Clinical trial NCT06632457: LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Official title: A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metabolic Dysfunction Associated Steatohepatitis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-10-09
Enrollment: 1590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: 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 \<90,000/µL (\<90 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

Primary outcomes:
measure: Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH
timeFrame: up to 4.5 years.
Secondary outcomes:
measure: Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score
timeFrame: At baseline and at Week 76.
measure: Key secondary endpoint: Percentage change from baseline in body weight
timeFrame: At baseline and at Week 76.
measure: Key secondary endpoint: Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) (%) in participants with type 2 diabetes mellitus (T2DM) at baseline
timeFrame: At baseline and at Week 76.
measure: Key secondary endpoint: Absolute change from baseline in liver stiffness (kPa) in FibroScan® vibration-controlled transient elastography (VCTE)
timeFrame: At baseline and at Week 76.
measure: Percentage change from baseline in liver stiffness in FibroScan® VCTE
timeFrame: At baseline and at Week 76.
measure: Time to first occurrence of progression to CSPH
timeFrame: up to 4.5 years.
measure: Time to first occurrence of any of the hepatic decompensation events (ascites, HE, or portal hypertension-related upper GI bleeding), or worsening of MELD score to ≥15
timeFrame: up to 4.5 years.
measure: Occurrence of all-cause hospitalisation (first and recurrent)
timeFrame: up to 4.5 years.
measure: Time to first occurrence of any of the adjudicated components of the composite endpoint 5-point major adverse cardiac event (5P-MACE)
timeFrame: up to 4.5 years.
measure: Absolute changes from baseline in lipids (mg/dL)
timeFrame: At baseline and at Week 76.
measure: Absolute change from baseline in aspartate aminotransferase (AST) (U/L)
timeFrame: At baseline and at Week 76.
measure: Absolute change from baseline in alanine aminotransferase (ALT) (U/L)
timeFrame: At baseline and at Week 76.
measure: Absolute change from baseline in liver stiffness (kPa) assessed by magnetic resonance elastography (MRE)
timeFrame: At baseline and at Week 76.
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: The Institute for Liver Health, LLC
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health, LLC
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management, LLC
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Chula Vista
country: United States
facility: Velocity Clinical Research-Chula Vista-67286
state: California
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Fountain Valley
country: United States
facility: ARK Clinical Research
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research-Huntington Park-68988
state: California
city: Inglewood
country: United States
facility: 310 Clinical Research
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research, San Diego
state: California
city: Lancaster
country: United States
facility: Om Research, LLC
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC-Montclair-69754
state: California
city: Orange
country: United States
facility: Clinnova Research Solutions
state: California
city: Orange
country: United States
facility: Knowledge Research Center
state: California
city: Oxnard
country: United States
facility: Fomat Medical Research
state: California
city: Poway
country: United States
facility: Cadena Care Institute, Llc
state: California
city: Poway
country: United States
facility: Ficramed Research Institute
state: California
city: Rialto
country: United States
facility: Inland Empire Clinical Trials, LLC
state: California
city: San Bernardino
country: United States
facility: Metro Clinical Trials
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Future Innovative Treatments
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology PC
state: Colorado
city: Bristol
country: United States
facility: Connecticut Gastroenterology Clinical Research Foundation
state: Connecticut
city: Bradenton
country: United States
facility: Synergy Healthcare
state: Florida
city: Brandon
country: United States
facility: Synergy Healthcare
state: Florida
city: Brooksville
country: United States
facility: Access research Institute
state: Florida
city: Coral Gables
country: United States
facility: Hi Tech and Global Research, LLC
state: Florida
city: Cutler Bay
country: United States
facility: Top Medical Research, Inc
state: Florida
city: Fort Myers
country: United States
facility: Covenant Metabolic Specialists, LLC-Fort Myers-69019
state: Florida
city: Hialeah Gardens
country: United States
facility: Evolution Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Floridian Clinical Research-Hialeah-66084
state: Florida
city: Hialeah
country: United States
facility: Neoclinical Research
state: Florida
city: Homestead
country: United States
facility: Global Research Associates
state: Florida
city: Lady Lake
country: United States
facility: ObjectiveHealth-Lake Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida, LLC
state: Florida
city: Miami
country: United States
facility: Optimus U Corporation-Miami-69452
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: BioMed Research & Medical Center
state: Florida
city: Miami
country: United States
facility: MplusM - Century Research
state: Florida
city: Miami
country: United States
facility: ECIR Miami Holdings LLC dba IMIC
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: Orlando
country: United States
facility: Charter Research
state: Florida
city: Orlando
country: United States
facility: Endoscopic Research, Inc
state: Florida
city: Orlando
country: United States
facility: Omega Research Orlando, LLC
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: MplusM - Best Choice Medical and Research Service
state: Florida
city: Saint Petersburg
country: United States
facility: Global Clinical Professionals
state: Florida
city: Sarasota
country: United States
facility: Covenant Metabolic Specialists, LLC-Sarasota-68343
state: Florida
city: Tampa
country: United States
facility: International Center for Research
state: Florida
city: The Villages
country: United States
facility: Charter Research
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Gainesville
country: United States
facility: Center for Advanced Research & Education
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Riverdale
country: United States
facility: EmVenio Research-Atlanta-69582
state: Georgia
city: Hammond
country: United States
facility: ASHA Clinical Research - Munster, LLC
state: Indiana
city: South Bend
country: United States
facility: Digestive Research Alliance of Michiana
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
city: Minneapolis
country: United States
facility: MNGI Digestive Health, PA
state: Minnesota
city: Columbia
country: United States
facility: ObjectiveHealth-GI Associates Research
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Gastroenterology & Hepatology Physicians Group
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Jubilee Clinical Research, Inc
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: Warren
country: United States
facility: IMA Clinical Research-Warren-69742
state: New Jersey
city: Brooklyn
country: United States
facility: New York Methodist Hospital in Brooklyn
state: New York
city: Inwood
country: United States
facility: Basil Clinical
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Fayetteville
country: United States
facility: Coastal Research Institute, LLC
state: North Carolina
city: Greenville
country: United States
facility: Carolina Digestive Diseases
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research Inc.
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Springboro
country: United States
facility: ObjectiveHealth-DSI Research
state: Ohio
city: Westlake
country: United States
facility: Northshore Gastroenterology Research
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research
state: Oklahoma
city: Flourtown
country: United States
facility: US Digestive Health
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: US Digestive Health
state: Pennsylvania
city: Columbia
country: United States
facility: ObjectiveHealth-Columbia Digestive Health Research
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Clarksville
country: United States
facility: Premier Medical Group
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Austin
country: United States
facility: IMA Clinical Research Austin
state: Texas
city: Austin
country: United States
facility: Pinnacle Clinical Research - Austin
state: Texas
city: Austin
country: United States
facility: Velocity Clinical Research, Austin
state: Texas
city: Bellaire
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Brownsville
country: United States
facility: South Texas Research Institute-Brownsville-68426
state: Texas
city: Dallas
country: United States
facility: Zenos Clinical Research
state: Texas
city: Dallas
country: United States
facility: GI Alliance
state: Texas
city: Denison
country: United States
facility: Soma Clinical Trials
state: Texas
city: Farmers Branch
country: United States
facility: EmVenio Research Center at Prime Healthcare- Dallas
state: Texas
city: Garland
country: United States
facility: DHAT Reseach Institute
state: Texas
city: Georgetown
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Houston
country: United States
facility: HCA Research
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, Inc. Research Center
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research
state: Texas
city: McAllen
country: United States
facility: Biopharma Informatic LLC
state: Texas
city: McAllen
country: United States
facility: Centex Studies, Inc.-Mcallen-66872
state: Texas
city: Mesquite
country: United States
facility: North Texas Research Institute - Dallas
state: Texas
city: Pasadena
country: United States
facility: Office of Rukan Daccak, MD
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: HASresearch
state: Texas
city: Waco
country: United States
facility: Objective Health-Digestive Research of Central Texas
state: Texas
city: Wichita Falls
country: United States
facility: ObjectiveHealth-Digestive Health Research of North Texas
state: Texas
city: Draper
country: United States
facility: Physicians' Research Options. LLC
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Richmond
country: United States
facility: GI Select Health Research LLC
state: Virginia
city: Seattle
country: United States
facility: Velocity Clinical Research-Seattle-69881
state: Washington
city: Spokane
country: United States
facility: Velocity Clinical Research-Spokane-69716
state: Washington
city: Buenos Aires
country: Argentina
facility: CINME Centro de Investigaciones Metabólicas
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Buenos Aires Macula S.A.
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Médico Saavedra
city: Florencio Varela
country: Argentina
facility: Hospital El Cruce
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
city: Ramos Mejía
country: Argentina
facility: DIM Clinica Privada
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Graz
country: Austria
facility: Medical University of Graz State Hospital - University Hospital Graz
city: Linz
country: Austria
facility: KH der Barmherzigen Schwestern Linz
city: Vienna
country: Austria
facility: AKH - Medical University of Vienna
city: Wels
country: Austria
facility: Klinikum Wels - Grieskirchen GmbH
city: Wien
country: Austria
facility: Hospital Hietzing
city: Anderlecht
country: Belgium
facility: ULB Hopital Erasme
city: Edegem
country: Belgium
facility: Edegem - UNIV UZ Antwerpen
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Belem
country: Brazil
facility: Hospital Universitário João de Barros Barreto
city: Cerqueira Cesar
country: Brazil
facility: Hospital das Clinicas da FMUSP
city: Porto Alegre
country: Brazil
facility: Associação Hospitalar Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
city: Sao Jose Do Rio Preto
country: Brazil
facility: Hospital de Base - Fac Med de Sao Jose do Rio Preto
city: Gorna Oryahovitsa
country: Bulgaria
facility: MHAT Sv. Ivan Rilski EOOD
city: Panagyurishte
country: Bulgaria
facility: Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University multi-profile Hospital for active treatment Tokuda Hospital
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Alexandrovska
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment St. Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: Medical Military Academy MHAT Sofia
city: Stara Zagora
country: Bulgaria
facility: Medical Center New Rehabilitation Center EOOD
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Bridgewater
country: Canada
facility: Viable Clinical Research
state: Nova Scotia
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
city: Quebec
country: Canada
facility: Diex Recherche Québec
city: La Serena
country: Chile
facility: Edificio Fleming
city: Santiago
country: Chile
facility: Centro de Investigaciones Médicas UC
city: Vina del Mar
country: Chile
facility: Instituto Oncologico Ltda.
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
city: Changzhou Shi
country: China
facility: Changzhou Third People's Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital,Guangzhou Medical University
city: Guangzhou
country: China
facility: NanFang Hosptial
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
city: Hangzhou
country: China
facility: Zhejiang Hospital
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
city: Jiaxing
country: China
facility: The First hospital of Jiaxing
city: Kunming
country: China
facility: First People's hospital of Yunann Province
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanchang
country: China
facility: The Second Affiliated Hospital to Nanchang University
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Nanjing Jiangning Hospital
city: Ningbo
country: China
facility: Ningbo Second Hospital
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong Univesrity School of Medicine
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Shenyang
country: China
facility: The Sixth People's Hospital of Shenyang
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Suzhou
country: China
facility: The Fifth People's Hospital of Suzhou
city: Tianjin Shi
country: China
facility: Tianjin Second People's Hospital
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
city: Wuhan
country: China
facility: Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Xi'An
country: China
facility: Second Affiliated Hospital of Xi'an JiaoTong University
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an JiaoTong University
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Zhejiang
country: China
facility: The First Affiliated Hosptial of Wenzhou Medical University
city: Zhengzhou
country: China
facility: Sixth People's Hospital of Zhengzhou
city: Zhenjiang
country: China
facility: The Third People's Hospital of Zhenjiang
city: Liberec
country: Czechia
facility: Regional Hospital Liberec
city: Plzen
country: Czechia
facility: RESEARCH SITE s.r.o.
city: Praha 2
country: Czechia
facility: General Faculty Hospital, Prague
city: Clichy-Sous-Bois
country: France
facility: Hopitaux Universitaires Paris Nord Val de Seine - Hopital Beaujon
city: Côte-d'Or
country: France
facility: HOP Dijon-Bourgogne
city: Haute-Garonne
country: France
facility: HOP Rangueil
city: Le Chesnay
country: France
facility: Centre Hospitalier De Versailles
city: Lyon
country: France
facility: HOP Croix-Rousse
city: Maine-et-Loire
country: France
facility: CHU D´Angers - Hôpital Larrey
city: Nord-Pas-de-Calais
country: France
facility: HOP Claude Huriez
city: Paris
country: France
facility: CHU - Groupe Hospitalier Pitié-Salpétrière
city: Île-de-France
country: France
facility: HOP Henri-Mondor
city: Batumi
country: Georgia
facility: Ltd "Health"
city: Tbilisi
country: Georgia
facility: ISR-GEO Med Res Clin Healthycore
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin KöR
city: Bochum
country: Germany
facility: Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
city: Dresden
country: Germany
facility: Technische Universität Dresden
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Homburg
country: Germany
facility: Universität des Saarlandes
city: Köln Lindenthal
country: Germany
facility: Universitätsklinikum Köln (AöR)
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim GmbH
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wiesbaden
country: Germany
facility: St. Josefs-Hospital, Wiesbaden
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg AÖR
city: Budapest
country: Hungary
facility: Obudai Egeszegugyi Centrum
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
city: Ahemdabad
country: India
facility: Aryav Superspeciality Hospital
city: Chandigarh
country: India
facility: Institute of Post Graduate Medical Education and Research
city: Hyderabad
country: India
facility: Osmania Medical College & Hospital
city: Jaipur
country: India
facility: SR Kalla Memorial Hospital
city: Jaipur
country: India
facility: ManglamPlus Medicity Hospital
city: Kanpur
country: India
facility: G S V M, Kanpur
city: Lucknow
country: India
facility: Atharva Multispecialty Hospital and research Centre
city: Nagpur
country: India
facility: Midas Multispeciality Hospital Pvt Ltd
city: New Delhi
country: India
facility: Insitute of Liver and Billiary Sciences
city: Rohtak
country: India
facility: Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
city: Secunderabad
country: India
facility: Yashoda Hospitals - Secunderabad
city: Surat
country: India
facility: Surat Institute of Digestive Sciences
city: Surat
country: India
facility: BAPS Pramukh Swami Hospital
city: Surat
country: India
facility: Gujarat Gastro and Vascular Hospital
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi
city: Milano
country: Italy
facility: Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
city: Modena
country: Italy
facility: Università degli Studi di Genova
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Palermo
country: Italy
facility: Policlinico "Paolo Giaccone"
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-medico
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: Turin
country: Italy
facility: AO Città della Salute e Scienza
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Ehime, Toon
country: Japan
facility: Ehime University Hospital
city: Fukui, Fukui
country: Japan
facility: Fukuiken Saiseikai Hospital
city: Fukuoka, Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka, Kurume
country: Japan
facility: Kurume University Hospital
city: Gifu, Gifu
country: Japan
facility: Gifu Municipal Hospital
city: Gifu, Ogaki
country: Japan
facility: Ogaki Municipal Hospital
city: Hanishina-gun
country: Japan
facility: Nagano Municipal Hospital
city: Hiroshima, Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Sapporo Kosei General Hospital
city: Hokkaido, Sapporo
country: Japan
facility: Japan Community Health Care Organization Hokkaido Hospital
city: Ibaraki, Inashiki-gun
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Ishikawa, Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Ishikawa, Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Izumo
country: Japan
facility: Shimane University Hospital
city: Kagawa, Takamatsu
country: Japan
facility: Takamatsu Red Cross Hospital
city: Kagoshima, Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kanagawa, Kawasaki
country: Japan
facility: Shin-yurigaoka General Hospital
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kumamoto, Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kumamoto, Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center
city: Kyoto, Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Mie, Tsu
country: Japan
facility: Mie University Hospital
city: Miyazaki, Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Nagano, Matsumoto
country: Japan
facility: Shinshu University Hospital
city: Nagasaki, Omura
country: Japan
facility: Nagasaki Medical Center
city: Nara, Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hospital
city: Oita
country: Japan
facility: Oita Cardiovascular Hospital
city: Okayama, Kurashiki
country: Japan
facility: Kawasaki Medical School Hospital
city: Osaka, Suita
country: Japan
facility: Suita Hospital
city: Osaka, Suita
country: Japan
facility: The University of Osaka Hospital
city: Saga, Saga
country: Japan
facility: Saga University Hospital
city: Sakai
country: Japan
facility: Osaka Rosai Hospital
city: Sakai
country: Japan
facility: Seichokai Bell Land General Hospital
city: Sendai-shi
country: Japan
facility: Sendai Tokushukai Hospital
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Shizuoka, Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
city: Shizuoka, Izunokuni
country: Japan
facility: Juntendo University Shizuoka Hospital
city: Takasaki-shi
country: Japan
facility: National Hospital Organization Takasaki General Medical Center
city: Tokyo, Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo, Minato-ku
country: Japan
facility: Toranomon Hospital
city: Tokyo, Musashino
country: Japan
facility: Japanese Red Cross Musashino Hospital
city: Tokyo, Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Amman
country: Jordan
facility: The Speciality Hospital (TSH)
city: Jordan
country: Jordan
facility: Jordan University Hospital
city: Bucheon-Si
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Busan
country: Korea, Republic of
facility: Pusan National Univ. Hosp
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Wonju-Si
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Ampang Jaya
country: Malaysia
facility: Hospital Ampang
city: Kelantan
country: Malaysia
facility: Universiti Sains Malaysia Hospital
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
city: Putrajaya
country: Malaysia
facility: Queen Elizabeth Hospital-Kota Kinabalu-40735
city: Acapulco de Juarez
country: Mexico
facility: Centro de Investigacion Clinica del Pacifico (CICPA)
city: Benito Juarez, Mexico
country: Mexico
facility: Clinicos Asociados BOCM SC
city: Merida
country: Mexico
facility: Medical Care and Research
city: Mexico City
country: Mexico
facility: Centro de Investigación y Gastroenterología
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazón S.C.
city: Grafton
country: New Zealand
facility: New Zealand Clinical Research (NZCR)
state: Auckland
city: Papatoetoe
country: New Zealand
facility: Middlemore Hospital
state: Auckland
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
state: Canterbury
city: Hamilton
country: New Zealand
facility: Waikato Hospital
state: Waikato
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
city: Lodz
country: Poland
facility: FutureMeds Lodz
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
city: Myslowice
country: Poland
facility: ID Clinic
city: Warsaw
country: Poland
facility: FutureMeds Warszawa Centrum
city: Warszawa
country: Poland
facility: Bodyclinic
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A.-Wroclaw-70301
city: Wrocław
country: Poland
facility: FutureMeds Wroclaw
city: Łódź
country: Poland
facility: Santa Familia PTG Łódź
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group, LLC
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
city: Bucuresti
country: Romania
facility: Hightech Medical Services
city: Cluj-Napoca
country: Romania
facility: Cluj Napoca Clinical County Hospital
city: Cluj-Napoca
country: Romania
facility: Regional Institute of Gastroenterology Hepatology "Prof. Dr. O. Fodor"
city: Iasi
country: Romania
facility: Gastromedica Srl
city: Ramah
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Center
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City, National Guard Health Affairs
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Johannesburg
country: South Africa
facility: Practice Dr Naeem Moosa
city: Plumstead
country: South Africa
facility: Inspired GI Care
city: A Coruña
country: Spain
facility: Hospital A Coruña
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía-Córdoba-40500
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
city: Pontevedra
country: Spain
facility: Complexo Hospitalario Universitario de Pontevedra
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico de Santiago
city: Tarragona
country: Spain
facility: Hospital Universitari Joan XXIII
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve (HUG)
city: Lugano
country: Switzerland
facility: Clinica Luganese Moncucco
city: Zuerich
country: Switzerland
facility: University Hospital Zurich
city: Changhua City
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Kaohsuing City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung City
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan City
country: Taiwan
facility: National Cheng Kung University Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation (CGMF) - Linkou Bran
city: Ankara
country: Turkey
facility: Ankara Üniversitesi Tıp Fakültesi Hastanesi
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi
city: Bahcelievler
country: Turkey
facility: Memorial Bahçelievler Hospital
city: Bursa
country: Turkey
facility: Uludag University Medicine Faculty Departmant of Dermatology
city: Fatih
country: Turkey
facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Koc Universitesi Hastanesi
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan Universitesi Egitim ve Arastirma Hastanesi
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Acomb, York
country: United Kingdom
facility: Panthera Biopartners - York
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: Velocity Clinical Research, Bristol
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Dagenham
country: United Kingdom
facility: Elpida Clinical Trials - Parsloes Hub
city: Derby
country: United Kingdom
facility: Derby City General Hospital
city: Enfield
country: United Kingdom
facility: Panthera Biopartners - North London
city: Frimley
country: United Kingdom
facility: Frimley Health NHS Foundation Trust - Frimley Park Hospital
city: Glasgow
country: United Kingdom
facility: Panthera Biopartners - Glasgow
city: Guildford
country: United Kingdom
facility: Royal Surrey NHS Foundation Trust - St Luke's Cancer Centre
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
city: London
country: United Kingdom
facility: Elpida Clinical Trials - St Andrews Medical Practice
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust - Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Newcastle
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
city: Northwood
country: United Kingdom
facility: Accellacare North London
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Orpington
country: United Kingdom
facility: Accellacare South London
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust - Queen Alexandra Hospital
city: Preston
country: United Kingdom
facility: Panthera Biopartners - Preston
city: Rochdale
country: United Kingdom
facility: Panthera Biopartners - Manchester
city: Sheffield
country: United Kingdom
facility: Panthera Biopartners - Sheffield
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Stockton-on-Tees
country: United Kingdom
facility: Futuremeds -Teesside
city: Wallasey
country: United Kingdom
facility: Elpida St George's Medical Centre
Study officials:
References: