Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
- Conditions
- Nonalcoholic Steatohepatitis
- Interventions
- Drug: SELDrug: Placebo to match SEL 6 mgDrug: Placebo to match SEL 18 mg
- Registration Number
- NCT03053050
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 808
-
Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH Clinical Research Network (CRN) classification in the opinion of the central reader
-
Has the following laboratory parameters at the screening visit:
- Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
- Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
- Hemoglobin A1c (HbA1c) ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)
- Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as Gilbert's syndrome or hemolytic anemia is present)
Key
- Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
- Child-Pugh (CP) score > 6, as determined at screening, unless due to therapeutic anti-coagulation
- Model for End-stage Liver Disease (MELD) score > 12, as determined at screening, unless due to therapeutic anti-coagulation
- Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/ or centralized review of liver histology.
- History of liver transplantation
- Current or history of hepatocellular carcinoma (HCC)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SEL 18 mg Placebo to match SEL 6 mg Randomized Phase: Selonsertib (SEL) 18 mg tablet + placebo to match SEL 6 mg tablet for 240 weeks Open-Label (OL) Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase. SEL 18 mg SEL Randomized Phase: Selonsertib (SEL) 18 mg tablet + placebo to match SEL 6 mg tablet for 240 weeks Open-Label (OL) Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase. SEL 6 mg SEL Randomized Phase: SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase. Placebo Placebo to match SEL 6 mg Randomized Phase: Placebo to match SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase. SEL 6 mg Placebo to match SEL 18 mg Randomized Phase: SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase. Placebo Placebo to match SEL 18 mg Randomized Phase: Placebo to match SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
- Primary Outcome Measures
Name Time Method Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event Week 240 EFS was assessed by the time to the first clinical event, including progression to cirrhosis on liver biopsy, liver decompensation events, liver transplantation, and all-cause mortality.
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48 Week 48 Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48 Week 48 Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).
Percentage of Participants Who Had Progression to Cirrhosis at Week 48 Week 48 Progression to cirrhosis was defined as a change in NASH CRN fibrosis stage from \< 4 at baseline to 4 at Week 48.
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240 Week 240 Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240 Week 240 Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the NAS criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.
Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48 Week 48 NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.
Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240 Week 240 NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.
Trial Locations
- Locations (290)
Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo
🇧🇷São Paulo, Brazil
Baptist Medical Center
🇺🇸Little Rock, Arkansas, United States
Southern California Liver Centers
🇺🇸Coronado, California, United States
TriWest Research Associates, LLC
🇺🇸El Cajon, California, United States
California Liver Institute
🇺🇸Pasadena, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Silicon Valley Research Institute
🇺🇸San Jose, California, United States
UF Hepatology Research at CTRB
🇺🇸Gainesville, Florida, United States
UF Health Jacksonville-Gastroenterology Emerson
🇺🇸Jacksonville, Florida, United States
Florida Research Institute
🇺🇸Lakewood Ranch, Florida, United States
Sunrise Medical Research, Inc
🇺🇸Lauderdale Lakes, Florida, United States
Advanced Research Institute
🇺🇸New Port Richey, Florida, United States
Avail Clinical Research, LLC
🇺🇸Orange City, Florida, United States
South Florida Center of Gastroenterology, PA
🇺🇸Wellington, Florida, United States
Florida Medical Clinic, PA
🇺🇸Zephyrhills, Florida, United States
Gastroenterology Associates of Hazard
🇺🇸Hazard, Kentucky, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Gastroenterology Associates of Western Michigan, P.L.C.
🇺🇸Wyoming, Michigan, United States
Huron Gastroenterology Associates/Center for Digestive Care
🇺🇸Ypsilanti, Michigan, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
University of Buffalo, Clinical and Translational Research Center
🇺🇸Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai Beth Israel
🇺🇸New York, New York, United States
University of North Carolina at Chapel Hill / UNC School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
PMG Research of Rocky Mount, LLC
🇺🇸Rocky Mount, North Carolina, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States
Northeast Clinical Research Center, LLC
🇺🇸Bethlehem, Pennsylvania, United States
Pinnacle Clinical Research, PLLC
🇺🇸Live Oak, Texas, United States
Austin Center for Clinical Research
🇺🇸Austin, Texas, United States
Baylor Scott & White All Saints Medical Center
🇺🇸Fort Worth, Texas, United States
Intermountain Liver Disease and Transplant Center
🇺🇸Murray, Utah, United States
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
🇺🇸Richmond, Virginia, United States
Verity Research, Inc.
🇺🇸Fairfax, Virginia, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Medical Campus
🇺🇸Falls Church, Virginia, United States
Emeritas Research Group
🇺🇸Lansdowne Town Center, Virginia, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
St. Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Instituto Oulton
🇦🇷Córdoba, Argentina
St. George's Hospital
🇦🇺Kogarah, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Hospital das Clínicas da Faculdade de Medicina de Botucatu - FMB/Universidade Estadual Paulista Julio de Mesquita Filho - UNESP
🇧🇷Botucatu, Brazil
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
🇧🇷Porto Alegre, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
🇧🇷Ribeirão Preto, Brazil
Universidade Federal de São Paulo / Unidade Ambulatorial de Pesquisa Clínica - I (UAPC-I)
🇧🇷São Paulo, Brazil
University of Calgary Liver Unit (Heritage Medical Research Clinic)
🇨🇦Calgary, Alberta, Canada
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)
🇨🇦Edmonton, Alberta, Canada
LAIR Centre
🇨🇦Vancouver, British Columbia, Canada
Gordon and Leslie Diamond Health Care Centre
🇨🇦Vancouver, British Columbia, Canada
South Shore Medical Arts
🇨🇦London, Ontario, Canada
Centre Hospitalier Universitaire Estaing
🇫🇷Clermont-Ferrand, France
Centre Hospitalier Universitaire d'Angers
🇫🇷Angers, France
Hopital Henri Mondor
🇫🇷Créteil, France
CHU de Grenoble- Hopital Michallon
🇫🇷Grenoble, France
CHU de Limoges- Hopital Dupuytren- Federation Hepatologie
🇫🇷Limoges, France
Centre Hospitalier Regional Universitaire- Hopital Claude Huriez
🇫🇷Lille, France
Hopital de la Croix Rousse
🇫🇷Lyon, France
Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2
🇫🇷Nice, France
Hôpital Saint Joseph
🇫🇷Marseille, France
Hopital Beaujon
🇫🇷Pessac, France
Hopital Cochin
🇫🇷Paris, France
Centre Hospitalier Universitaire de Bordeaux
🇫🇷Pessac, France
Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil
🇫🇷Strasbourg, France
Centre Hospitalier Universitaire de Toulouse- Hopital Purpan
🇫🇷Toulouse, France
Uniklinik RWTH Aachen, Medizinische Klinik III
🇩🇪Aachen, Germany
Medizinische Hochschule Hannover
🇩🇪Hanover, Germany
Hopital Paul Brousse
🇫🇷Villejuif, France
Universitatsklinikum Frankfurt der Goethe-Universitat
🇩🇪Frankfurt, Germany
Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp)
🇩🇪Berlin, Germany
Universitatsklinikum Bonn (AoR)
🇩🇪Bonn, Germany
Uniklinikum des Saarlandes- Klinik fur Innere Medizin II
🇩🇪Homburg, Germany
Gastroenterologisch- Hepatologisches Zentrum Kiel
🇩🇪Kiel, Germany
Johannes Gutenberg-Universitat
🇩🇪Mainz, Germany
Eugastro Gmbh
🇩🇪Leipzig, Germany
Tuen Mun Hospital
🇭🇰Tuen Mun, Hong Kong
Midas Multispecialty Hospital
🇮🇳Nagpur, Maharashtra, India
Institute of Post Graduate Medical Education and Research / SSKM Hospital
🇮🇳Kolkata, India
Kasturba Medical College (KMC) Hospital
🇮🇳Mangalore, India
Global Hospital-Super Speciality & Transplant Centre (A Unit of Centre for Digestive and Kidney Diseases (India) Pvt. Ltd.)
🇮🇳Mumbai, India
Maharaja Agrasen Hospital
🇮🇳New Delhi, India
All India Institute of Medical Sciences
🇮🇳New Delhi, India
Fortis Flt. Lt. Rajan Dhall Hospital
🇮🇳New Delhi, India
Institute of Liver & Biliary Sciences
🇮🇳New Delhi, India
The Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
Holy Family hospital
🇮🇱Nazaret, Israel
The Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
Azienda Ospedaliera Universitaria Pisana
🇮🇹Pisa, Italy
IRCCS Ospedale Casa Sollievo Della Soferrenza
🇮🇹San Giovanni Rotondo, Italy
Chiba University Hospital
🇯🇵Chiba, Japan
Fukui-Ken Saiseikai Hospital
🇯🇵Fukui-shi, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
🇯🇵Hiroshima, Japan
Juntendo University Shizuoka Hospital
🇯🇵Izunokuni, Japan
Toranomon Hospital Kajigaya
🇯🇵Kawasaki, Japan
Shinkokura Hospital
🇯🇵Kitakyushu, Japan
Kumamoto Shinto General Hospital
🇯🇵Kumamoto, Japan
University Hospital, Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Shinshu University Hospital
🇯🇵Matsumoto, Japan
Japanese Red Cross Musashino Hospital
🇯🇵Musashino, Japan
Miyazaki Medical Center Hospital
🇯🇵Miyazaki, Japan
Aichi Medical University Hospital
🇯🇵Nagakute, Japan
Heart Life Hospital
🇯🇵Nakagami, Japan
Hyogo College of Medicine Hospital
🇯🇵Nishinomiya, Japan
Nara City Hospital
🇯🇵Nara, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
Kawasaki Medical School General Medical Center
🇯🇵Okayama, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Saga University Hospital
🇯🇵Saga, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
🇯🇵Sapporo, Japan
Tohoku Rosai Hospital
🇯🇵Sendai, Japan
National Center for Global Health and Medicine Hospital
🇯🇵Shinjuku-ku, Japan
Saiseikai Suita Hospital
🇯🇵Suita, Japan
Mie University Hospital
🇯🇵Tsu, Japan
Ehime University Hospital
🇯🇵Tōno, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Japan
National Hospital Organization Nagasaki Medical Center
🇯🇵Ōmura, Japan
Hirakata Kohsai Hospital
🇯🇵Ōsaka, Japan
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
National Health Insurance Service- Ilsan Hospital
🇰🇷Goyang-si, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
🇰🇷Wŏnju, Korea, Republic of
Hospital Selayang
🇲🇾Batu Caves, Malaysia
University of Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
Phylasis Clinicas Research S. de RL de CV.
🇲🇽Cuautitlán, Mexico
Consultorio Médico
🇲🇽Mexico City, Mexico
Investigaciones Medicas Cisneros SC
🇲🇽Monterrey, Mexico
Auckland City Hospital
🇳🇿Grafton, New Zealand
Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii
🇵🇱Bytom, Poland
Centro Hospitalar de Tras-os-Montes e Alto Douro, E.P.E
🇵🇹Vila Real, Portugal
Klinical Investigations Group, LLC
🇵🇷San Juan, Puerto Rico
VA Caribbean Healthcare System
🇵🇷San Juan, Puerto Rico
Fundacion de Investigacion de Diego
🇵🇷San Juan, Puerto Rico
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore
Changi General Hospital Pte Ltd.
🇸🇬Singapore, Singapore
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Puerto de Hierro Majadahonda
🇪🇸Majadahonda, Spain
CHOP_Complejo Hospitalrio Universitario de Pontevedra
🇪🇸Pontevedra, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Changhua Christian Hospital
🇨🇳Chang-hua, Taiwan
Ditmanson Medical Foundation Chia-Yi Christian Hospital
🇨🇳Chiayi City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
E-DA Hospital
🇨🇳Kaohsiung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Mackay Memorial Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital
🇨🇳Keelung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospitalv
🇨🇳Tainan, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Edgbaston, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Derby Teaching Hospitals NHS FT
🇬🇧Derby, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle upon Tyne, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
🇬🇧Norwich, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Abertawe Bro Morgannwg University Health Board
🇬🇧Swansea, United Kingdom
Institute of Liver Health
🇺🇸Chandler, Arizona, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Digestive Disease Associates, PA
🇺🇸Catonsville, Maryland, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Delta Research Partners, LLC
🇺🇸Bastrop, Louisiana, United States
Ocshner Medical Center
🇺🇸New Orleans, Louisiana, United States
Greenville Health System - Gastroenterology and Liver Center
🇺🇸Greenville, South Carolina, United States
Gastro One
🇺🇸Germantown, Tennessee, United States
CUB Hopital Erasme
🇧🇪Brussels, Belgium
Rambam Health Care Campus
🇮🇱Haifa, Israel
Kagawa Prefectural Central Hospital
🇯🇵Takamatsu, Japan
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Monash Health, Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
(G.I.R.I.) GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin
🇦🇹Graz, Austria
St. Vincent's Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
UZ Brussel
🇧🇪Brussel, Belgium
Allgemeines Krankenhaus Wien
🇦🇹Vienna, Austria
Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)
🇨🇦Montréal, Quebec, Canada
Kagoshima University Medical And Dental Hospital
🇯🇵Kagoshima, Japan
Kurume University Hospital
🇯🇵Kurume, Japan
Yamagata University Hospital
🇯🇵Yamagata, Japan
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
The Alfred Hospital, Alfred Health
🇦🇺Melbourne, Victoria, Australia
Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Belgium
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Tokyo Medical University Ibaraki Medical Center
🇯🇵Ibaraki, Japan
Kanazawa University Hospital
🇯🇵Kanagawa, Japan
Nara Medical University Hospital
🇯🇵Kashihara, Japan
Toranomon Hospital
🇯🇵Minato, Japan
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
🇵🇱Łódź, Poland
National University Hospital
🇸🇬Singapore, Singapore
Singapore General Hospital
🇸🇬Singapore, Singapore
Khoo Teck Puat Hospital
🇸🇬Singapore, Singapore
Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie
🇨🇭Bern, Switzerland
Istituto Cantonale di Patologia Locarno
🇨🇭Lugano, Switzerland
Cathay General Hospital
🇨🇳Taipei, Taiwan
Portsmouth Hospitals NHS Trust
🇬🇧Portsmouth, United Kingdom
eStudySite
🇺🇸Pittsburgh, Pennsylvania, United States
United Gastroenterologists
🇺🇸Costa Mesa, California, United States
Fresno Clinical Research Center
🇺🇸Fresno, California, United States
Ruane Clinical Research Group
🇺🇸Los Angeles, California, United States
Integrity Clinical Research, LLC
🇺🇸Doral, Florida, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Digestive Healthcare of Georgia
🇺🇸Atlanta, Georgia, United States
Piedmont Transplant Institute
🇺🇸Atlanta, Georgia, United States
Gastrointestinal Specialists of Georgia, PC
🇺🇸Marietta, Georgia, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Northwell Health - Sandra Atlas Bass Center for Liver Diseases
🇺🇸Manhasset, New York, United States
Northwestern Memorial Hospital; Clinical Research Unit
🇺🇸Chicago, Illinois, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Southern Therapy and Advanced Research LLC (STAR)
🇺🇸Ridgeland, Mississippi, United States
Rutgers New Jersey Medical School- Doctors Office Center
🇺🇸Newark, New Jersey, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
NorthShore University Healthsystem
🇺🇸Glenview, Illinois, United States
Meritus Center for Clinical Research
🇺🇸Hagerstown, Maryland, United States
Triad Clinical Trials LLC
🇺🇸Greensboro, North Carolina, United States
Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
🇺🇸Statesville, North Carolina, United States
Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
🇺🇸Pittsburgh, Pennsylvania, United States
VA Pittsburgh Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States
Guthrie Medical Group, PC
🇺🇸Sayre, Pennsylvania, United States
WR-ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Texas Clinical Research Institute, LLC
🇺🇸Arlington, Texas, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
Texas Digestive Disease Consultants
🇺🇸Dallas, Texas, United States
The University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Royal Brisbane & Women's Hospital
🇦🇺Herston, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
PerCuro Clinical Research Ltd.
🇨🇦Victoria, British Columbia, Canada
Toronto Center for Liver Diseases (TCLD), Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Sunrise Research Institute
🇺🇸Miami, Florida, United States
Schiff Center for Liver Diseases/University of Miami
🇺🇸Miami, Florida, United States
Genoma Research Group, Inc
🇺🇸Miami, Florida, United States
Indiana University Health - University Hospital
🇺🇸Indianapolis, Indiana, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
Kelsey-Seybold Clinic
🇺🇸Houston, Texas, United States
Baylor College of Medicine - Advanced Liver Therapies
🇺🇸Houston, Texas, United States
Swedish Organ Transplant and Liver Center
🇺🇸Seattle, Washington, United States
VAMC & Baylor College
🇺🇸Houston, Texas, United States
Virginia Mason
🇺🇸Seattle, Washington, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Kaiser Permanente
🇺🇸San Diego, California, United States
California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant
🇺🇸San Francisco, California, United States
Mission Gastroenterology and Hepatology
🇺🇸San Francisco, California, United States
University of California San Francisco (UCSF)
🇺🇸San Francisco, California, United States
University of Minnesota Medical Center - Fairview
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center - Duke South Clinics
🇺🇸Durham, North Carolina, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
UC Health/Holmes Hospital
🇺🇸Cincinnati, Ohio, United States
Quality Medical Research PLLC
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center - Digestive Disease Center
🇺🇸Nashville, Tennessee, United States
American Research Corporation, The Texas Liver Institute
🇺🇸San Antonio, Texas, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Banner University Medical Center-Phoenix
🇺🇸Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
William Osler Health System-Brampton Civic Hospital
🇨🇦Brampton, Ontario, Canada
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Digestive Health Specialists, PA
🇺🇸Winston-Salem, North Carolina, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Kansas City Gastroenterology and Hepatology
🇺🇸Kansas City, Missouri, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Froedtert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States
University of California San Diego (UCSD)
🇺🇸La Jolla, California, United States
University Gastroenterology
🇺🇸Providence, Rhode Island, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands
Alice Ho Miu Ling Nethersole Hospital
🇭🇰Tai Po, Hong Kong