MedPath

Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

Phase 3
Terminated
Conditions
Nonalcoholic Steatohepatitis
Interventions
Drug: SEL
Drug: Placebo to match SEL 18 mg
Drug: Placebo to match SEL 6 mg
Registration Number
NCT03053063
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 associated complications in adults with cirrhosis due to NASH.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
883
Inclusion Criteria
  • Liver biopsy consistent with NASH and cirrhosis (F4 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, as determined by the central laboratory:

    • 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
    • HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 micromole (μmol) if HbA1c is unable to be resulted)
    • International normalised ratio (INR) ≤ 1.4, unless due to therapeutic anti-coagulation
    • Platelet count ≥ 100,000/μL

Key

Exclusion Criteria
  • Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
  • Child-Pugh (CP) score > 7, 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-antitrypsin 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
GroupInterventionDescription
SEL 6 mgSELRandomized Phase: SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks. Open-Label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
SEL 6 mgPlacebo to match SEL 18 mgRandomized Phase: SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks. Open-Label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
SEL 18 mgPlacebo to match SEL 6 mgRandomized Phase: SEL 18 mg plus placebo to match SEL 6 mg for up to 240 weeks. Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
PlaceboPlacebo to match SEL 18 mgRandomized Phase: Placebo to match SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks. Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
SEL 18 mgSELRandomized Phase: SEL 18 mg plus placebo to match SEL 6 mg for up to 240 weeks. Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
PlaceboPlacebo to match SEL 6 mgRandomized Phase: Placebo to match SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks. Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASHWeek 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.

Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical EventWeek 240

EFS was assessed by the time to the first clinical event, including liver decompensation events, liver transplantation and all-cause mortality.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants Who Had NASH Resolution at Week 48Week 48

NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning reduced to 0 from a value ≥ 1 at baseline; both criteria were necessary conditions. 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. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1.

Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240Week 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 240Week 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 at Week 240Week 240

NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning reduced to 0 from a value ≥ 1 at baseline; both criteria were necessary conditions.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. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1.

Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48Week 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).

Trial Locations

Locations (281)

Ruane Clinical Research Group

🇺🇸

Los Angeles, California, United States

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

🇺🇸

Boston, Massachusetts, United States

Southern Therapy and Advanced Research LLC (STAR)

🇺🇸

Ridgeland, Mississippi, United States

Thomas Jefferson University Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute

🇺🇸

Pittsburgh, Pennsylvania, United States

Royal Brisbane & Women's Hospital

🇦🇺

Herston, Queensland, Australia

Toronto Liver Centre

🇨🇦

Toronto, Ontario, Canada

Baylor College of Medicine - Advanced Liver Therapies

🇺🇸

Houston, Texas, United States

Swedish Organ Transplant and Liver Center

🇺🇸

Seattle, Washington, United States

Indiana University Health - University Hospital

🇺🇸

Indianapolis, Indiana, United States

Fresno Clinical Research Center

🇺🇸

Fresno, California, United States

Southern California Research Center

🇺🇸

Coronado, California, United States

Scripps Clinical Research Services

🇺🇸

La Jolla, California, United States

University of California, San Diego (Altman Clinical and Translational Research Center)

🇺🇸

La Jolla, California, United States

Cedars-Sinai Medical Center

🇺🇸

Los Angeles, California, United States

Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center

🇺🇸

Los Angeles, California, United States

California Liver Research Institute

🇺🇸

Pasadena, California, United States

Inland Empire Liver Foundation

🇺🇸

Rialto, California, United States

Island View Gastroenterology Associates- Ventura

🇺🇸

Ventura, California, United States

IMIC Inc

🇺🇸

Palmetto, Florida, United States

Clinical Research of Homestead

🇺🇸

Homestead, Florida, United States

Schiff Center for Liver Diseases/University of Miami

🇺🇸

Miami, Florida, United States

South Florida Center of Gastroenterology, PA

🇺🇸

Wellington, Florida, United States

Cleveland Clinic Florida

🇺🇸

Weston, Florida, United States

Digestive Healthcare of Georgia

🇺🇸

Atlanta, Georgia, United States

Florida Medical Clinic, PA

🇺🇸

Zephyrhills, Florida, United States

Piedmont Transplant Institute

🇺🇸

Atlanta, Georgia, United States

Columbus Regional Research Institute

🇺🇸

Columbus, Georgia, United States

Gastroenterology Associates of Central Georgia, LLC

🇺🇸

Macon, Georgia, United States

Gastrointestinal Specialists of Georgia, PC

🇺🇸

Marietta, Georgia, United States

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

Indianapolis Gastroenterology Research Foundation

🇺🇸

Indianapolis, Indiana, United States

The University of Chicago Medical Center

🇺🇸

Chicago, Illinois, United States

Northwestern Memorial Hospital; Clinical Research Unit

🇺🇸

Chicago, Illinois, United States

NorthShore University HealthSystem - Glenbrook ACC

🇺🇸

Glenview, Illinois, United States

Gastroenterology Associates of Hazard

🇺🇸

Hazard, Kentucky, United States

Delta Research Partners

🇺🇸

Bastrop, Louisiana, United States

Ocshner Medical Center

🇺🇸

New Orleans, Louisiana, United States

Louisiana Research Center, LLC

🇺🇸

Shreveport, Louisiana, United States

Mercy Medical Center

🇺🇸

Baltimore, Maryland, United States

Meritus Center for Clinical Research

🇺🇸

Hagerstown, Maryland, United States

Digestive Disease Associates, PA

🇺🇸

Catonsville, Maryland, United States

Saint Luke's Hospital of Kansas City

🇺🇸

Kansas City, Missouri, United States

Kansas City Research Institute

🇺🇸

Kansas City, Missouri, United States

Saint Louis University

🇺🇸

Saint Louis, Missouri, United States

AccumetRx Clinical Research

🇺🇸

Albuquerque, New Mexico, United States

University of Buffalo, Clinical and Translational Research Center

🇺🇸

Buffalo, New York, United States

Northwell Health - Sandra Atlas Bass Center for Liver Diseases

🇺🇸

Manhasset, New York, United States

Icahn School of Medicine at Mount Sinai Beth Israel

🇺🇸

New York, New York, United States

Weill Cornell Medical College

🇺🇸

New York, New York, United States

NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

Cumberland Research Associates LLC

🇺🇸

Fayetteville, North Carolina, United States

Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease

🇺🇸

Huntersville, North Carolina, United States

PMG Research of Rocky Mount, LLC

🇺🇸

Rocky Mount, North Carolina, United States

Piedmont Healthcare

🇺🇸

Statesville, North Carolina, United States

Consultants for Clinical Research

🇺🇸

Cincinnati, Ohio, United States

University of Cincinnati

🇺🇸

Cincinnati, Ohio, United States

Penn State University, The Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine

🇺🇸

Philadelphia, Pennsylvania, United States

University Gastroenterology

🇺🇸

Providence, Rhode Island, United States

Greenville Health System Gastroenterology and Liver Center

🇺🇸

Greenville, South Carolina, United States

Gastro One

🇺🇸

Germantown, Tennessee, United States

WR-ClinSearch, LLC

🇺🇸

Chattanooga, Tennessee, United States

Medical University of South Carolina, University Hospital

🇺🇸

Charleston, South Carolina, United States

Pinnacle Clinical Research, PLLC

🇺🇸

Austin, Texas, United States

Texas Clinical Research Institute, LLC

🇺🇸

Arlington, Texas, United States

Austin Center for Clinical Research

🇺🇸

Austin, Texas, United States

The Liver Institute at Methodist Dallas Medical Center

🇺🇸

Dallas, Texas, United States

Kelsey-Seybold Clinic

🇺🇸

Houston, Texas, United States

Houston Methodist Hospital

🇺🇸

Houston, Texas, United States

Liver Associates of Texas, P.A.

🇺🇸

Houston, Texas, United States

Research Specialists of Texas

🇺🇸

Houston, Texas, United States

Smith Clinic

🇺🇸

Houston, Texas, United States

Pinnacle Clinical Research

🇺🇸

Live Oak, Texas, United States

DHAT Research Institute

🇺🇸

Richardson, Texas, United States

Intermountain Liver Disease and Transplant Clinic

🇺🇸

Murray, Utah, United States

The University of Vermont Medical Center

🇺🇸

Burlington, Vermont, United States

Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia

🇺🇸

Newport News, Virginia, United States

University of Virginia Medical Center

🇺🇸

Charlottesville, Virginia, United States

Virginia Mason

🇺🇸

Seattle, Washington, United States

Digestive and Liver Disease Specialists

🇺🇸

Norfolk, Virginia, United States

Virginia Commonwealth University

🇺🇸

Richmond, Virginia, United States

McGuire VA Medical Center

🇺🇸

Richmond, Virginia, United States

University of Washington

🇺🇸

Seattle, Washington, United States

Royal Prince Alfred Hospital

🇦🇺

Camperdown, New South Wales, Australia

St. Vincent's Hospital Sydney

🇦🇺

Darlinghurst, New South Wales, Australia

St. George's Hospital

🇬🇧

London, United Kingdom

Westmead Hospital

🇦🇺

Westmead, New South Wales, Australia

St. Vincent's Hospital Melbourne

🇦🇺

Fitzroy, Victoria, Australia

Lyell McEwin Hospital

🇦🇺

Elizabeth Vale, South Australia, Australia

Austin Health

🇦🇺

Heidelberg, Victoria, Australia

The Alfred Hospital, Alfred Health

🇦🇺

Melbourne, Victoria, Australia

UZ Brussel

🇧🇪

Brussels, Belgium

Allgemeines Krankenhaus Wien

🇦🇹

Vienna, Austria

CUB Hopital Erasme

🇧🇪

Bruxelles, Belgium

Cliniques Universitaires UCL Saint-Luc

🇧🇪

Brussels, Belgium

University of Calgary Liver Unit (Heritage Medical Research Clinic)

🇨🇦

Calgary, Alberta, Canada

Az Maria Middelares Ghent

🇧🇪

Ghent, Belgium

GI Research

🇨🇦

Edmonton, Alberta, Canada

University of Alberta

🇨🇦

Edmonton, Alberta, Canada

LAIR Centre

🇨🇦

Vancouver, British Columbia, Canada

Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

🇨🇦

Vancouver, British Columbia, Canada

PerCuro Clinical Research Ltd.

🇨🇦

Victoria, British Columbia, Canada

South Shore Medical Arts

🇨🇦

Bridgewater, Nova Scotia, Canada

William Osler Health System-Brampton Civic Hospital

🇨🇦

Brampton, Ontario, Canada

St. Joseph's Healthcare Hamilton

🇨🇦

Hamilton, Ontario, Canada

London Health Sciences Centre - University Hospital

🇨🇦

London, Ontario, Canada

Centre Hospitalier Universitaire d'Angers

🇫🇷

Angers, France

CHU Amiens Picardie

🇫🇷

Amiens, France

Centre Hospitalier Universitaire Estaing

🇫🇷

Clermont-Ferrand, France

CHU de Montpellier, Hopital St Eloi

🇫🇷

Montpellier, France

CHU de Grenoble- Hopital Michallon

🇫🇷

Grenoble, France

Centre Hospitalier Regional Universitaire- Hopital Claude Huriez

🇫🇷

Lille, France

Hôpital Saint Joseph

🇫🇷

Marseille, France

Hopital Cochin

🇫🇷

Paris, France

Groupe Hospitalier Universitaire La Pitie Salpetriere

🇫🇷

Paris, France

Hopital Beaujon

🇫🇷

Pessac, France

Uniklinik RWTH Aachen, Medizinische Klinik III

🇩🇪

Aachen, Germany

Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil

🇫🇷

Strasbourg, France

Universitatsklinikum Frankfurt der Goethe-Universitat

🇩🇪

Frankfurt am main, Germany

Universitatsklinikum Leipzig AoR

🇩🇪

Leipzig, Germany

Alice Ho Miu Ling Nethersole Hospital

🇭🇰

Tai Po, Hong Kong

Department of Hepatology PGIMER Chandigarh

🇮🇳

Chandigarh, India

Global Clinical Reseaech Services PVT LTD

🇮🇳

Hyderabad, India

Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals

🇮🇳

Mumbai, India

Dayanand Medical College & Hospital

🇮🇳

Ludhiana, India

Fortis Flt. Lt. Rajan Dhall Hospital

🇮🇳

New Delhi, India

Institute of Liver & Biliary Sciences

🇮🇳

New Delhi, India

Emek Medical Center

🇮🇱

Afula, Israel

Rambam Health Care Campus

🇮🇱

Haifa, Israel

The Chaim Sheba Medical Center

🇮🇱

Ramat Gan, Israel

Rabin Medical Center

🇮🇱

Petaẖ Tiqwa, Israel

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

🇮🇹

Milan, Italy

Tel-Aviv Sourasky Medical Center

🇮🇱

Tel Aviv, Israel

IRCCS Istituto Clinico Humanitas

🇮🇹

Rozzano, Italy

Fukui-Ken Saiseikai Hospital

🇯🇵

Fukui, Japan

Kyushu University Hospital

🇯🇵

Fukuoka, Japan

Nara Medical University Hospital

🇯🇵

Kashihara, Japan

Kanazawa University Hospital

🇯🇵

Kanazawa, Japan

Juntendo University Shizuoka Hospital

🇯🇵

Izunokuni, Japan

Toranomon Hospital Kajigaya

🇯🇵

Kawasaki, Japan

Kumamoto Shinto General Hospital

🇯🇵

Kumamoto, Japan

Kurume University Hospital

🇯🇵

Kurume, Japan

Shinshu University Hospital

🇯🇵

Matsumoto, Japan

Toranomon Hospital

🇯🇵

Minato, Japan

Miyazaki Medical Center Hospital

🇯🇵

Miyazaki, Japan

Nara City Hospital

🇯🇵

Nara, Japan

Okayama University Hospital

🇯🇵

Okayama, Japan

Saga University Hospital

🇯🇵

Saga, Japan

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

🇯🇵

Sapporo, Japan

Tokyo Womens Medical University Hospital

🇯🇵

Shinjuku, Japan

Osaka University Hospital

🇯🇵

Suita, Japan

Yamagata University Hospital

🇯🇵

Yamagata, Japan

Ehime University Hospital

🇯🇵

Tōno, Japan

Yokohama City University Hospital

🇯🇵

Yokohama, Japan

National Hospital Organization Nagasaki Medical Center

🇯🇵

Ōmura, Japan

National Health Insurance Service- Ilsan Hospital

🇰🇷

Goyang-si, Korea, Republic of

Gangnam Severance Hospital

🇰🇷

Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center

🇰🇷

Seoul, Korea, Republic of

Korea University Guro Hospital

🇰🇷

Seoul, Korea, Republic of

Accelerium S. de R.L. de C.V.

🇲🇽

Monterrey, Mexico

Auckland City Hospital

🇳🇿

Auckland, New Zealand

Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii

🇵🇱

Bytom, Poland

Southern District Health Board - Dunedin Hospital

🇳🇿

Dunedin, New Zealand

ID Clinic Arkadiusz Pisula

🇵🇱

Mysłowice, Poland

Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

🇵🇱

Łódź, Poland

Klinical Investigations Group, LLC

🇵🇷

San Juan, Puerto Rico

Fundacion de Investigacion de Diego

🇵🇷

San Juan, Puerto Rico

VA Carribean Healthcare System

🇵🇷

San Juan, Puerto Rico

National University Health System

🇸🇬

Singapore, Singapore

Singapore General Hospital

🇸🇬

Singapore, Singapore

Changi General Hospital Pte Ltd.

🇸🇬

Singapore, Singapore

Hospital Universitario Fundacion Alcorcon

🇪🇸

Alcorcón, Spain

Hospital Universitari Vall d'Hebron

🇪🇸

Barcelona, Spain

Hospital Universitario La Paz

🇪🇸

Madrid, Spain

Hospital Clinic de Barcelona

🇪🇸

Barcelona, Spain

Hospital Universitario Puerto de Hierro Majadahonda

🇪🇸

Majadahonda, Spain

CHOP_Complejo Hospitalario Universitario de Pntevedra

🇪🇸

Pontevedra, Spain

Hospital Universitario Marques de Valdecilla

🇪🇸

Santander, Spain

Hospital Universitario Virgen del Rocio

🇪🇸

Sevilla, Spain

Consorcio Hospital General Universitario de Valencia

🇪🇸

Valencia, Spain

Hospital Universitari i Politecnic La Fe de Valencia

🇪🇸

Valencia, Spain

Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie

🇨🇭

Bern, Switzerland

Istituto Cantanale di Patologia Locarno

🇨🇭

Lugano, Switzerland

Kaohsiung Medical University Chung-Ho Memorial Hospital

🇨🇳

Kaohsiung, Taiwan

National Cheng Kung University Hospital

🇨🇳

Tainan, Taiwan

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

Chang Gung Medical Foundation-LinKou Branch

🇨🇳

Taoyuan, Taiwan

NHS Greater Glasgow and Clyde

🇬🇧

Glasgow, United Kingdom

Imperial College Healthcare NHS Trust

🇬🇧

London, United Kingdom

Abertawe Bro Morgannwg University Health Board

🇬🇧

Swansea, United Kingdom

Plymouth Hospitals NHS Trust

🇬🇧

Plymouth, United Kingdom

Research and Education, Inc.

🇺🇸

San Diego, California, United States

Medical Associates Research Group

🇺🇸

San Diego, California, United States

Kaiser Permanente

🇺🇸

San Diego, California, United States

Duke University Medical Center - Duke South Clinics

🇺🇸

Durham, North Carolina, United States

American Research Corporation, The Texas Liver Institute

🇺🇸

San Antonio, Texas, United States

California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant

🇺🇸

San Francisco, California, United States

University of California, San Francisco-Liver Clinic

🇺🇸

San Francisco, California, United States

eStudySite

🇺🇸

San Francisco, California, United States

Quality Medical Research PLLC

🇺🇸

Nashville, Tennessee, United States

Vanderbilt University Medical Center - Digestive Disease Center

🇺🇸

Nashville, Tennessee, United States

University of Utah

🇺🇸

Salt Lake City, Utah, United States

Royal Perth Hospital

🇦🇺

Perth, Western Australia, Australia

Sir Charles Gairdner Hospital

🇦🇺

Nedlands, Western Australia, Australia

University of Manitoba, Health Sciences Centre, John Buhler Research Centre

🇨🇦

Winnipeg, Manitoba, Canada

South Denver Gastroenterology, PC

🇺🇸

Englewood, Colorado, United States

Shaare Zedek Medical Center

🇮🇱

Jerusalem, Israel

Barts Health NHS Trust

🇬🇧

London, United Kingdom

Icahn School of Medicine at Mount Sinai

🇺🇸

New York, New York, United States

St. Joseph's Hospital and Medical Center

🇺🇸

Phoenix, Arizona, United States

Henry Ford Health System

🇺🇸

Detroit, Michigan, United States

King's College Hospital NHS Foundation Trust

🇬🇧

London, United Kingdom

Nottingham University Hospitals NHS Trust

🇬🇧

Nottingham, United Kingdom

Portsmouth Hospitals NHS Trust

🇬🇧

Portsmouth, United Kingdom

Florida Research Institute

🇺🇸

Lakewood Ranch, Florida, United States

McMaster University Medical Centre

🇨🇦

Hamilton, Ontario, Canada

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Toronto Center for Liver Diseases (TCLD), Toronto General Hospital

🇨🇦

Toronto, Ontario, Canada

Institute of Post Graduate Medical Education and Research (IPGMER)

🇮🇳

Kolkata, India

University Hospital, Kyoto Prefectural University of Medicine

🇯🇵

Kyoto, Japan

Mie University Hospital

🇯🇵

Tsu, Japan

Keimyung University Dongsan Medical Center

🇰🇷

Daegu, Korea, Republic of

University of Colorado Denver and Hospital

🇺🇸

Aurora, Colorado, United States

Walter Reed National Military Medical Center

🇺🇸

Bethesda, Maryland, United States

Hospital del Mar - Parc de Salut

🇪🇸

Barcelona, Spain

Iowa Digestive Disease Center, P.C.

🇺🇸

Clive, Iowa, United States

NYU Langone Medical Center

🇺🇸

New York, New York, United States

University Hospitals Cleveland Medical Center

🇺🇸

Cleveland, Ohio, United States

University of Rochester Medical Center

🇺🇸

Rochester, New York, United States

Texas Digestive Disease Consultants

🇺🇸

Dallas, Texas, United States

Inova Fairfax Medical Campus

🇺🇸

Falls Church, Virginia, United States

University of California, Davis Medical Center

🇺🇸

Sacramento, California, United States

University of Louisville Clinical Trials Unit

🇺🇸

Louisville, Kentucky, United States

Digestive Health Specialists, PA

🇺🇸

Winston-Salem, North Carolina, United States

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Arkansas Gastroenterology

🇺🇸

North Little Rock, Arkansas, United States

Integrity Clinical Research, LLC

🇺🇸

Doral, Florida, United States

Tulane University Health Sciences Center

🇺🇸

New Orleans, Louisiana, United States

Nature Coast Clinical Research

🇺🇸

Inverness, Florida, United States

Florida Hospital Transplant Institute

🇺🇸

Orlando, Florida, United States

Gastroenterology Associates of Western Michigan, P.L.C.

🇺🇸

Wyoming, Michigan, United States

Baptist Medical Center

🇺🇸

Little Rock, Arkansas, United States

Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin

🇦🇹

Graz, Austria

Universitatsklinikum Bonn (AoR)

🇩🇪

Bonn, Germany

Midas Multispecialty Hospital

🇮🇳

Nagpur, India

All India Institute of Medical Sciences

🇮🇳

New Delhi, India

Inha University Hospital

🇰🇷

Incheon, Korea, Republic of

Consultorio Médico

🇲🇽

Mexico City, Mexico

University of Massachusetts Medical School

🇺🇸

Worcester, Massachusetts, United States

Centre Hospitalier Universitaire de Toulouse- Hopital Purpan

🇫🇷

Toulouse, France

Johannes Gutenberg-Universitat

🇩🇪

Mainz, Germany

Kasturba Medical College Hospital

🇮🇳

Mangalore, India

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

🇯🇵

Hiroshima, Japan

Monash Medical Centre

🇦🇺

Clayton, Victoria, Australia

Rutgers New Jersey Medical School- Doctors Office Center

🇺🇸

Newark, New Jersey, United States

Royal Adelaide Hospital

🇦🇺

Adelaide, South Australia, Australia

UZ Leuven

🇧🇪

Leuven, Belgium

Hopital Henri Mondor

🇫🇷

Créteil, France

Prince of Wales Hospital

🇭🇰

Sha Tin, Hong Kong

The Lady Davis Carmel Medical Center

🇮🇱

Haifa, Israel

Kawasaki Medical School General Medical Center

🇯🇵

Okayama, Japan

Hokkaido University Hospital

🇯🇵

Sapporo, Japan

Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)

🇨🇦

Montréal, Quebec, Canada

CHU de Limoges- Hopital Dupuytren- Federation Hepatologie

🇫🇷

Limoges, France

Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2

🇫🇷

Nice, France

Aichi Medical University Hospital

🇯🇵

Nagakute, Japan

Hirakata Kohsai Hospital

🇯🇵

Osaka, Japan

Saiseikai Suita Hospital

🇯🇵

Suita, Japan

Seoul National University Bundang Hospital

🇰🇷

Seongnam, Korea, Republic of

Hopital de la Croix Rousse

🇫🇷

Lyon, France

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Kyungpook National University Hospital

🇰🇷

Daegu, Korea, Republic of

University of Florida Hepatology Research at CTRB

🇺🇸

Gainesville, Florida, United States

Carolinas HealthCare System Center for Liver Disease

🇺🇸

Charlotte, North Carolina, United States

Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research

🇺🇸

Memphis, Tennessee, United States

Institute of Liver Health

🇺🇸

Chandler, Arizona, United States

Huntington Medical Research Institutes (HMRI) Liver Center

🇺🇸

Pasadena, California, United States

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

University of Kansas Medical Center

🇺🇸

Kansas City, Kansas, United States

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