinical Research LLC
New Lenox, Illinois, United States, 60451
Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Indiana
Investigators Research Group, LLC
Brownsburg, Indiana, United States, 46112
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States, 46143
Aquiant Research
New Albany, Indiana, United States, 47150
Digestive Research Alliance of Michiana
South Bend, Indiana, United States, 46635
United States, Iowa
Iowa Digestive Disease Center
Clive, Iowa, United States, 50325
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Kansas Medical Clinic-Gastroenterology
Topeka, Kansas, United States, 66606
United States, Kentucky
University of Louisville Physicians - University Medical Associates (UMA)
Louisville, Kentucky, United States, 40202
United States, Louisiana
Delta Research Partners, LLC
Bastrop, Louisiana, United States, 71220
Gastroenterology Associates of Central Georgia
Bastrop, Louisiana, United States, 71220
Avant Research Associates LLC
Crowley, Louisiana, United States, 70526
Centex Studies, Inc.
Lake Charles, Louisiana, United States, 70601
Tandem Clinical Research
Marrero, Louisiana, United States, 70072
New Orleans Research Institute
Metairie, Louisiana, United States, 70006
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
Nola Research Works, LLC
New Orleans, Louisiana, United States, 70125
Louisiana Research Center
Shreveport, Louisiana, United States, 71105
Clinical Trials of America LA LLC
West Monroe, Louisiana, United States, 71291
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Digestive Disease Associates
Catonsville, Maryland, United States, 21228
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Gastro Center of Maryland
Columbia, Maryland, United States, 21045
Woodholme Gastroenterology - Severn
Glen Burnie, Maryland, United States, 21061
Victory Clinical Research
Greenbelt, Maryland, United States, 20770
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Medical Center
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
The Research Institute
Springfield, Massachusetts, United States, 01105
Umass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Minnesota Gastroenterology
Maplewood, Minnesota, United States, 55117
United States, Mississippi
National Diabetes and Obesity Research Institute
Biloxi, Mississippi, United States, 39532
GastroIntestinal Associates
Flowood, Mississippi, United States, 39232
United States, Missouri
Clinical Research Professionals
Creve Coeur, Missouri, United States, 63141
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
Saint Louis University
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105
United States, Nevada
Machuca Family Medicine
Las Vegas, Nevada, United States, 89104
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, United States, 89106
Sierra Clinical Research
Las Vegas, Nevada, United States, 89106
Excel Clinical Research
Las Vegas, Nevada, United States, 89109
Las Vegas Medical Research
Las Vegas, Nevada, United States, 89113
Advanced Biomedical Research of America
Las Vegas, Nevada, United States, 89123
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
Garden State Endocrinology LLC
Brick, New Jersey, United States, 08723
AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey, United States, 08234
Amici Clinical Research
Martinsville, New Jersey, United States, 08836
Rutgers University New Jersey Medical School
Newark, New Jersey, United States, 07103
Coastal Healthcare
Ocean Township, New Jersey, United States, 07712
United States, New York
New York Clinical Trials
Brooklyn, New York, United States, 11201
The State University of New York, University at Buffalo
Buffalo, New York, United States, 14201
Sing Chan, MD
Flushing, New York, United States, 11355
United Health Services Hospitals, Inc
Johnson City, New York, United States, 13790
Beth Israel Medical Center
New York, New York, United States, 10003
NYU Langone Health - Perlmutter Cancer Center
New York, New York, United States, 10016
Weill Cornell Medical College
New York, New York, United States, 10021
Mount Sinai Medical Center
New York, New York, United States, 10029
Tandem Clinical Research
New York, New York, United States, 10033
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Northeast GI Research Division
Concord, North Carolina, United States, 28027
Duke University
Durham, North Carolina, United States, 27710
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States, 28304
Carolina Research
Greenville, North Carolina, United States, 27834
Wake Research Associates
Raleigh, North Carolina, United States, 27612
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45249
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Endocrinology Research Associates
Columbus, Ohio, United States, 43201
The Ohio University - Gastroenterology, Hepatology
Columbus, Ohio, United States, 43210
Gastroenterology Research of Lima
Lima, Ohio, United States, 45806
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
IMIC, Inc.
Oklahoma City, Oklahoma, United States, 73112
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
Options Health Research
Tulsa, Oklahoma, United States, 74104
Gastroenterology Specialists, Inc.
Tulsa, Oklahoma, United States, 74135
Adult Gastroenterology Associates-Gen1 Research
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Main Line Gastroenterology Associates, P.C.
Bala-Cynwyd, Pennsylvania, United States, 19004
Eastern Pennsylvania Gastroenterology and Liver Specialist
Bethlehem, Pennsylvania, United States, 18017
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
UPMC -Center for Liver Diseases
Pittsburgh, Pennsylvania, United States, 15213
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
Care Access Research, Pottsville
Pottsville, Pennsylvania, United States, 17901
Digestive Disease Associates, LTD
Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island
Partners in Clinical Research
Cumberland, Rhode Island, United States, 02864
University Medical Group
North Providence, Rhode Island, United States, 02908
University Gastroenterology
Providence, Rhode Island, United States, 02905
Care Access Research-Warwick
Warwick, Rhode Island, United States, 02886
United States, South Dakota
Rapid City Medical Center
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Mount Vernon Clinical Research
Chattanooga, Tennessee, United States, 37421
Gastro One
Germantown, Tennessee, United States, 38138
Digestive Health Research
Hermitage, Tennessee, United States, 37076
East Tennessee Research Institute
Johnson City, Tennessee, United States, 37604
Digestive Health Research
Lebanon, Tennessee, United States, 37090
UT-Memphis, Methodist University Hospital
Memphis, Tennessee, United States, 38104
Vanderbilt University
Nashville, Tennessee, United States, 37232-5280
United States, Texas
Texas Clinical Research Institute
Arlington, Texas, United States, 76012
Avant Research Associates
Austin, Texas, United States, 78704
Clinical Trials of Texas Inc
Austin, Texas, United States, 78733
Austin Center for Clinical Research
Austin, Texas, United States, 78758
Trinity Universal Research Associates, Inc
Carrollton, Texas, United States, 75007
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Dallas Diabetes Research Center
Dallas, Texas, United States, 75230
Meritus Center for Clinical Research
Dallas, Texas, United States, 75230
Liver Center of Texas
Dallas, Texas, United States, 75234
Southwest Family Medicine Associates
Dallas, Texas, United States, 75235
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8887
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78234
Baylor Scott & White All Saints Medical Center - Ft. Worth
Fort Worth, Texas, United States, 76104
Texas Digestive Disease Consultants - Fort Worth
Fort Worth, Texas, United States, 76104
Therapeutic Concepts, PA
Houston, Texas, United States, 77004
Kelsey Research Foundation
Houston, Texas, United States, 77025
Liver Associates of Texas
Houston, Texas, United States, 77030-3002
Baylor College of Medicine
Houston, Texas, United States, 77030
Michael E. DeBakey VA Medical Center (MEDVAMC)
Houston, Texas, United States, 77030
St. Luke's Medical Center
Houston, Texas, United States, 77030
Biopharma Informatic, LLC
Houston, Texas, United States, 77043
Centex Studies
Houston, Texas, United States, 77058
Biopharma Informatic, LLC
Houston, Texas, United States, 77084
Amir A. Hassan, MD, PA
Houston, Texas, United States, 77089
Pioneer Research Solutions, Inc.
Houston, Texas, United States, 77099
GI Specialists of Houston
Humble, Texas, United States, 77346
Pinnacle Clinical Research
Live Oak, Texas, United States, 78233
Rio Grande Gastroenterology
McAllen, Texas, United States, 78503
Centex Studies, Inc.
McAllen, Texas, United States, 78504
LinQ Research, LLC
Pearland, Texas, United States, 77584
ClinRx Research LLC
Plano, Texas, United States, 75024
Synexus Clinical Research
Plano, Texas, United States, 75093
Digestive Health Associates of Texas-Rockwall
Richardson, Texas, United States, 75082
American Research Corporation
San Antonio, Texas, United States, 77030
Quality Research Inc.
San Antonio, Texas, United States, 78209
American Research Corporation
San Antonio, Texas, United States, 78215
San Antonio Premier Internal Medicine
San Antonio, Texas, United States, 78220
Diabetes & Glandular Disease Clinic, P.A. (DGD)
San Antonio, Texas, United States, 78229
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States, 78229
Sagact Pllc
San Antonio, Texas, United States, 78229
Anson Medicine
San Antonio, Texas, United States, 78260
Texas Digestive Disease Consultants
Southlake, Texas, United States, 76092
Gastrointestinal and Liver disease consultants
Sugar Land, Texas, United States, 77479
Mount Olympus Medical Research, LLC
Sugar Land, Texas, United States, 77479
Texas Digestive Disease Consultants
Webster, Texas, United States, 77598
United States, Utah
Physician's Research Options, LLC
Draper, Utah, United States, 84020
Intermountain Medical Center
Murray, Utah, United States, 84107
Care Access Research, LLC
Ogden, Utah, United States, 84403
Advanced Clinical Research - Center for Digestive Health
Riverton, Utah, United States, 84065
Care Access Research LLC
Salt Lake City, Utah, United States, 84124
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Health Systems
Charlottesville, Virginia, United States, 22908
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, United States, 22031-4652
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Liver Institute of Virginia
Newport News, Virginia, United States, 23602
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States, 23249
VCU Medical Center
Richmond, Virginia, United States, 23298
Digestive Disease Care PC
Roanoke, Virginia, United States, 24014
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, United States, 24014
United States, Washington
Virginia Mason Hospital
Seattle, Washington, United States, 98101
Harborview Medical Center
Seattle, Washington, United States, 98104
Swedish Medical Center
Seattle, Washington, United States, 98104
Liver Institute Northwest
Seattle, Washington, United States, 98105
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, West Virginia
Marshall University Department of Clinical and Translational Sciences
Huntington, West Virginia, United States, 25701
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-7375
Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina, B1629AHJ
DIM Clinica Privada
Ramos Mejia, Buenos Aires, Argentina, B1704ETD
Hospital Provincial del Centenario
Rosario, Santa Fe, Argentina, 2000
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Saint George Hospital
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia, 4120
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Flinders Medical Center
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Austin Health
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Austria
Medizinische Universität Graz
Graz, Styria, Austria, 8036
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria, 6020
Klinikum Wels-Grieskirchen
Wels, Upper Austria, Austria, 4600
Wilhelminenspital der Stadt Wien
Wien, Vienna, Austria, A-1160
Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, Belgium, 2650
Algemeen Ziekenhuis Maria Middelares
Gent, Oost-Vlaanderen, Belgium, 9000
Universitair Ziekenhuis Gent
Gent, Oost-Vlaanderen, Belgium, 9000
Hôpital Erasme
Brussels, Belgium, 1070
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
UZ Leuven
Leuven, Belgium, 3000
Centre Hospitalier Chretien CHC
Liege, Belgium, 4000
Brazil
Hospital São Rafael-Monte Tabor
Salvador, Bahia, Brazil, 41253-190
Hospital das Clínicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Hospital das Clínicas da Faculdade de Medicina da Riberao Preto da Universidade de São Paulo
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
Faculdade de Medicina de São José do Rio Preto Hospital de Base
São José do Rio Preto, Sao Paulo, Brazil, 15090-000
Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil, 21941-913
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Sao Paulo, Brazil, 05403-000
Canada, Alberta
University of Calgary Liver Unit
Calgary, Alberta, Canada, T2N 4Z6
Bailey Health Clinic
Edmonton, Alberta, Canada, T5H 4B9
Canada, British Columbia
Liver and Intestinal Research Centre
Vancouver, British Columbia, Canada, V5Z 1H2
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
William Osler Health Centre, Brampton Memorial Hospital Campus
Brampton, Ontario, Canada, L6R 3J7
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
Canada, Quebec
Ecogene-21
Chicoutimi, Quebec, Canada, G7H 7K9
MUHC Royal Victoria Hospital
Montreal, Quebec, Canada, H4A 3J1
Chile
Hospital Universidad Católica de Chile
Santiago, Santiago Metropolitan Region, Chile, 8333-0024
Centro de Investigaciones Clínicas Viña del Mar
Viña del Mar, Valparaiso, Chile, 2540488
France
CHU de Strasbourg
Strasbourg cedex, Alsace, France, 67091
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, Aubergne, France, 63003
Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre
Caen, Basse-Normandie, France, 14000
Centre HospitalierUniversitaire de Caen - Hopital Cote de Nacre
Caen, Basse-Normandie, France, 14033
Hopital Pontchaillou
Rennes, Bretagne, France, 35033
Centre Hospitalier Regional et Universitaire de Besançon Hôpital Jean-Minjoz
Besançon cedex, Franche-Comte, France, 25030
Hôpital Jean Verdier Bondy
Bondy, Ile-De-France, France, 93143
Hôpital Beaujon
Clichy, Ile-De-France, France
Centre Hospitalier Universitaire Hopital Henri Mondor
Creteil Cedex, Ile-De-France, France, 94010
Hôpital Saint Antoine
Paris Cedex 12, Ile-de-France, France, 75571
Groupe Hospitalier - Hôpitaux Universitaires Pitie-Salpetriere - Charles-Foix - Pitie-Salpetriere
Paris Cedex 13, Ile-De-France, France, 75651
Centre Médical Odysseum
Montpellier cedex 2, Languedoc-Roussillon, France, 34960
CHU de Montpellier
Montpellier cedex 5, Languedoc-Roussillon, France, 34295
Hôpital Dupuytren
Limoges, Limousin, France, 87000
Centre hospitalier universitaire de Poitiers
Rouen, Normandie, France, 76031
Center Hospitalier Universitaire d'Angers
Angers, Pays De La Loire, France, 49000
CHU Amiens-Picardie
Amiens Cedex 1, Picardie, France, 80054
Centre Hospitalier Universitaire de Nice Hôpital l'Archet
Nice Cedex 3, Provence Alpes Cote D'Azur, France, 06202
Centre Hospitalier Universitaire Grenoble
Grenoble Cedex 09, Rhone-Alpes, France, 38043
Institut Bergonié
Bordeaux, France, 33604
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91106
Hopital Edouart Herriot
Lyon, France, 69437
Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle
Poitiers, France, 86021
Chu Rangueil
Toulouse Cedex, France, 31509
Georgia
New Hospitals Ltd
Tbilisi, Georgia, 0144
LTD Aversi Clinic
Tbilisi, Georgia, 0160
Germany
Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankhen
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Universitätsmedizin Mannheim
Mannheim, Baden-Wuerttemberg, Germany, 68167
Universitätsklinikum Tübingen
Tübingen, Baden-Wuerttemberg, Germany, 72076
Synexus Clinical Research GmbH, Prüfzentrum Frankfurt
Frankfurt, Hessen, Germany, 60313
Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
Marburg, Hessen, Germany, 35043
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Universität Bonn
Bonn, Nordhein-Westfalen, Germany, 53127
Gastroenterologische Gemeinschaftspraxis
Herne, Nordhein-Westfalen, Germany, 44623
Uniklinik RWTH Aachen
Aachen, Nordrhein-Westfalen, Germany, 52074
Uniklinik Köln
Köln, Nordrhein-westfalen, Germany, 50937
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, Rheinland-Pfalz, Germany, 55131
Gemeinschaftspraxis Drs. Denger und Pfitzner
Friedrichsthal, Saarland, Germany, 66299
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany, 66427
Universitätsklinikum Leipzig
Berlin, Germany, 04103
Praxis Driesener Strasse
Berlin, Germany, 10439
Leberzentrum am Checkpoint -Berlin
Berlin, Germany, 10969
Synexus Clinical Research GmbH, Prüfzentrum Berlin
Berlin, Germany, 12627
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 1307
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246
Gastroenterologisch-Hepatologisches Zentrum Kiel
Kiel, Germany, 24146
Greece
University Hospital of Ioannina
Ioannina, Epirus, Greece, 45500
Hippokratio Hospital
Thessaloniki, Macedoni, Greece, 54642
University General Hospital of Patras Panagia I Voithia
Patra, Peloponnese, Greece, 26504
University General Hospital of Alexandroupolis
Alexandroupoli, Thrace, Greece, 68100
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong, 00852
Prince of Wales Hospital, Dept. of Medicine and Therapeutics
Hong Kong, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
New Territories, Hong Kong
Tuen Mun Hospital
Tuen Mun, Hong Kong, 00852
Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Somogy, Hungary, 7400
SYNEXUS Magyarország Kft. - Budapest DRS
Budapest, Hungary, 1036
Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet; Szent Laszlo Korhaz
Budapest, Hungary, 1097
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft
Debrecen, Hungary, 4025
ClinTrial-UD Institute of Infectology, Clinical Pharmacology and Allergology
Debrecen, Hungary, 4031
SYNEXUS Magyarország Kft. - Gyula DRS
Gyula, Hungary, 5700
Szabolcs - Szatmár - Bereg Megyei Kórházak és Egyetemi Oktatókórház
Nyiregyhaza, Hungary, 4400
Pécsi Tudományegyetem, Klinikai Központ, I.sz.Belgyógyászati Klinika
Pécs, Hungary, 7624
Israel
Rambam Health Care Campus - Rambam Medical Center
Haifa, Israel, 3109601
Carmel Medical Center
Haifa, Israel, 3436212
The Edith Wolfson Medical Center
Holon, Israel, 5822012
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Hadassah Medical Center
Jerusalem, Israel, 91120
Galilee Medical Center
Nahariya, Israel, 22100
Ziv Medical Center-Endocrinology & Diabates Center ZIv MC
Safed, Israel, 13100
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sheba Medical Center at Tel Hashomer
Tel-Hashomer, Israel, 52621
Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy, 71013
Polo Universitario - L'Azienda Ospedaliera Luigi Sacco
Milan, Milano, Italy, 20157
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy
Azienda Ospedaliera S. Orsola - Malpighi
Bologna, Italy, 40138
Azienda Ospedaliera Universitaria Careggi
Firenze, Italy, 501 34
Ente Ospedaliero Ospedali Galliera
Genova, Italy, 16128
Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy, 20122
ASST Santi Paolo e Carlo
Milano, Italy, 20142
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano, Italy, 20162
Unità Operativa Complessa Medicina Interna a indirizzo Metabolico Nutrizionale
Modena, Italy, 41126
U.O.C. Gastroenterologia ed Epatologia Azienda Ospedaliera Universitaria Policlinico Federico II
Naples, Italy, 10126
Azienda Ospedaliero-Universitaria "Maggiore della Carità"
Novara, Italy, 28100
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Fondazione Policlinico Tor Vergata
Roma, Italy, 00133
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Policlinico Umberto I di Roma
Roma, Italy
Divisione di Gastro-Epatologia, Università di Torino Ospedale S. Giovanni Battista
Turin, Italy, 10126
Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia, LV-1002
Mexico
Consultorio Médico Dr. Alma Laura Ladron de Guevara
Mexico, Distrito Federal, Mexico, 06700
Consultorio Rosario Arechavaleta
Guadalajara, Jalisco, Mexico, 44600
JM Research - Cuernavaca
Cuernavaca, Morelos, Mexico, 62290
Investigaciones Medicas Cisneros
Monterrey, Nuevo Leon, Mexico, 64000
Consultorio Dra. Maria Sarai Gonzalez Huezo
Metepec, Mexico, 52140
Hospital Punta Sur
Queretaro, Mexico, 76090
New Zealand
Auckland City Hospital
Grafton, Auckland, New Zealand, 1148
Middlemore Clinical Trials
Papatoetoe, Auckland, New Zealand, 2025
Norway
Oslo Universitetssykehus-Ullevål Hospital
Oslo, Norway, 0424
Peru
Hospital Nacional Arzobispo Loayza
Lima, Lima 01, Peru, 15082
Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska
Wroclaw, Dolnoslaskie, Poland, 50-349
EMC Instytut Medyczny
Wroclaw, Dolnoslaskie, Poland, 54-144
VitaMED
Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-079
Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi
Lódz, Lodzkie, Poland, 91-347
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
Warszawa, Mazowieckie, Poland, 02-507
Szpital Specjalistyczny Nr 1 w Bytomiu
Bytom, Slaskie, Poland, 41-902
Specjalistyczna Praktyka Lekarska WAMED Zawiercie
Jaworze, Slaskie, Poland, 43-384
Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus
Katowice, Slaskie, Poland, 40-659
Centrum Medycyny i Stomatologii Silesia Med
Katowice, Slaskie, Poland, 40-752
ID Clinic Arkadiusz Pisula
Myslowice, Slaskie, Poland, 41-400
Portugal
Hospital Professor Doutor Fernando Fonseca
Amadora, Lisboa, Portugal, 2720-276
Hospital da Senhora da Oliveira - Guimarães
Guimaraes, Portugal, 4835-044
Centro Hospitalar Lisboa Central - Hospital Capuchos
Lisboa, Portugal, 1169-050
Centro Hospitalar de São João
Porto, Portugal, 4200-319
Hospital de São Bernardo
Setúbal, Portugal, 2910-446
Hospital Santa Luzia de Viana do Castelo
Viana do Castelo, Portugal, 4904-858
Puerto Rico
Clinical Research Puerto Rico
San Juan, Puerto Rico, 00909-1711
Fundacion de Investigacion De Diego
San Juan, Puerto Rico, 00927
Romania
Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor
Cluj-Napoca, Cluj, Romania, 400162
Centrul Medical Tuculanu SRL
Timisoara, Timis, Romania, 300158
Policlinica Dr. Citu
Timisoara, Timis, Romania, 300594
Spitalul Clinic Jude¿ean de Urgen¿a Cluj-Napoca
Cluj, Romania, 400006
Russian Federation
Clinic of Professor Gorbakov
Krasnogorsk, Moscow, Russian Federation, 143405
Infection Center
Koltsovo, Novosibirsk, Russian Federation
FSBI "Federal Siberian Scientific Clinical Center of FMBA"
Krasnoyarsk, Russian Federation, 660037
I.M. Sechenov First Moscow State Medical University
Moscow, Russian Federation, 119435
Modern Medicine Clinic
Moscow, Russian Federation, 121170
Moscow Regional Research and Clinical Institute M.F. Vladimirsky
Moscow, Russian Federation, 129110
Sklifosovsky Scientific Research Institution of Emergency Care
Moscow, Russian Federation, 196143
Novosibirsk State Regional Clinical Hospital
Novosibirsk, Russian Federation, 630087
Stavropol State Medical University
Novosibirsk, Russian Federation, 630091
Union Clinic
Saint Petersburg, Russian Federation, 191119
ECO Bezopasnost
Saint Petersburg, Russian Federation, 768828
North-Western State Medical University named after I.I. Mechnikov
Saint-Petersburg, Russian Federation, 191015
LLC "ArsVitae North-West"
Saint-Petersburg, Russian Federation, 194223
Research Institute of Influenza
Saint-Petersburg, Russian Federation, 197376
Privat Institution Educational Organization of Higher Education "Medical University "Reaviz"
Samara, Russian Federation, 443011
Smolensk City Hospital 1, Department of Infectious Diseases
Smolensk, Russian Federation, 214006
Stavropol Regional Clinical Hospital
Stavropol, Russian Federation, 355002
Stavropol Regional Clinical Hospital
Stavropol, Russian Federation, 355017
Singapore
National University Hospital
Singapore, Singapore, 119074
Singapore General Hospital
Singapore, Singapore, 169608
Slovenia
Univerzitetni klinicni center Ljubljana (University Clinical Center Ljubljana)
Ljubljana, Slovenia, 1000
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitario Donostia
San Sebastian, Guipuzcoa, Spain, 20014
Hospital General Universitario de Alicante
Alicante, Spain, 3010
Complejo Hospitalario Torrecardenas
Almeria, Spain, 4009
Hospital Santa Creu i Sant Pau
Barcelona, Spain, 00841
Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Complejo Asistencial Universitario de León
Leon, Spain, 24080
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario Ramón Y Cajal
Madrid, Spain, 28034
Hospital Puerta de Hierro Majadahonda
Majadahonda, Spain, 28222
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain, 29010
Hospital Universitario Son Espases
Palma, Spain, 7120
Complejo Hospitalario de Pontevedra
Pontevedra, Spain, 36004
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Hospital Clinico Universitario de Santiago
Santiago de Compostela, Spain, 15706
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Universitario Nuestra Senora de Valme
Sevilla, Spain, 41014
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Consorci Hospital General Universitari de València
Valencia, Spain, 46018
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50012
Switzerland
Kantonspital Sankt Gallen
St. Gallen, Saint Gallen, Switzerland, 9007
Inselspital
Bern, Switzerland, 3010
Taiwan
Changhua Christian Hospital
Changhua, Changhua City, Taiwan, 50006
Chia-Yi Christian Hospital
Chiayi City, Chiayi, Taiwan, 60002
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung, Kaohsiung City, Taiwan, 833
China Medical University Hospital
Taichung, Taichung City, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taichung City, Taiwan, 40705
National Cheng Kung University Hospital
Tainan, Tainan City, Taiwan, 70403
National Taiwan University Hospital
Taipei, Taipei City, Taiwan, 10002
Taipei Veterans General Hospital
Taipei, Taipei City, Taiwan, 11217
Tri-Service General Hospital
Taipei, Taipei City, Taiwan, 114
Cathay General Hospital
Taipei, Taiwan, 10630
Chang Gung Medical Foundation-LinKou Branch
Taoyuan, Taiwan, 33305
United Kingdom
St James's University Hospital
Leeds, West Yorkshire, United Kingdom, LS9 7TF
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, United Kingdom, GL53 7AN
Synexus North Teesside Clinical Research Centre
Hardwick, United Kingdom, TS19 8PE
Synexus Hexham Clinical Research Centre
Hexham, United Kingdom, NE46 1QJ
Hull and East Yorkshire Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ
Synexus Lancashire Clinical Research Centre
Lancashire, United Kingdom, PR7 7NARe
Synexus Merseyside Clinical Research Centre
Liverpool, United Kingdom, L22 0LG
Barts Health NHS Trust The Royal London Hospital
London, United Kingdom, E1 1BB
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Kings College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom, SW10 9NH
Luton and Dunstable Hospital NHS Foundation Trust
Luton, United Kingdom, LU4 0DZ
Synexus Manchester Clinical Research Centre
Manchester, United Kingdom, M15 6SE
University Hospital of South Manchester NHS Foundation Trust
Manchester, United Kingdom, M23 9LT
Newcastle Upon the Tyne Hospitals
Newcastle, United Kingdom, NE2 4HH
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom, NR4 7UQ
Nottingham Digestive Diseases Biomedical Research Unit
Nottingham, United Kingdom, NG7 2UH
Plymouth Hospitals NHS Trust
Plymouth, United Kingdom, PL6 8DH
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom, ST4 6QG
Swansea Bay UHB
Swansea, United Kingdom, SA2 8PP
Sponsors and Collaborators
Tobira Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Eduardo Martins Allergan
Additional Information:
Layout table for additonal information
Responsible Party: Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03028740    
Other Study ID Numbers: 3152-301-002
2016-004566-26 ( EudraCT Number )
1001 ( Registry Identifier: Registro Nacional Estudios Clinicos (RNEC) )
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Non-alcoholic Fatty Liver Disease
Fatty Liver
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
TAK-652
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents