Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis

NCT ID: NCT04365868

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-22

Study Completion Date

2025-04-10

Brief Summary

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This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.

Detailed Description

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Conditions

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Prevention of Esophageal Varices NASH - Nonalcoholic Steatohepatitis Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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belapectin 2 mg/kg lean body mass (LBM)

Phase 2b: Belapectin 2 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months)

Phase 3: The patient will be switched to the optimal dose

Group Type EXPERIMENTAL

belapectin

Intervention Type DRUG

intravenous

belapectin 4 mg/kg lean body mass (LBM)

Phase 2b: Belapectin 4 mg/kg lean body mass administered intravenously (IV) every other week for 78 weeks (18 months)

Phase 3: The patient will be switched to the optimal dose

Group Type EXPERIMENTAL

belapectin

Intervention Type DRUG

intravenous

Placebo

Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months)

Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

intravenous

Interventions

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belapectin

intravenous

Intervention Type DRUG

Placebo

intravenous

Intervention Type DRUG

Other Intervention Names

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GR-MD-02 galactoarabino rhamnogalacturonate

Eligibility Criteria

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Inclusion Criteria

Each subject must meet all of the following criteria to be enrolled in this study:

1. Is male or female, ≥ 18 and ≤ 75 years of age at the time of Screening.
2. Is willing and able to provide written informed consent prior to the initiation of any study-specific procedures.
3. Has evidence of portal hypertension, with either one of the following:

1. platelet count \<150,000/mm3

OR
2. documented hepatic venous pressure gradient (HVPG) measurement \>6 mmHg

OR
3. at least two of the following:

* spleen size ≥14 cm (documented by ultrasound, MRI, or CT scan)
* abdominal collateral circulation (documented by ultrasound, MRI, or CT scan or physical examination, ie, caput medusae)
* documented liver transient elastography (eg, FibroScan) ≥20 kilopascals (kPa).
* aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>1.
4. Has a history confirming nonalcoholic steatohepatitis (NASH) cirrhosis, with at least one of the following:

* There is a historical liver biopsy showing cirrhosis with steatohepatitis. There is no evidence for a competing etiology for the cirrhosis.
* There is a historical liver biopsy showing steatohepatitis, and there is evidence of cirrhosis from clinical or imaging data or a second liver biopsy showing cirrhosis without all features of NASH (as the histological NASH lesions may have burnt out). There is no evidence for a competing etiology. There is at least 1 co-existing metabolic comorbidity at Screening: obesity (with either body mass index \[BMI\] ≥30 kg/m2 or waist circumference ≥102 cm \[40 in, men\] or ≥88 cm \[35 in, women\], or by ethnically appropriate cutpoints); hypertension (either on anti hypertensive drug therapy for at least 1 year or systolic/diastolic blood pressure (BP) \>140/80 mm Hg); Type 2 diabetes (glycated hemoglobin \[HbA1c\] ≥6.5%, or on anti-diabetic medication for at least 1 year); or dyslipidemia (triglycerides ≥150 mg/dL or on drug therapy for hypertriglyceridemia for at least 6 months; high-density lipoprotein cholesterol ≤40 mg/dL \[men\] or ≤50 mg/dL \[women\]) to corroborate a diagnosis of nonalcoholic fatty liver disease (NAFLD).
* There is a historical liver biopsy showing cirrhosis with steatosis but not steatohepatitis. There is no evidence for a competing etiology. There are at least 2 co-existing (or history of) metabolic comorbidities (with obesity or diabetes being one of them) to corroborate a diagnosis of NAFLD.
* There is a historical liver biopsy showing steatosis but now with cirrhosis either by clinical examination, imaging, or biopsy. If there is a current biopsy, it does not show evidence of steatosis or steatohepatitis as histological lesions may have burned out. There is no evidence for a competing etiology. There are at least 2 co existing (or history of) metabolic comorbidities (with obesity or diabetes being one of them) to corroborate a diagnosis of NAFLD.
* Patient with cirrhosis with current or previous imaging showing steatosis. There is no liver histology available. There is no evidence for a competing etiology. There are at least two co-existing or history of metabolic comorbidities with obesity or diabetes being one of them to corroborate a diagnosis of NAFLD.
* For patients not meeting the above mentioned criteria, a screening liver biopsy is necessary.

Note: All liver biopsy blocks and/or slides for eligibility assessments (including those from historical biopsies) will be reviewed by the central study pathologist while the subject is in Screening. Results from the central study pathologist must be available before the subject is randomized.
5. Absence of hepatocellular carcinoma (HCC) by valid imaging (eg, ultrasound, CT scan, or MRI) within 6 months prior to randomization. If no such imaging result is available, then ultrasound imaging should be performed as part of standard of care.
6. Patients with diabetes mellitus can be enrolled, if they are adequately controlled on a stable dose or doses of antidiabetic medication(s) for at least 3 months before Screening, and their screening HbA1c is ≤9.5%.
7. Patients on vitamin E or pioglitazone can be enrolled if they are on a stable dose and regimen for at least 3 months before screening, and the dose is expected to be held constant during the trial.
8. Patients on a statin can be enrolled if they are on a stable regimen for at least 3 months before Screening, and expected to be held stable during the trial.
9. Is not pregnant and must have a negative serum pregnancy test result prior to randomization.
10. Is of non-childbearing potential or if a fertile man or woman participating in heterosexual relations, agrees to use two acceptable means of contraception (ie, 2 effective methods of contraception, one of which must be a physical barrier method \[eg, male or female condom, diaphragm\] when combined with a highly effective method of contraception \[ie, a method with a failure rate of \<1% per year when used consistently and correctly\]) throughout his/her participation in this study and for 90 days after discontinuation of study treatment.

Highly effective forms of contraception include:
* combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (such as oral, intravaginal, transdermal) methods
* progestogen-only hormonal contraception associated with inhibition of ovulation (such as oral, injectable, implantable)
* hormone-releasing intrauterine system (IUS)
* intrauterine device (IUD)
* bilateral tubal occlusion
* a vasectomized partner, provided that partner is the sole sexual partner of the women of childbearing potential trial participant and that the vasectomized partner has received medical assessment of the surgical success
* sexual abstinence (ie, a refraining from heterosexual intercourse during the entire period of the clinical trial, if it is the preferred and usual lifestyle of the subject).

Surgically sterile males and females are not required to use contraception provided they have been considered surgically sterile for at least 6 months. Surgical sterility includes history of surgically successful vasectomy, hysterectomy, or bilateral salpingo-oophorectomy. Postmenopausal women who have been amenorrheic for at least 2 years at the time of Screening will be considered sterile.
11. If a lactating woman, agrees to discontinue nursing before the start of study treatment and refrain from nursing until 90 days after the last dose of study treatment.
12. If a man, agrees to refrain from sperm donation throughout the study period and for a period of 90 days following the last dose of investigational medicinal product (IMP). Female subjects may not begin a cycle of ova donation or harvest throughout the study period and for a period of 90 days following the last dose of IMP.

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the study:

1. Presence of esophageal, gastroesophageal, or isolated gastric varices, based on an upper gastrointestinal (GI) esophagogastroduodenoscopy (EGD) exam conducted during Screening. Patients with portal hypertensive gastropathy could be enrolled.
2. History of hepatic cirrhosis decompensation including any episode of variceal bleeding, ascites not controlled by medication, spontaneous bacterial peritonitis or overt hepatic encephalopathy (West Haven grade ≥2 as assessed by the principal investigator), OR develops signs of hepatic cirrhosis decompensation during Screening.
3. Known or suspected abuse of alcohol (\>20 g/day for women or \>30 g/day for men \[on average per day\]), as per medical history. Significant alcohol consumption is defined as more than 20 grams per day in females and more than 30 grams per day in males. On average, a standard drink in the United States is considered to be 14 grams of alcohol, equivalent to 12 fluid ounces of regular beer (5% alcohol), 5 fluid ounces of table wine (12% alcohol), or 1.5 fluid ounces of 80 proof spirits (40% alcohol).
4. Alcohol dependence (ie, a score \>8 on the Alcohol Use Disorders Identification Test)
5. Narcotics or any other drug abuse or dependence in the last 5 years
6. Prior trans-jugular intrahepatic portal-systemic (TIPS) shunt procedure
7. Documented causes of liver disease other than NASH, including but not restricted to:

* Viral hepatitis, unless eradicated at least 3 years prior to Screening

* acute hepatitis A infection (presence of hepatitis A immunoglobulin M \[IgM\] at Screening)
* positive hepatitis B surface antigen
* positive hepatitis C virus (HCV) ribonucleic acid (to be performed prior to randomization in case of positive HCV antibody)
* Documented drug-induced liver disease
* Alcoholic liver disease
* Autoimmune hepatitis
* Wilson's disease
* Hemochromatosis
* Primary biliary cholangitis
* Primary sclerosing cholangitis
* Genetic hemochromatosis
* History or planned liver transplantation
* Alpha-1 antitrypsin deficiency
8. History of human immunodeficiency virus (HIV), or positive HIV test at Screening
9. Any of the following test or score:

* serum alanine aminotransferase (ALT) \> 5 × upper limit of normal (ULN)\*
* serum aspartate aminotransferase (AST) \> 5 × ULN\*

\*Screening values will be obtained at Screening Visit 1 (SV1) and Screening Visit 2(SV2) (which will be separated by 2 to 4 weeks). A second screening value that is \>50% higher than the first value should prompt re-evaluation of the severity of the underlying liver disease and eligibility for this trial. If a transaminase level at SV2 is \>33% different from the level at SV1, then additional measurements should be performed at Screening Visit 3 (SV3). In such cases, the baseline transaminase levels will be established for subjects using the mean value of 4 evaluations \[ie, at SV1, SV2, SV3, and Baseline (ie, pre-dose during Visit 1)\].
* serum alkaline phosphatase (ALP) \> 2 × ULN
* mean platelet count \< 50,000/mm3
* total bilirubin ≥ 2.0 mg/dL (subjects with a documented history of Gilbert's syndrome can be enrolled if the direct bilirubin is within normal reference range)
* model for end-stage liver disease (MELD) score ≥12
* Child-Turcotte-Pugh (CTP) Score ≥7 Note: Following Phase 2b, subjects with CTP scores ≥7 may be enrolled if recommended\* by the Data Safety Monitoring Board (DSMB) and approved by the Trial Steering Committee (TSC), based on the planned interim analysis (IA). \[\*based on DSMB review of preliminary results from a separate hepatic impairment clinical trial (Study GT-032) which is assessing belapectin safety and pharmacokinetic (PK) in cirrhotic subjects with CTP scores ≥7.
* estimated glomerular filtration rate \< 45 mL/min\* \*Note: per Modification of Diet in Renal Disease algorithm
10. Taking an angiotensin converting enzyme inhibitor, angiotensin II receptor blocker, or β-1 selective adrenergic receptor inhibitor, unless on a stable regimen for at least 3 months prior to Screening and no changes in the regimen are anticipated during the study. Subjects taking a non-selective beta blocker are not eligible to be enrolled (Investigators are encouraged to substitute another medication, if clinically warranted).
11. History of major surgery during Screening.
12. History of a solid organ transplant requiring immunosuppressive therapy.
13. History of bariatric surgery within 1 year of randomization, or plan to undergo bariatric surgery during the study.
14. Has positive screening test for illicit drugs of abuse at Screening.
15. Has participated in an investigational new drug study within 30 days or 5 half-lives whichever is longer, prior to randomization.
16. Has a history of malignancy within 5 years of randomization, except for basal cell carcinoma, squamous cell carcinoma, and adequately treated in situ uterine cervical cancer.
17. Has clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring intervention (eg, pacemaker/ablation) or Grade II or greater peripheral vascular disease.
18. Has a history of clinically significant hematologic, renal, hepatic, pulmonary, neurological, psychiatric, gastrointestinal, systemic inflammatory, metabolic or endocrine disorder or any other condition that, in the opinion of the Investigator, renders the subject a poor candidate for inclusion into the study.
19. Has known allergies to the IMP or any of its excipients.
20. Has previously received belapectin within 6 months of randomization.
21. Is an employee or family member of the Investigator or study center personnel.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galectin Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khurram Jamil, M.D.

Role: STUDY_DIRECTOR

Galectin Therapeutics Inc.

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Digestive Health Specialists

Dothan, Alabama, United States

Site Status

The Institute for Liver Health

Chandler, Arizona, United States

Site Status

Arizona Liver Health - Glendale

Glendale, Arizona, United States

Site Status

Institute for Liver Health - Tucson

Tucson, Arizona, United States

Site Status

Liver Wellness Center - Little Rock

Little Rock, Arkansas, United States

Site Status

Hope Clinical Research, Inc.

Canoga Park, California, United States

Site Status

Southern California GI & Liver Centers

Coronado, California, United States

Site Status

University of California San Diego Medical Center -La Jolla Multi-Specialty Clinics- Perlman Offices

La Jolla, California, United States

Site Status

Om Research LLC

Lancaster, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

inSite Digestive Health Care - Orange

Orange, California, United States

Site Status

California Liver Research Institute

Pasadena, California, United States

Site Status

Inland Empire Liver Foundation

Rialto, California, United States

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Site Status

Integrity Clinical Research, LLC (ICR SITES) - Doral

Doral, Florida, United States

Site Status

Nature Coast Clinical Research, LLC

Inverness, Florida, United States

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Mayo Clinic Hospital - Florida

Jacksonville, Florida, United States

Site Status

Florida Research Institute

Lakewood Rch, Florida, United States

Site Status

ClinCloud LLC

Maitland, Florida, United States

Site Status

Advanced Pharma CR, LLC

Miami, Florida, United States

Site Status

Genoma Research Group, Inc.

Miami, Florida, United States

Site Status

Sensible Healthcare

Ocoee, Florida, United States

Site Status

Guardian Angel Health Services, Inc.

Tampa, Florida, United States

Site Status

Florida Medical Center & Research

Zephyrhills, Florida, United States

Site Status

Digestive Healthcare of Georgia, P.C.

Atlanta, Georgia, United States

Site Status

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, United States

Site Status

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, United States

Site Status

Loyola University Health System

Maywood, Illinois, United States

Site Status

IU Health University Hospital

Indianapolis, Indiana, United States

Site Status

Michiana Gastroenterology, Inc.

South Bend, Indiana, United States

Site Status

Kansas Medical Clinic PA

Topeka, Kansas, United States

Site Status

University of Louisville Physicians - Cardiovascular Medicine Physicians Outpatient Center

Louisville, Kentucky, United States

Site Status

Tandem Clinical Research, LLC

Marrero, Louisiana, United States

Site Status

Tulane Cancer Center

New Orleans, Louisiana, United States

Site Status

Mercy Medical Center - The Institute for Digestive Health and Liver Disease

Baltimore, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Henry Ford Health System - Hemophilia and Thrombosis Treatment Center

Detroit, Michigan, United States

Site Status

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, United States

Site Status

Southern Therapy and Advanced Research (STAR) - Jackson

Jackson, Mississippi, United States

Site Status

Kansas City Research Institute

Kansas City, Missouri, United States

Site Status

Excel Clinical Research - Las Vegas

Las Vegas, Nevada, United States

Site Status

Mount Sinai Beth Israel

New York, New York, United States

Site Status

NYU Langone Medical Center

New York, New York, United States

Site Status

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

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Columbia University Medical Center

New York, New York, United States

Site Status

UNC-Chapel Hill School of Medicine

Chapel Hill, North Carolina, United States

Site Status

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Site Status

Lucas Research

Morehead City, North Carolina, United States

Site Status

Consultants for Clinical Research

Cincinnati, Ohio, United States

Site Status

University of Cincinnati Physicians Company, LLC

Cincinnati, Ohio, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

The Jefferson Digestive Health Institute - Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Site Status

Galen Medical Group - Ziegler Plaza

Chattanooga, Tennessee, United States

Site Status

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, United States

Site Status

Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park

Germantown, Tennessee, United States

Site Status

Associates in Gastroenterology

Hermitage, Tennessee, United States

Site Status

East Tennessee Research Institute - Gastrointestinal Associates of Northeast Tennessee, P.C.

Johnson City, Tennessee, United States

Site Status

Texas Clinical Research Institute, LLC

Arlington, Texas, United States

Site Status

Liver Specialists of Texas

Austin, Texas, United States

Site Status

Methodist Transplant Physicians

Dallas, Texas, United States

Site Status

Texoma Liver Center PLLC. - Denison

Denison, Texas, United States

Site Status

South Texas Research Institute

Edinburg, Texas, United States

Site Status

Baylor College of Medicine - Baylor Clinic - Abdominal Transplant & Liver Disease Clinic

Houston, Texas, United States

Site Status

Pioneer Research Solutions Inc - Houston - Stancliff Rd

Houston, Texas, United States

Site Status

The Texas Liver Institute, Inc.

San Antonio, Texas, United States

Site Status

Pinnacle Clinical Research

San Antonio, Texas, United States

Site Status

Impact Research Institute

Waco, Texas, United States

Site Status

University of Utah Health Care - UUHC - Kidney & Liver Clinic

Salt Lake City, Utah, United States

Site Status

University of Virginia School of Medicine

Charlottesville, Virginia, United States

Site Status

Gastroenterology Associates of Fredericksburg

Fredericksburg, Virginia, United States

Site Status

Bon Secours Liver Institute of Virginia - Newport News

Newport News, Virginia, United States

Site Status

Bon Secours Liver Institute of Virginia - Richmond

Richmond, Virginia, United States

Site Status

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Site Status

Velocity Clinical Research, Spokane

Spokane, Washington, United States

Site Status

Hospital Italiano de Buenos Aires

Buenos Aires, ARG, Argentina

Site Status

Hospital Británico de Buenos Aires

Buenos Aires, ARG, Argentina

Site Status

Centro de Investigaciones Metabólicas (CINME)

Capital Federal, ARG, Argentina

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Nepean Hospital

Kingswood, New South Wales, Australia

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Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Box Hill Hospital

Box Hill, Victoria, Australia

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Monash Medical Centre Clayton

Clayton, Victoria, Australia

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Fiona Stanley Hospital

Murdoch, Western Australia, Australia

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Antwerp University Hospital

Edegem, Antwerpen, Belgium

Site Status

Clinique Universitaire De Bruxelles Hôpital Erasme VZW

Brussels, BEL, Belgium

Site Status

AZ Maria Middelares

Ghent, VOV, Belgium

Site Status

Universitair Ziekenhuis Gent

Ghent, VOV, Belgium

Site Status

Groupe sante CHC - Clinique du MontLegia

Liège, WLG, Belgium

Site Status

University of Calgary - Heritage Medical Research Clinic - Foothills Hospital Center

Calgary, Alberta, Canada

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Pacific Gastroenterology Associates

Vancouver, British Columbia, Canada

Site Status

Brampton Civic Hospital

Brampton, Ontario, Canada

Site Status

Toronto Liver Centre

Toronto, Ontario, Canada

Site Status

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status

Hospital de La Serena

La Serena, CHL, Chile

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Clínica Universidad de los Andes

Santiago, CHL, Chile

Site Status

Centro de Investigaciones Clinicas Vina del Mar

Viña del Mar, CHL, Chile

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Hospital Clínico Universidad de Chile

Santiago, , Chile

Site Status

Centre Hospitalier Universitaire d'Amiens

Amiens, , France

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Hôpital Avicenne

Bobigny, , France

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CHU Hôpital Henri Mondor

Créteil, , France

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CHU de Grenoble

Grenoble, , France

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Hôpital de la Croix-Rousse

Lyon, , France

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CHRU Montpellier - Saint Eloi

Montpellier, , France

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CHU Nancy - Hôpital Brabois

Nancy, , France

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CHU de Nice - L'Archet

Nice, , France

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Hôpital Cochin

Paris, , France

Site Status

Hôpitaux Universitaires de Strasbourg - Hôpital Civil

Strasbourg, , France

Site Status

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status

EUGASTRO GmbH

Leipzig, Saxony, Germany

Site Status

Goethe-Universität Frankfurt am Main

Frankfurt am Main, , Germany

Site Status

Soroka Medical Center

Beersheba, , Israel

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Rambam Medical Center

Haifa, , Israel

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Carmel Medical Center

Haifa, , Israel

Site Status

Hadassah Ein Karem Hospital

Jerusalem, , Israel

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Holy Family Hospital

Nazareth, , Israel

Site Status

Rabin Medical Center - Beilinson Hospital

Petah Tikva, , Israel

Site Status

The Chaim Sheba Medical Center - The Center for Liver Diseases

Ramat Gan, , Israel

Site Status

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

CICPA Centro de Investigación Clinica del Pacifico

Acapulco de Juárez, Guerrero, Mexico

Site Status

Centro de Investigacion Medico Biologica y Terapia Avanzada SC

Guadalajara, Jalisco, Mexico

Site Status

Investigacion Biomedica para el desarrollo de farmacos SA de CV

Zapopan, Jalisco, Mexico

Site Status

Investigacion Biomedica para el desarrollo de farmacos SA de CV

Benito Juárez, Mexico City, Mexico

Site Status

CEMDEC SA de CV Centro Mexicano de Desarrollo de Estudios Clinicos

Cuauhtémoc, Mexico City, Mexico

Site Status

Centro Especializado en Diabetes, Obesidad y Pevencion de enfermedades Cadiovasculares SC.

Miguel Hidalgo, Mexico City, Mexico

Site Status

Hospital Universitario Dr. Jose Eleuterio Gonzalez Servicio de Gastroenterología

Monterrey, Nuevo León, Mexico

Site Status

Oaxaca Site Management Organization SC.

Oaxaca City, Oaxaca, Mexico

Site Status

Consultorio Medico

Ciudad de Mexico, State of Mexico, Mexico

Site Status

Medical Care and Research SA de CV

Mérida, Yucatán, Mexico

Site Status

Centro de Investigación Medica de Aguascalientes

Aguascalientes, , Mexico

Site Status

MEDIVEST Centro de Investigacion integral

Chihuahua City, , Mexico

Site Status

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, , Mexico

Site Status

SP CSK im Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach

Katowice, Silesian Voivodeship, Poland

Site Status

ID Clinic

Mysłowice, Silesian Voivodeship, Poland

Site Status

Medyczny Katedra i Klinika Chorób Zakaźnych, Chorób Wątroby i Nabytych Niedoborów Odpornościowych

Wroclaw, , Poland

Site Status

Medical University of Lodz

Lodz, Łódź Voivodeship, Poland

Site Status

Fundacion de Investigacion de Diego

San Juan, , Puerto Rico

Site Status

Hanyang University Seoul Hospital

Seoul, KOR, South Korea

Site Status

Yonsei University, Wonju Severance Christian Hospital

Seoul, KOR, South Korea

Site Status

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, KOR, South Korea

Site Status

Digestive Research Alliance of Michiana, LLC

Incheon, , South Korea

Site Status

Hospital Universitario 12 de Octubre

Madrid, ESP, Spain

Site Status

Hospital del Mar Research Institute

Barcelona, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, , Spain

Site Status

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, , Spain

Site Status

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status

King's College Hospital NHS Foundation Trust

London, GBR, United Kingdom

Site Status

The University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit

Nottingham, NGM, United Kingdom

Site Status

Countries

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United States Argentina Australia Belgium Canada Chile France Germany Israel Mexico Poland Puerto Rico South Korea Spain United Kingdom

Other Identifiers

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GT-031

Identifier Type: -

Identifier Source: org_study_id

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