Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
- Conditions
- Compensated CirrhosisNonalcoholic Steatohepatitis
- Interventions
- Drug: Obeticholic acid (10 mg)Drug: Obeticholic acid (10 mg to 25 mg)Drug: Placebo
- Registration Number
- NCT03439254
- Lead Sponsor
- Intercept Pharmaceuticals
- Brief Summary
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 919
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obeticholic Acid (OCA) 10 mg Obeticholic acid (10 mg) 10 mg OCA for up to 18 months Obeticholic Acid (OCA) 10 mg to 25 mg Obeticholic acid (10 mg to 25 mg) 10 mg OCA for the first 3 months and then may titrate up to 25 mg OCA for the remaining 15 months of the study Placebo Placebo Placebo for up to 18 months
- Primary Outcome Measures
Name Time Method DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH) Up to 18 months Fibrosis stage was evaluated by NASH Clinical Research Network(CRN)Fibrosis Staging System with stages:0=no fibrosis;1=perisinusoidal/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 semiquantitative scoring system based on unweighted sum of:steatosis (0=\<5% to 3=\>66%),lobular inflammation(0=no foci to 3=\>4 foci/200x),hepatocellular ballooning(0=none to 2=many cells/prominent ballooning)scores.Total scale range:0-12;0:no features of fatty liver disease and 12:highest degree of fatty liver disease.Higher scores:worse symptoms.Responders:did not discontinue treatment due to Adverse event(AE) or did not die and had evaluable post-Baseline biopsy assessment
OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to 12 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
OLE Phase: Change From Baseline to Month 12 in Liver Stiffness Measurement (LSM) Baseline and up to Month 12 Non-invasive radiological methods to assess liver stiffness were conducted at selected study sites where the respective devices were available. These assessments were taken by vibration controlled transient elastography (TE) method using FibroScan®. Participant was included as a random effect and an unstructured covariance matrix was used assuming convergence could be attained. Baseline was defined as the last value collected prior to the first administration of the investigational product (IP). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
OLE Phase: Fibrosis-4 (FIB-4) at Baseline Baseline (Day 1) FIB-4 was a noninvasive assessment of liver disease assessed by a combination of age, alanine aminotransferase (ALT) and platelet results. FIB-4 was the ratio of age in years and aminotransferase to platelet count. It was a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, ALT, Aspartate aminotransferase (AST) and age that was calculated using formula: FIB-4 = (Age \[years\] x AST \[Units per Liter {U/L}\]) / (platelets \[10\^9/L\] x (square root of ALT \[U/L\])). A FIB-4 index of \<1.45 indicated no or moderate fibrosis and an index of \> 3.25 indicated extensive fibrosis/cirrhosis. Higher ratio indicated worse condition. Baseline was defined as the last value collected prior to the first administration of the IP.
OLE Phase: Enhanced Liver Fibrosis (ELF) at Baseline Baseline (Day 1) ELF was non-invasive panel of circulating fibrosis markers calculated from serum biomarkers. The markers of fibrosis comprised hyaluronic acid (HA), tissue inhibitor of metalloproteinase (TIMP1) and procollagen III N-terminal peptide (PIIINP). Each of these markers was measured by an immunoassay and an ELF score was generated, from which a level of fibrosis severity could be determined. The ELF test was a composite score: \< 7.7: no to mild fibrosis; ≥ 7.7 - \< 9.8: Moderate fibrosis; ≥ 9.8 - \< 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.; higher ELF scores were associated with worsening liver fibrosis. Baseline was defined as the last value collected prior to the first administration of the IP.
OLE Phase: Number of Participants Reporting All-cause Mortality Up to Month 12 All-cause mortality is defined as death due to any cause. Number of participants reporting all-cause mortality is presented
OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Ascites, Hepatocellular Carcinoma (HCC) and Non-liver Related Death Up to 12 months Adjudication was performed under the review of Hepatic Safety Adjudication Committee (HSAC) of all available data for each identified participant to determine liver injury status. Number of participants with adjudicated liver related clinical outcomes for the following is presented: Ascites (secondary to cirrhosis and requiring medical intervention), Hepatocellular carcinoma (HCC) and non-liver related death.
OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Worsening of Child-Pugh Score Up to 12 months The Child-Pugh classification was a scoring system used for the classification of the severity of cirrhosis. It included three continuous variables (bilirubin, albumin, and international normalized ratio) and two discrete variables (ascites and encephalopathy). Each variable was scored 1-3 with 3 indicating most severe derangement. The determination of Child-Pugh score ranged from 5 to 15. The higher the score, the sicker the participant. Adjudication was performed under the review of HSAC of all available data for each identified participant to determine liver injury status. Number of participants with adjudicated liver related clinical outcomes for worsening of Child-Pugh score is presented.
OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Model for End-Stage Liver Disease (MELD) Score ≥15 Up to 12 months MELD was a scoring system for assessing the severity of chronic liver disease and to assess prognosis and suitability for liver transplantation. It 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. Higher scores indicated greater disease severity. Adjudication was performed under the review of HSAC of all available data for each identified participant to determine liver injury status. Number of participants with adjudicated liver related clinical outcomes for MELD score ≥15 is presented.
- Secondary Outcome Measures
Name Time Method DB Phase: Change From Baseline to Month 18 in LSM Baseline and up to Month 18 Non-invasive radiological methods to assess liver stiffness were conducted at selected study sites where the respective devices were available. These assessments were taken by vibration controlled TE method using FibroScan®. Participant was included as a random effect and an unstructured covariance matrix was used assuming convergence could be attained. The principal comparison was at Month 18. Baseline was defined as the last value collected prior to the first administration of the IP. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
DB Phase: ELF at Baseline Baseline (Day 1) ELF was non-invasive panel of circulating fibrosis markers calculated from serum biomarkers. The markers of fibrosis comprised HA, TIMP1 and PIIINP. Each of these markers was measured by an immunoassay and an ELF score was generated, from which a level of fibrosis severity could be determined. The ELF test was a composite score: \< 7.7: no to mild fibrosis; ≥ 7.7 - \< 9.8: Moderate fibrosis; ≥ 9.8 - \< 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis.; higher ELF scores were associated with worsening liver fibrosis. Baseline was defined as the last value collected prior to the first administration of the IP.
DB Phase: FIB-4 at Baseline Baseline (Day 1) FIB-4 was a noninvasive assessment of liver disease assessed by a combination of age, ALT and platelet results. FIB-4 was the ratio of age in years and aminotransferase to platelet count. It was a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, ALT, AST and age that was calculated using formula: FIB-4 = (Age \[years\] x AST \[U/L\]) / (platelets \[10\^9/L\] x (square root of ALT \[U/L\])). A FIB-4 index of \<1.45 indicated no or moderate fibrosis and an index of \> 3.25 indicated extensive fibrosis/cirrhosis. Higher ratio indicated worse condition. Baseline was defined as the last value collected prior to the first administration of the IP.
Trial Locations
- Locations (189)
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Sierra Clinical Research
🇺🇸Las Vegas, Nevada, United States
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
Cedars-Sinani Medical Center
🇺🇸Los Angeles, California, United States
Hi Tech and Global Research LLC
🇺🇸Coral Gables, Florida, United States
eStudySite
🇺🇸La Mesa, California, United States
University of California, San Francisco-Fresno
🇺🇸Fresno, California, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Innovative Medical Research of South Florida, Inc.
🇺🇸Aventura, Florida, United States
University at Buffalo, Clinical and Translational Research Center
🇺🇸Buffalo, New York, United States
Louisiana Research Center
🇺🇸Shreveport, Louisiana, United States
Florida Medical Clinic, P.A
🇺🇸Zephyrhills, Florida, United States
UMass Memorial Health Care
🇺🇸Worcester, Massachusetts, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Schiff Center for Liver Diseases/University of Miami
🇺🇸Miami, Florida, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
South Denver Gastroenterology, PC
🇺🇸Englewood, Colorado, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
UF Health Jacksonville-Gastroenterology Emerson
🇺🇸Jacksonville, Florida, United States
Delta Research Partners, LLC
🇺🇸Monroe, Louisiana, United States
Carolinas Center for Liver Disease/Carolinas HealthCare System
🇺🇸Huntersville, North Carolina, United States
Diabetes & Endocrinology Consultants, PC
🇺🇸Morehead City, North Carolina, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
🇺🇸Wyoming, Michigan, United States
The Emory Clinic (TEC)
🇺🇸Atlanta, Georgia, United States
Grand Teton Research Group, PLLC
🇺🇸Idaho Falls, Idaho, United States
Southern Therapy and Advanced Research (STAR) LLC
🇺🇸Jackson, Mississippi, United States
Ichan School of Medicine at Mount Sinai Beth Israel
🇺🇸New York, New York, United States
Huron Gastroenterology Associates
🇺🇸Ypsilanti, Michigan, United States
Asheville Gastroenterology Associates, P.A.
🇺🇸Asheville, North Carolina, United States
Charité - Universitätsmedzin Berlin
🇩🇪Berlin, Germany
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
The University of Texas Medical School at Houston
🇺🇸Houston, Texas, United States
Charlotte Gastroenterology & Hepatology, PLLC
🇺🇸Charlotte, North Carolina, United States
Trial Management Associates, LLC
🇺🇸Wilmington, North Carolina, United States
Associates in Gastroenterology, PLC
🇺🇸Hermitage, Tennessee, United States
CHU Amiens Picardie
🇫🇷Amiens, France
Liver Center of Texas
🇺🇸Dallas, Texas, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
Gastroenterology Consultants of Southwest Virginia
🇺🇸Roanoke, Virginia, United States
Mater Misericordiae Limited
🇦🇺South Brisbane, Queensland, Australia
Hôpital Beaujon- Service d'Hepatologie
🇫🇷Clichy, France
Virginia Mason - Seattle Medical Center
🇺🇸Seattle, Washington, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
The Pennsylvania State University and the Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Baylor College of Medicine - Advanced Liver Therapies
🇺🇸Houston, Texas, United States
University of Calgary Liver Unit (Heritage Medical Research Clinic)
🇨🇦Calgary, Alberta, Canada
Centex Studies, Inc.
🇺🇸McAllen, Texas, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Baylor Scott and White All Saints Medical Center
🇺🇸Fort Worth, Texas, United States
Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Kent Place
🇨🇦Lindsay, Ontario, Canada
Chronic Viral Illness/McGill University Health Centre (MUHC)
🇨🇦Montreal, Quebec, Canada
Texas Digestive Disease Consultants
🇺🇸San Marcos, Texas, United States
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Nepean Blue Mountains Local Health District, Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
London Health Sciences Centre-University Hospital
🇨🇦London, Ontario, Canada
The University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads
🇺🇸Newport News, Virginia, United States
Universitätsmedizin Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany
Synexus Polska Sp. z o.o., Oddział w Częstochowie
🇵🇱Częstochowa, Poland
Fundación de Investigación de Diego
🇵🇷San Juan, Puerto Rico
Univeritätsklinkum Würzburg
🇩🇪Würzburg, Bayern, Germany
Center Hospitalier Universitaire Grenoble Alpes
🇫🇷La Tronche, France
Teuber Consulting & Research UG
🇩🇪Frankfurt am main, Hessen, Germany
Kyiv Railway Clinical Hospital №2 of branch "Health Center" of the Joint-Stock Company "Ukranian Railway", Day treatment department
🇺🇦Kyiv, Ukraine
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
CHRU de Nancy - Hôpitaux de Brabois
🇫🇷Vandoeuvre-les-Nancy, France
Hospital Universitari i Politécnic La Fe
🇪🇸Valencia, Spain
Hôpital de la Croix Rousse
🇫🇷Lyon Cedex 04, France
Hôpital Paul Brousse
🇫🇷Villejuif, France
Universitätsklinikum Leipzig AöR
🇩🇪Leipzig, Sachsen, Germany
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hôpital Purpan
🇫🇷Toulouse, France
EUGASTRO GmbH
🇩🇪Leipzig, Sachsen, Germany
CHU de Rouen-Centre Hospitalier Universitaire
🇫🇷Rouen, France
Middlemore Hospital
🇳🇿Auckland, New Zealand
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Madrid, Spain
Kansas Medical Clinic
🇺🇸Topeka, Kansas, United States
Gastroenterologisch-Hepatologisches Zentrum Kiel
🇩🇪Kiel, Schleswig-Holstein, Germany
University of California, San Francisco
🇺🇸San Francisco, California, United States
Quaility Medical Research, PLLC
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center - Digestive Disease Center
🇺🇸Nashville, Tennessee, United States
American Research Corporation
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, England, United Kingdom
Synexus Polska Sp. Z.o.o., Oddział w Gdyni
🇵🇱Gdynia, Poland
Synexus Polska Sp. z o.o., Oddział w Wrocławiu
🇵🇱Wrocław, Poland
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, England, United Kingdom
NYU Langone Health
🇺🇸New York, New York, United States
Synexus Magyarország Kft. Budapest
🇭🇺Budapest, Hungary
Synexus Polska Sp. z.o.o., Oddział w Gdańsku
🇵🇱Gdańsk, Poland
Synexus Polska Sp. z o.o., Oddział w Łodzi
🇵🇱Łódź, Poland
Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, Oxfordshire, United Kingdom
Synexus Polska Sp. z o.o., Oddział w Katowicach
🇵🇱Katowice, Poland
Synexus Polska Sp. z o.o., Oddział w Warszawie
🇵🇱Warszawa, Poland
Royal Free Hospital NHS Foundation Trust
🇬🇧London, England, United Kingdom
Derby Teaching Hospitals NHS Foundation Trust
🇬🇧Derby, Derbyshire, United Kingdom
Imperial College Healthcare NHS Trust, St Mary's Hospital
🇬🇧London, England, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, England, United Kingdom
CHU de Nice, Hôpital de l'Archet 2
🇫🇷Nice, France
Centre Hospitalier Universitaire d'Angers
🇫🇷Angers, France
Toronto Liver Centre
🇨🇦Toronto, Ontario, Canada
Office of Dr. Gauthier
🇨🇦North Bay, Ontario, Canada
CHI Health Alegent Creighton Clinic
🇺🇸Omaha, Nebraska, United States
St Vincent's Hospital
🇦🇺Fitzroy, Victoria, Australia
University of Colorado Denver and Hospital
🇺🇸Aurora, Colorado, United States
Guardian Angel Research Center, INC
🇺🇸Tampa, Florida, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
Amici GI-LLC
🇺🇸Martinsville, New Jersey, United States
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Liver Wellness Center
🇺🇸Little Rock, Arkansas, United States
Arizona Liver Health
🇺🇸Glendale, Arizona, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Objective GI d/b/a North Alabama GI Research Center
🇺🇸Madison, Alabama, United States
The Institute for Liver Health
🇺🇸Tucson, Arizona, United States
Scripps Whittier Diabetes Institute
🇺🇸La Jolla, California, United States
Palmtree Clinical Research, INC.
🇺🇸Palm Springs, California, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
Gastroenterology Associates of Pensacola, PA
🇺🇸Pensacola, Florida, United States
Sensible Healthcare, LLC
🇺🇸Ocoee, Florida, United States
Innovation Medical Research Center
🇺🇸Palmetto Bay, Florida, United States
Tampa General Medical Group
🇺🇸Tampa, Florida, United States
Summit Clinical Research, LLC
🇺🇸Athens, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Aquiant Research
🇺🇸New Albany, Indiana, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Lahey Hospital & Medical Center
🇺🇸Burlington, Massachusetts, United States
Minnesota Gastroenterology, P.A.
🇺🇸Saint Paul, Minnesota, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Dayton Gastroenterology, Inc.
🇺🇸Beavercreek, Ohio, United States
Northeast Clinical Research Center, LLC
🇺🇸Bethlehem, Pennsylvania, United States
Carolinas Health Care System Center for Liver Disease
🇺🇸Huntersville, North Carolina, United States
UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Einstein Healthcare Network
🇺🇸Philadelphia, Pennsylvania, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Methodist Healthcare University Hospital
🇺🇸Memphis, Tennessee, United States
Johnson City Medical Center
🇺🇸Johnson City, Tennessee, United States
Texas Clinical Research Institute LLC
🇺🇸Arlington, Texas, United States
Rapid City Medical Center LLP
🇺🇸Rapid City, South Dakota, United States
San Antonio Military Medical Center
🇺🇸Fort Sam Houston, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
(G.I.R.I.) GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
Clinique de medecine Urbaine du Quartier Latin
🇨🇦Montréal, Quebec, Canada
Centre Hospitalier Universitaire de Strasbourg
🇫🇷Strasbourg, France
Hôpital Pitié-Salpêtrierè
🇫🇷Paris, France
Hôpital Hautepierre
🇫🇷Strasbourg, France
Universitätsklinikum Hamburg Eppendorf
🇩🇪Hamburg, Germany
Synexus Magyarorszag Kft. Debrecen A.S.
🇭🇺Debrecen, Hungary
Synexus Magyarorszag Kft. Gyula DRS
🇭🇺Gyula, Hungary
Dunedin Public Hospital
🇳🇿Dunedin, New Zealand
Wellington Regional Hospital
🇳🇿Wellington, New Zealand
Synexus Polska Sp. z o.o., Oddział w Poznaniu
🇵🇱Poznań, Poland
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department
🇺🇦Kyiv, Ukraine
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
Tandem Clinical Research, LLC
🇺🇸Marrero, Louisiana, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Kaiser Permanente Sacramento Medical Center
🇺🇸Sacramento, California, United States
University of Louisville, Clinical Trials Unit
🇺🇸Louisville, Kentucky, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Kansas City Research Institute
🇺🇸Kansas City, Missouri, United States
University of North Carolina at Chapel Hill, School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
Ralph H. Johnson Veterans Affairs Medical Center
🇺🇸Charleston, South Carolina, United States
SCTR Research Nexus
🇺🇸Charleston, South Carolina, United States
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours
🇺🇸Richmond, Virginia, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States