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NCT06632457PHASE3Recruiting

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

Boehringer Ingelheim

Start Date

11/7/2024

Completion Date

6/5/2029

Summary

This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion criteria: 1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \>18 years 2. Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants) 3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis. 4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \<5% or FibroScan® with CAP \<288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis. 5. Further inclusion criteria apply. Exclusion criteria: 1. Current or history (\<5 years) of significant alcohol consumption, defined as an average of \>140 g/week in female patients and \>210 g/week in male patients, for a period of \>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator. 2. Model of end-stage liver Disease (MELD) score \>12 due to liver disease 3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to: * Portal hypertension-related upper gastrointestinal (GI) bleeding * Ascites * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria 4. Any of the following lab test result at screening * Albumin below \<3.5 g/dL (\<35.0 g/L) * International normalised ratio (INR) \>1.3 unless due to therapeutic anticoagulants * Total bilirubin (TBL) \>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \<20% of TBL. * Alkaline phosphatase \>1.5x ULN * PLT \<100,000/µL (\<100 GI/L) 5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis 6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection 7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA)) 8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>5x ULN 9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history 10. History of liver transplantation or listed for liver transplantation 11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment 12. Further exclusion criteria apply

Interventions

COMBINATION_PRODUCT

Survodutide

COMBINATION_PRODUCT

Placebo matching survodutide

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Conditions

Metabolic Dysfunction Associated Steatohepatitis

Locations

The Institute for Liver Health II DBA Arizona Clinical Trials

Peoria, Arizona 85381

United States

Scottsdale Medical Specialists, Ltd

Scottsdale, Arizona 85258

United States

Adobe Clinical Research, LLC

Tucson, Arizona 85712

United States

Arizona Liver Health - Tucson

Tucson, Arizona 85712

United States

Del Sol Research Management, LLC

Tucson, Arizona 85715

United States

Hope Clinical Research

Canoga Park, California 91303

United States

Velocity Clinical Research-Chula Vista

Chula Vista, California 91911

United States

Southern California Research Center

Coronado, California 92118

United States

ARK Clinical Research

Fountain Valley, California 92708

United States

Velocity Clinical Research-Huntington Park

Huntington Park, California 90255

United States

310 Clinical Research

Inglewood, California 90301

United States

Velocity Clinical Research, San Diego

La Mesa, California 91942

United States

Om Research, LLC

Lancaster, California 93534

United States

Catalina Research Institute, LLC

Montclair, California 91763

United States

Clinnova Research Solutions

Orange, California 92868

United States

Fomat Medical Research

Oxnard, California 93030

United States

Cadena Care Institute, LLC

Poway, California 92064

United States

Ficramed Research Institute

Poway, California 92064

United States

Inland Empire Clinical Trials, LLC

Rialto, California 92377

United States

Metro Clinical Trials

San Bernardino, California 92404

United States

Acclaim Clinical Research

San Diego, California 92120

United States

Future Innovative Treatments

Colorado Springs, Colorado 80907

United States

South Denver Gastroenterology PC

Englewood, Colorado 80113

United States

Connecticut Gastroenterology Clinical Research Foundation

Bristol, Connecticut 06010

United States

Synergy Healthcare

Brandon, Florida 33511

United States

Access research Institute

Brooksville, Florida 34613

United States

Hi Tech and Global Research, LLC

Coral Gables, Florida 33134

United States

Cenara Clinical Research

Cutler Bay, Florida 33189

United States

Covenant Metabolic Specialists, LLC - Fort Myers

Fort Myers, Florida 33912

United States

Neoclinical Research

Hialeah, Florida 33016

United States

Evolution Clinical Trials

Hialeah Gardens, Florida 33016

United States

Global Research Associates

Homestead, Florida 33030

United States

Lake Center for Clinical Research

Lady Lake, Florida 32159

United States

Research Associates of South Florida, LLC

Miami, Florida 33134

United States

Optimus U Corporation-Miami-69452

Miami, Florida 33135

United States

Schiff Center Liver Diseases

Miami, Florida 33136

United States

BioMed Research & Medical Center

Miami, Florida 33156

United States

MplusM - Century Research

Miami, Florida 33173

United States

ECIR Miami Holdings LLC dba IMIC

Miami, Florida 33176

United States

Entrust Clinical Research

Miami, Florida 33176

United States

Floridian Clinical Research

Miami Lakes, Florida 33016

United States

Advanced Research Institute

New Port Richey, Florida 34653

United States

Charter Research

Orlando, Florida 32803

United States

Omega Research Orlando, LLC

Orlando, Florida 32808

United States

Endoscopic Research, Inc

Orlando, Florida 32828

United States

Innovation Medical Research Center

Palmetto Bay, Florida 33157

United States

MplusM - Best Choice Medical and Research Service

Pembroke Pines, Florida 33024

United States

Covenant Metabolic Specialist, LLC - Riverview

Riverview, Florida 33578

United States

Synergy Healthcare

St. Petersburg, Florida 33705

United States

Global Clinical Professionals

St. Petersburg, Florida 33714

United States

International Center for Research

Tampa, Florida 33618

United States

Charter Research

The Villages, Florida 32162

United States

Covenant Metabolic Specialists, LLC - University Park

University Park, Florida 34201

United States

Conquest Research

Winter Park, Florida 32789

United States

Florida Medical Clinic, P.A.

Zephyrhills, Florida 33542

United States

Piedmont Hospital

Atlanta, Georgia 30309

United States

Gastroenterology Associates of Central Georgia

Macon, Georgia 31201

United States

EmVenio Research Center at Prime Healthcare - Riverdale

Riverdale, Georgia 30274

United States

ASHA Clinical Research - Munster, LLC

Hammond, Indiana 46324

United States

Digestive Research Alliance of Michiana

South Bend, Indiana 46635

United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa 50265

United States

Tandem Clinical Research

Marrero, Louisiana 70072

United States

Delta Research Partners, LLC

Monroe, Louisiana 71201

United States

Louisiana Research Center, LLC

Shreveport, Louisiana 71105

United States

Clinical Research Institute of Michigan, LLC

Clinton Township, Michigan 48038

United States

West Michigan Clinical Research Center

Wyoming, Michigan 49519

United States

MNGI Digestive Health, PA

Minneapolis, Minnesota 55413

United States

ObjectiveHealth-GI Associates Research

Columbia, Missouri 65201

United States

Kansas City Research Institute

Kansas City, Missouri 64131

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Jubilee Clinical Research, Inc

Las Vegas, Nevada 89106

United States

Excel Clinical Research

Las Vegas, Nevada 89109

United States

Clinical Research of South Nevada

Las Vegas, Nevada 89121

United States

IMA Clinical Research-Warren-69742

Warren Township, New Jersey 07059

United States

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York 11215

United States

Basil Clinical

Laurelton, New York 11413

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

Coastal Research Institute, LLC

Fayetteville, North Carolina 28304

United States

Carolina Researche

Greenville, North Carolina 27834

United States

M3 Wake Research, Inc.

Raleigh, North Carolina 27612

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio 44060

United States

ObjectiveHealth-DSI Research - Springboro, LLC

Springboro, Ohio 45066

United States

Northshore Gastroenterology Research

Westlake, Ohio 44145

United States

Options Health Research

Tulsa, Oklahoma 74104

United States

US Digestive Health

Flourtown, Pennsylvania 19031

United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

US Digestive Health

Lancaster, Pennsylvania 17601

United States

US Digestive Health

Wyomissing, Pennsylvania 19610

United States

ObjectiveHealth-Columbia Digestive Health Research

Columbia, South Carolina 29204

United States

Palmetto Clinical Research

Summerville, South Carolina 29485

United States

ClinSearch, LLC

Chattanooga, Tennessee 37421

United States

Innovative Clinical Research

Clarksville, Tennessee 37040

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Texas Clinical Research Institute, LLC

Arlington, Texas 76012

United States

IMA Clinical Research Austin

Austin, Texas 78745

United States

American Research Corporation - Austin

Austin, Texas 78757

United States

Pinnacle Clinical Research - Austin

Austin, Texas 78757

United States

Velocity Clinical Research, Austin

Austin, Texas 78759

United States

Pinnacle Clinical Research, LLC

Bellaire, Texas 77401

United States

South Texas Research Institute - Brownsville

Brownsville, Texas 78520

United States

North Texas Research Institute - Dallas

Dallas, Texas 75150

United States

Zenos Clinical Research

Dallas, Texas 75230

United States

GI Alliance Research - Dallas

Dallas, Texas 75246

United States

Soma Clinical Trials

Denison, Texas 75020

United States

EmVenio Research Center at Prime Healthcare - Farmers Branch

Garden City, Texas 48135

United States

DHAT Reseach Institute

Garland, Texas 75044

United States

Pinnacle Clinical Research, LLC

Georgetown, Texas 78626

United States

Ben Taub General Hospital

Houston, Texas 77030-1608

United States

Biopharma Informatic, Inc. Research Center

Houston, Texas 77084

United States

Research Physicians Network

Houston, Texas 77089

United States

Epic Clinical Research

Lewisville, Texas 75057

United States

GI Alliance Research - Mansfield

Mansfield, Texas 76063

United States

Biopharma Informatic LLC

McAllen, Texas 78503

United States

Centex Studies, Inc.

McAllen, Texas 78504

United States

American Research Corporation at the Texas Liver Institute

San Antonio, Texas 78215

United States

Brooke Army Medical Center

San Antonio, Texas 78219

United States

HASresearch

San Antonio, Texas 78240

United States

Velocity Clinical Research, Waco

Waco, Texas 76710

United States

Objective Health-Digestive Research of Central Texas

Waco, Texas 76712

United States

ObjectiveHealth-Digestive Health Research of North Texas

Wichita Falls, Texas 76301

United States

GI Select Health Research LLC

Richmond, Virginia 23236

United States

Velocity Clinical Research, Seattle

Seattle, Washington 98105

United States

Velocity Clinical Research-Spokane-69716

Spokane, Washington 99218

United States

CIPREC

Buenos Aires, 1061

Argentina

IDIM - Instituto de Diagnostico e Investigaciones Metabolicas

Buenos Aires, C1012AAR

Argentina

Centro de Investigaciones Metabolicas (CINME)

Buenos Aires, C1056ABJ

Argentina

Buenos Aires Macula S.A.

Buenos Aires, C1061AAE

Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABB

Argentina

Glenny Corp - Centro Médico Saavedra

Buenos Aires, C1430CKE

Argentina

Hospital General de Agudos Dr. J. M. Ramos Mejia

Ciudad Autonoma Buenos Aires, C1221ADC

Argentina

Hospital Universitario Austral

Pilar, B1629ODT

Argentina

DIM Clinica Privada

Ramos Mejía, 1704

Argentina

Hospital El Cruce

San Juan Bautista, B1888

Argentina

Concord Repatriation General Hospital

Concord, New South Wales 2139

Australia

Nepean Hospital

Kingswood, New South Wales 2747

Australia

Liverpool Hospital

Liverpool, New South Wales 2170

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Monash Health

Clayton, Victoria 3168

Australia

Austin Health

Heidelberg, Victoria 3084

Australia

Royal Melbourne Hospital

Parkville, Victoria 3050

Australia

Royal Perth Hospital

Perth, Western Australia 6000

Australia

Medical University Graz

Graz, 8036

Austria

Ordensklinikum Linz GmbH

Linz, 4010

Austria

AKH - Medical University of Vienna

Vienna, 1090

Austria

Klinik Hietzing

Vienna, 1130

Austria

Klinikum Wels - Grieskirchen GmbH

Wels, 4600

Austria

ULB Hopital Erasme

Brussels, 1070

Belgium

Edegem - UNIV UZ Antwerpen

Edegem, 2650

Belgium

Ziekenhuis Oost-Limburg

Genk, 3600

Belgium

Centre Hospitalier Universitaire de Liège

Liège, 4000

Belgium

Universidade Federal do Rio de Janeiro

Barra, 21941-617

Brazil

Hospital Universitário João de Barros Barreto

Belém, 66073-005

Brazil

Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMG)

Belo Horizonte, 30130-100

Brazil

Universidade Estadual Paulista 'Julio De Mesquita Filho'

Botucatu, 18618-970

Brazil

Hospital das Clinicas da Faculdade de Medicina da USP

Cerqueira César, 05403-000

Brazil

Hospitalar Moinhos de Vento

Porto Alegre, 90035-001

Brazil

Universidade Federal do Rio Grande do Sul

Porto Alegre, 90035-903

Brazil

Hospital de Base - Fac Med de Sao Jose do Rio Preto

São José do Rio Preto, 15090-000

Brazil

Rocco E Nazato Servicos Medicos LTDA

São Paulo, 04077-020

Brazil

MHAT Sv. Ivan Rilski EOOD

Gorna Oryahovitsa, 5100

Bulgaria

Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.

Panagyurishte, 4500

Bulgaria

Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD

Sofia, 1407

Bulgaria

Diagnostic Consultative Center Alexandrovska

Sofia, 1431

Bulgaria

University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD

Sofia, 1431

Bulgaria

Medical Military Academy MHAT Sofia

Sofia, 1606

Bulgaria

Medical Center New Rehabilitation Center EOOD

Stara Zagora, 6003

Bulgaria

University of Calgary

Calgary, Alberta T2N 4N1

Canada

University of British Columbia

Vancouver, British Columbia V5Z 1M9

Canada

Viable Clinical Research

Bridgewater, Nova Scotia B4N 3N2

Canada

Toronto Liver Centre

Toronto, Ontario M6H 3M1

Canada

McGill University Health Centre (MUHC)

Montreal, Quebec H3H 2R9

Canada

Diex Recherche Québec

Québec, G1N 4V3

Canada

Edificio Fleming

La Serena, 1710209

Chile

Centro de Investigaciones Médicas UC

Santiago, 8330024

Chile

Centro de Investigaciones Clinicas Viña del Mar

Viña del Mar, 2520997

Chile

Beijing Ditan Hospital Capital Medical University

Beijing, 100015

China

Beijing Tsinghua Changgung Hospital

Beijing, 100044

China

Peking University People's Hospital

Beijing, 100044

China

Beijing Friendship Hospital

Beijing, 100050

China

Beijing Youan Hospital, Capital Medical University

Beijing, 100069

China

The First Hospital of Jilin University

Changchun, 130021

China

Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)

Changsha, 410005

China

Changzhou Third People's Hospital

Changzhou Shi, 214442

China

West China Hospital, Sichuan University

Chengdu, 610041

China

Chongqing Three Gorges Central Hospital

Chongqing, 404000

China

The First People's Hospital of Foshan

Foshan, 528000

China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, 350005

China

Guangzhou Eighth People's Hospital,Guangzhou Medical University

Guangzhou, 510000

China

Guangzhou First People's Hospital

Guangzhou, 510013

China

NanFang Hosptial

Guangzhou, 510515

China

The First Affiliated Hospital, Zhejiang University

Hangzhou, 310003

China

Zhejiang Hospital

Hangzhou, 310013

China

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, 310015

China

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, 310016

China

The First hospital of Jiaxing

Jiaxing, 314001

China

First People's hospital of Yunann Province

Kunming, 650032

China

Liaocheng People's Hospital

Liaocheng, 252000

China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, 471003

China

The First Affiliated Hospital of Nanchang University

Nanchang, 330006

China

The Second Affiliated Hospital to Nanchang University

Nanchang, 330006

China

The Second Hospital of Nanjing

Nanjing, 210003

China

Nanjing Drum Tower Hospital

Nanjing, 210008

China

Nanjing Jiangning Hospital

Nanjing, 211100

China

Ningbo Second Hospital

Ningbo, 315010

China

General Hospital of Ningxia Medical University

Ningxia, 750004

China

Pingxiang People's Hospital

Pingxiang, 337000

China

Qingdao Municipal Hospital

Qingdao, 266001

China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200025

China

Huashan Hospital, Fudan University

Shanghai, 200040

China

Shanghai General Hospital

Shanghai, 200080

China

Shanghai East Hospital

Shanghai, 200120

China

Renji Hospital Shanghai Jiaotong Univesrity School of Medicine

Shanghai, 200127

China

Shanghai Public Health Clinical Center

Shanghai, 201508

China

Renmin Hospital of Wuhan University

Shanghai, 430060

China

The Sixth People's Hospital of Shenyang

Shenyang, 110006

China

The Third People's Hospital of Shenzhen

Shenzhen, 518112

China

The Fifth People's Hospital of Suzhou

Suzhou, 215007

China

Tianjin Third Central Hospital

Tianjin, 300170

China

Tianjin Second People's Hospital

Tianjin, 300192

China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000

China

Second Affiliated Hospital of Xi'an JiaoTong University

Xi'an, 710004

China

First Affiliated Hospital of Xi'an JiaoTong University

Xi'an, 710061

China

Sixth People's Hospital of Zhengzhou

Zhengzhou, 450005

China

The Third People's Hospital of Zhenjiang

Zhenjiang, 212021

China

Krajska nemocnice Liberec a.s.

Liberec, 460 01

Czechia

Research Site s.r.o.

Pilsen, 301 00

Czechia

General Faculty Hospital, Prague

Prague, 128 08

Czechia

CHU Amiens-Picardie

Amiens, 80054

France

Centre Hospitalier Universitaire D'Angers

Angers, 49100

France

Hôpital Beaujon

Clichy, 92110

France

HOP Dijon-Bourgogne

Côte-d'Or, 21000

France

Hopital Henri Mondor

Créteil, 94000

France

Centre Hospitalier De Versailles

Le Chesnay, 78150

France

Hôpital Claude Huriez

Lille, 59000

France

Hopital De La Croix-Rousse

Lyon, 69004

France

Hôpital de l'Archet

Nice, 06200

France

Hopitaux Universitaires Pitié-Salpétrière

Paris, 75013

France

Hôpital Cochin

Paris, 75014

France

Centre Hospitalier Universitaire De Bordeaux

Pessac, 33600

France

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495

France

Hôpital Rangueil - CHU de Toulouse

Toulouse, 31059

France

Ltd "Health"

Batumi, 6010

Georgia

ISR-GEO Med Res Clin Healthycore

Tbilisi, 0112

Georgia

Charité - Universitätsmedizin Berlin

Berlin, 13353

Germany

Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH

Bochum, 44892

Germany

Universitätsklinikum Köln (AöR)

Cologne, 50937

Germany

Technische Universität Dresden

Dresden, 01307

Germany

Universitätsklinikum Frankfurt

Frankfurt, 69590

Germany

Universitätsklinikum Heidelberg

Heidelberg, 69120

Germany

Universität des Saarlandes

Homburg, 66421

Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, 23538

Germany

Otto-von-Guericke-Universität Magdeburg

Magdeburg, 39120

Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131

Germany

Universitätsklinikum Mannheim GmbH

Mannheim, 68167

Germany

Universitätsklinikum Münster

Münster, 49129

Germany

St. Josefs-Hospital Wiesbaden

Wiesbaden, 65189

Germany

Universitätsklinikum Würzburg AÖR

Würzburg, 97080

Germany

Dr. Rethy Pal Hospital

Békéscsaba, 5600

Hungary

Obudai Egeszegugyi Centrum

Budapest, 1036

Hungary

Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika

Budapest, 1082

Hungary

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, 1097

Hungary

Aryav Superspeciality Hospital

Ahemdabad, 380060

India

Post Graduate Institute of Medical Education and Research

Chandigarh, 14209-1120

India

Osmania Medical College & Hospital

Hyderabad, Afzalgunj, 500012

India

SR Kalla Memorial Hospital

Jaipur, 302001

India

Atharva Multispecialty Hospital and research Centre

Lucknow, 226003

India

Midas Multispeciality Hospital Pvt. Ltd.

Nagpur, 440010

India

Insitute of Liver and Billiary Sciences

New Delhi, 110 070

India

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

Rohtak, 124001

India

Yashoda Hospitals - Secunderabad

Secunderabad, 500003

India

Surat Institute of Digestive Sciences

Surat, 395002

India

BAPS Pramukh Swami Hospital

Surat, 395009

India

Gujarat Gastro and Vascular Hospital

Surat, 395009

India

Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico

Abbiategrasso, 20122

Italy

Policlinico S. Orsola-Malpighi

Bologna, 40138

Italy

Az.Osp. Universitaria "Ospedali Riuniti"

Foggia, 71122

Italy

Università degli Studi di Genova

Modena, 41121

Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, 90127

Italy

Fondazione Policlinico Universitario Campus Bio-medico

Rome, 00128

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Universita Degli Studi di Torino

Torino, 10126

Italy

The University of Tokyo Hospital

Bunkyō City, 113-8655

Japan

Chiba University Hospital

Chiba, 260-8677

Japan

Ehime University Hospital

Ehime, Toon, 791-0295

Japan

Fukuiken Saiseikai Hospital

Fukui, Fukui, 918-8503

Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, 810-8563

Japan

Kurume University Hospital

Fukuoka, Kurume, 830-0011

Japan

Gifu Municipal Hospital

Gifu, Gifu, 500-8513

Japan

Ogaki Municipal Hospital

Gifu, Ogaki, 503-8502

Japan

Nagano Municipal Hospital

Hanishina-gun, 381-8551

Japan

Hiroshima University Hospital

Hiroshima, 734-8551

Japan

Japan Community Health Care Organization Hokkaido Hospital

Hokkaido, Sapporo, 062-8618

Japan

Tokyo Medical University Ibaraki Medical Center

Ibaraki, Inashiki-gun, 300-0395

Japan

Tokai University Hospital

Isehara, 259-1193

Japan

Kanazawa University Hospital

Ishikawa, Kanazawa, 920-8641

Japan

Shimane University Hospital

Izumo, 693-8501

Japan

Kagoshima University Hospital

Kagoshima, Kagoshima, 890-8520

Japan

Shin-yurigaoka General Hospital

Kanagawa, Kawasaki, 215-0026

Japan

Kagawa University Hospital

Kita-gun, 761-0793

Japan

Kobe University Hospital

Kobe, 650-0017

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

Kumamoto Shinto General Hospital

Kumamoto, 862-8655

Japan

National Hospital Organization Kure Medical Center and Chugoku Cancer Center

Kure, 737-0023

Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566

Japan

University of Miyazaki Hospital

Miyazaki, 889-1692

Japan

Japanese Red Cross Musashino Hospital

Musashino, 186-8610

Japan

Shinshu University Hospital

Nagano, Matsumoto, 390-8621

Japan

Nagasaki Medical Center

Nagasaki, Omura, 856-8562

Japan

Nara Medical University Hospital

Nara, Kashihara, 634-8522

Japan

International University of Health and Welfare Narita Hospital

Narita, 286-0105

Japan

Niigata University Medical and Dental Hospital

Niigata, 951-8520

Japan

Hyogo College of Medicine Hospital

Nishinomiya, 663-8501

Japan

Okayama University Hospital

Okayama, 700-8558

Japan

Osaka City University Hospital

Osaka, 545-0051

Japan

Oita Cardiovascular Hospital

Ōita, 870-0837

Japan

Saga University Hospital

Saga, 849-8501

Japan

Osaka Rosai Hospital

Sakai, 591-8025

Japan

Seichokai Bell Land General Hospital

Sakai, 599-8247

Japan

Sapporo Kosei General Hospital

Sapporo, 060-0033

Japan

Sendai Tokushukai Hospital

Sendai, 981-3116

Japan

Iwate Medical University Hospital

Shiwa-gun, 028-3695

Japan

Hamamatsu University Hospital

Shizuoka, Hamamatsu, 431-3192

Japan

Juntendo University Shizuoka Hospital

Shizuoka, Izunokuni, 410-2295

Japan

The University of Osaka Hospital

Suita, 565-0871

Japan

Suita Hospital

Suita-Shi, 564-0013

Japan

National Hospital Organization Takasaki General Medical Center

Takasaki-shi, 370-0829

Japan

Juntendo University Hospital

Tokyo, 113-8431

Japan

Institute of Science Tokyo Hospital

Tokyo, 113-8519

Japan

Tokyo Medical University Hospital

Tokyo, 160-0023

Japan

Nihon University Itabashi Hospital

Tokyo, 173-8610

Japan

Nippon Medical School Hospital

Tokyo, Bunkyo-ku, 113-8603

Japan

Toranomon Hospital

Tokyo, Minato-ku, 105-8470

Japan

Mie University Hospital

Tsu, 514-8507

Japan

Wakayama Medical University Hospital

Wakayama, 641-8509

Japan

Yokohama City University Hospital

Yokohama, 236-0004

Japan

The Speciality Hospital (TSH)

Amman, 11194

Jordan

Jordan University Hospital

Jordan, 13046

Jordan

Asfendiyarov Kazakh National Medical University

Almaty, 050000

Kazakhstan

Institute of Gastroenterology, Hepatology and Metabolism LLP

Almaty, 050026

Kazakhstan

Hospital Ampang

Ampang, 68000

Malaysia

Hospital Universiti Sains Malaysia

Kota Bharu, 16150

Malaysia

University Malaya Medical Centre

Kuala Lumpur, 59100

Malaysia

Queen Elizabeth Hospital

Putrajaya, 0000

Malaysia

Centro de Investigacion Clinica del Pacifico (CICPA)

Acapulco de Juárez, 39670

Mexico

Centro de Investigación y Gastroenterología

Col. Xoco, 03339

Mexico

Instituto de Diabetes, Obesidad y Nutrición S.C.

Cuernavaca, 62250

Mexico

Clinicos Asociados BOCM SC

Mexico City, 03300

Mexico

Centro de Investigación y Gastroenterología

Mexico City, 06700

Mexico

Medical Care and Research

Mérida, 97070

Mexico

Practice Dr Rosa Isela Luna Ceballos

Veracruz, 91910

Mexico

Centro de Alta Especialidad del Estado de Veracruz

Xalapa, 91020

Mexico

Albert SchweitzerZiekenhuis

Dordrecht, 3318 AT

Netherlands

Erasmus Medisch Centrum

Rotterdam, 3015 GD

Netherlands

Franciscus Gasthuis

Schiedam, 3118 JH

Netherlands

New Zealand Clinical Research (NZCR)

Grafton, Auckland 1010

New Zealand

Middlemore Hospital

Papatoetoe, Auckland 2025

New Zealand

Christchurch Hospital

Christchurch, Canterbury 8140

New Zealand

Waikato Hospital

Hamilton, Waikato Region 3240

New Zealand

Medical Centre FutureMeds Krakow

Krakow, 31-501

Poland

Santa SP. z o.o

Lodz, 90-302

Poland

FutureMeds Lodz

Lodz, 91-363

Poland

Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie

Lublin, 20-081

Poland

ID Clinic

Mysłowice, 41-400

Poland

FutureMeds Warszawa Centrum

Warsaw, 00-215

Poland

Bodyclinic sp. z o.o. sp.k.

Warsaw, 03-712

Poland

FutureMeds Wroclaw

Wroclaw, 53-673

Poland

EMC Instytut Medyczny S.A. - Wroclaw

Wroclaw, 54-144

Poland

Klinical Investigations Group, LLC

San Juan, 00909

Puerto Rico

Latin Clinical Trial Center

San Juan, 00909

Puerto Rico

FDI Clinical Research

San Juan, 00927

Puerto Rico

Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"

Cluj-Napoca, 400162

Romania

Spital Judetean De Urgenta Satu Mare

Satu Mare, 440055

Romania

King Faisal Specialist Hospital and Research Center

Riyadh, 11564

Saudi Arabia

King Abdulaziz Medical City, National Guard Health Affairs

Riyadh, 14611

Saudi Arabia

National University Hospital

Singapore, 119074

Singapore

Singapore General Hospital

Singapore, 169608

Singapore

Changi General Hospital

Singapore, 529889

Singapore

Practice Dr Naeem Moosa

Johannesburg, 1827

South Africa

Inspired GI Care

Plumstead, 7800

South Africa

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, 14584

South Korea

Pusan National University Hospital

Busan, 49241

South Korea

Inha University Hospital

Incheon, 22332

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Asan Medical Center

Seoul, 05505

South Korea

SMG-SNU Boramae Medical Center

Seoul, 07061

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Samsung Medical Center

Seoul, 6351

South Korea

Chung-Ang University Hospital

Seoul, 6973

South Korea

Yonsei University Wonju Severance Christian Hospital

Wŏnju, 26426

South Korea

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Clínic de Barcelona

Barcelona, 08036

Spain

Hospital Universitario Reina Sofía

Córdoba, 14004

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Puerta de Hierro

Majadahonda, 28222

Spain

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, 36071

Spain

Hospital Clínico de Santiago

Santiago de Compostela, 15706

Spain

Fondazione Epatocentro Ticino

Arzo, 6900

Switzerland

Hopitaux Universitaires de Geneve (HUG)

Geneva, 1205

Switzerland

University Hospital Zurich

Zurich, 8091

Switzerland

Changhua Christian Hospital

Changhua, 50006

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsuing City, 80756

Taiwan

Chung Shan Medical University Hospital

Taichung, 40201

Taiwan

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

National Cheng Kung University Hospital

Tainan, 70403

Taiwan

Chi Mei Medical Center

Tainan, 71004

Taiwan

National Taiwan University Hospital

Taipei, 10048

Taiwan

Taipei Medical University Hospital

Taipei, 110301

Taiwan

Taipei Veterans General Hospital

Taipei, 112201

Taiwan

Chang Gung Medical Foundation (CGMF) - Linkou Bran

Taoyuan, 33305

Taiwan

Hacettepe Universitesi Tip Fakultesi

Ankara, 06230

Turkey (Türkiye)

Gazi Universitesi Tip Fakultesi

Ankara, 06560

Turkey (Türkiye)

Uludag Universitesi Tip Fakultesi

Bursa, 16059

Turkey (Türkiye)

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

Fatih, 34093

Turkey (Türkiye)

Koc Universitesi Hastanesi

Istanbul, 34010

Turkey (Türkiye)

Memorial Bahçelievler Hospital

Istanbul, 34180

Turkey (Türkiye)

Ege Universitesi Tip Fakultesi

Izmir, 35030

Turkey (Türkiye)

Recep Tayyip Erdogan Universitesi Egitim ve Arastirma Hastanesi

Rize, 53020

Turkey (Türkiye)

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN

United Kingdom

Velocity Clinical Research, Bristol

Bristol, BS82RA

United Kingdom

Frimley Park Hospital

Camberley, GU16 7UJ

United Kingdom

Derby City General Hospital

Derby, DE22 3NE

United Kingdom

Queen Elizabeth Hospital Birmingham

Edgbaston, Birmingham, B15 2WB

United Kingdom

Royal Devon and Exeter Hospital, Wonford

Exeter, EX2 5AX

United Kingdom

Panthera Biopartners - Glasgow

Glasgow, G51 4TY

United Kingdom

St Luke's Cancer Centre

Guildford, GU2 7XX

United Kingdom

Hull Royal Infirmary

Hull, HU3 2JZ

United Kingdom

Aintree University Hospital

Liverpool, L9 7Al

United Kingdom

Royal Free Hospital

London, NW32PF

United Kingdom

King's College Hospital

London, SE5 9RS

United Kingdom

Chelsea and Westminster Hospital

London, SW10 9NH

United Kingdom

Newcastle General Hospital

Newcastle upon Tyne, NE4 6BE

United Kingdom

Accellacare North London

Northwood, HA6 2RN

United Kingdom

Accellacare - South London

Orpington, London, BR5 3QG

United Kingdom

Panthera Biopartners - Preston

Preston, PR2 9RB

United Kingdom

Panthera Biopartners - Rochdale

Rochdale, OL11 4AU

United Kingdom

Panthera Biopartners - Sheffield

Sheffield, S2 5FX

United Kingdom

Southampton General Hospital

Southampton, SO16 6YD

United Kingdom

St George's Hospital

Tooting, London, SW17 0QT

United Kingdom

Panthera Biopartners - York

York, YO24 4LJ

United Kingdom