Clinical trial NCT04365868: Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
Official title: A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Prevention of Esophageal Varices
NASH - Nonalcoholic Steatohepatitis
Cirrhosis
Keywords: esophageal varices
belapectin
GR-MD-02
portal hypertension
nonalcoholic steatohepatitis (NASH) cirrhosis
NASH
cirrhosis
Lead sponsor: Galectin Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-28
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks [18 months] of treatment compared to placebo
timeFrame: At 78 weeks [18 months]
Secondary outcomes:
measure: Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop varices (esophageal or gastric) requiring treatment
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop variceal bleed requiring hospitalization
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop clinically significant ascites requiring hospitalization
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop spontaneous bacterial peritonitis
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization)
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop mortality (all-cause)
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop liver transplant
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop model for end-stage liver disease (MELD) score ≥15
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Cumulative incidence rate of patients in the belapectin Phase 3 treatment group who progress to large varices (gastric or esophageal) or develop red wales compared to placebo.
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Event-free survival by time to first cirrhosis related clinical event, progression to large varices or red wales
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Event-free survival by time to first cirrhosis related clinical event, esophageal variceal hemorrhage requiring hospitalization
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Event-free survival by time to first cirrhosis related clinical event, clinically significant ascites requiring hospitalization
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Event-free survival by time to first cirrhosis related clinical event, spontaneous bacterial peritonitis
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Event-free survival by time to first cirrhosis related clinical event, overt hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization)
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Event-free survival by time to first cirrhosis related clinical event, Child-Turcotte-Pugh (CTP) score increase of ≥2 points (from baseline)
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Event-free survival by time to first cirrhosis related clinical event, model for end-stage liver disease (MELD) score increase to ≥15 as measured on 2 consecutive occasions
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Event-free survival by time to first cirrhosis related clinical event, liver transplant
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Efficacy: Event-free survival by time to first cirrhosis related clinical event, liver-related death
timeFrame: Through study end, 78 weeks or 156 weeks
Other outcomes:
measure: Exploratory Efficacy:Change in liver stiffness measurement (LSM), baseline-adjusted, as determined by vibration controlled transient elastography (VCTE) (FibroScan) exams during Phase 2b and Phase 3
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Exploratory Efficacy: Difference in Chronic Liver Disease Questionnaire (CLDQ) scores between belapectin and placebo treatment during Phase 2b and Phase 3
timeFrame: Through study end, 78 weeks or 156 weeks
measure: Safety: Incidence of adverse events
timeFrame: Through study end, 78 weeks or 156 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Dothan
country: United States
facility: Digestive Health Specialists
state: Alabama
city: Chandler
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Glendale
country: United States
facility: Arizona Liver Health - Glendale
state: Arizona
city: Tucson
country: United States
facility: Institute for Liver Health - Tucson
state: Arizona
city: Little Rock
country: United States
facility: Liver Wellness Center - Little Rock
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Coronado
country: United States
facility: Southern California GI & Liver Centers
state: California
city: La Jolla
country: United States
facility: University of California San Diego Medical Center -La Jolla Multi-Specialty Clinics- Perlman Offices
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Orange
country: United States
facility: inSite Digestive Health Care - Orange
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Doral
country: United States
facility: Integrity Clinical Research, LLC (ICR SITES) - Doral
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Hospital - Florida
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute
state: Florida
city: Maitland
country: United States
facility: ClinCloud LLC
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Miami
country: United States
facility: Genoma Research Group, Inc.
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare
state: Florida
city: Tampa
country: United States
facility: Guardian Angel Health Services, Inc.
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Center & Research
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia, P.C.
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Maywood
country: United States
facility: Loyola University Health System
state: Illinois
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
city: South Bend
country: United States
facility: Michiana Gastroenterology, Inc.
state: Indiana
city: Topeka
country: United States
facility: Kansas Medical Clinic PA
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Physicians - Cardiovascular Medicine Physicians Outpatient Center
state: Kentucky
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Cancer Center
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center - The Institute for Digestive Health and Liver Disease
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System - Hemophilia and Thrombosis Treatment Center
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan
state: Michigan
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research (STAR) - Jackson
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Las Vegas
country: United States
facility: Excel Clinical Research - Las Vegas
state: Nevada
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian Hospital/Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill School of Medicine
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates, LLC
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company, LLC
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Jefferson Digestive Health Institute - Thomas Jefferson University
state: Pennsylvania
city: Pittsburg
country: United States
facility: University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Chattanooga
country: United States
facility: Galen Medical Group - Ziegler Plaza
state: Tennessee
city: Chattanooga
country: United States
facility: University Diabetes & Endocrine Consultants
state: Tennessee
city: Germantown
country: United States
facility: Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park
state: Tennessee
city: Hermitage
country: United States
facility: Associates in Gastroenterology
state: Tennessee
city: Johnson City
country: United States
facility: East Tennessee Research Institute - Gastrointestinal Associates of Northeast Tennessee, P.C.
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Austin
country: United States
facility: Liver Specialists of Texas
state: Texas
city: Dallas
country: United States
facility: Methodist Transplant Physicians
state: Texas
city: Denison
country: United States
facility: Texoma Liver Center PLLC. - Denison
state: Texas
city: Edinburg
country: United States
facility: South Texas Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Baylor Clinic - Abdominal Transplant & Liver Disease Clinic
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions Inc - Houston - Stancliff Rd
state: Texas
city: San Antonio
country: United States
facility: The Texas Liver Institute, Inc.
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Waco
country: United States
facility: Impact Research Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Care - UUHC - Kidney & Liver Clinic
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia School of Medicine
state: Virginia
city: Fredericksburg
country: United States
facility: Gastroenterology Associates of Fredericksburg
state: Virginia
city: Newport News
country: United States
facility: Bon Secours Liver Institute of Virginia - Newport News
state: Virginia
city: Richmond
country: United States
facility: Bon Secours Liver Institute of Virginia - Richmond
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
city: Spokane
country: United States
facility: Velocity Clinical Research, Spokane
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires
state: ARG
city: Capital federal
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: ARG
city: Ciudad Autonoma de Buenos aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: ARG
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre Clayton
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerpen
city: Brussels
country: Belgium
facility: Clinique Universitaire De Bruxelles Hôpital Erasme VZW
state: BEL
city: Gent
country: Belgium
facility: AZ Maria Middelares
state: VOV
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: VOV
city: Liège
country: Belgium
facility: Groupe sante CHC - Clinique du MontLegia
state: WLG
city: Calgary
country: Canada
facility: University of Calgary - Heritage Medical Research Clinic - Foothills Hospital Center
state: Alberta
city: Vancouver
country: Canada
facility: Pacific Gastroenterology Associates
state: British Columbia
city: Brampton
country: Canada
facility: Brampton Civic Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: La Serena
country: Chile
facility: Hospital de La Serena
state: CHL
city: Santiago
country: Chile
facility: Clínica Universidad de los Andes
state: CHL
city: Viña Del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina del Mar
state: CHL
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Créteil
country: France
facility: CHU Hôpital Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
city: Montpellier
country: France
facility: CHRU Montpellier - Saint Eloi
city: Nancy
country: France
facility: CHU Nancy - Hôpital Brabois
city: Nice
country: France
facility: CHU de Nice - L'Archet
city: Paris
country: France
facility: Hôpital Cochin
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
state: RP
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
state: SN
city: Frankfurt am Main
country: Germany
facility: Goethe-Universität Frankfurt am Main
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital
city: Nazareth
country: Israel
facility: Holy Family Hospital
city: Petah Tiqwa
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center - The Center for Liver Diseases
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
state: KOR
city: Seoul
country: Korea, Republic of
facility: Yonsei University, Wonju Severance Christian Hospital
state: KOR
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University, Wonju Severance Christian Hospital
state: KOR
city: Incheon
country: Korea, Republic of
facility: Digestive Research Alliance of Michiana, LLC
city: Cuauhtémoc
country: Mexico
facility: CEMDEC SA de CV Centro Mexicano de Desarrollo de Estudios Clinicos
state: Ciudad de Mexico
city: Benito Juarez
country: Mexico
facility: Investigacion Biomedica para el desarrollo de farmacos SA de CV
state: Ciudad de México
city: Miguel Hidalgo
country: Mexico
facility: Centro Especializado en Diabetes, Obesidad y Pevencion de enfermedades Cadiovasculares SC.
state: Ciudad de México
city: Acapulco de Juárez
country: Mexico
facility: CICPA Centro de Investigación Clinica del Pacifico
state: Guerrero
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medico Biologica y Terapia Avanzada SC
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el desarrollo de farmacos SA de CV
state: Jalisco
city: Ciudad De Mexico
country: Mexico
facility: Consultorio Medico
state: MEX
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez Servicio de Gastroenterología
state: Nuevo Leon
city: Oaxaca de Juarez
country: Mexico
facility: Oaxaca Site Management Organization SC.
state: Oaxaca
city: Mérida
country: Mexico
facility: Medical Care and Research SA de CV
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Centro de Investigación Medica de Aguascalientes
city: Chihuahua
country: Mexico
facility: MEDIVEST Centro de Investigacion integral
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
city: Łódź
country: Poland
facility: Medical University of Lodz
state: LD
city: Katowice
country: Poland
facility: SP CSK im Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach
state: SL
city: Mysłowice
country: Poland
facility: ID Clinic
state: SL
city: Wrocław
country: Poland
facility: Medyczny Katedra i Klinika Chorób Zakaźnych, Chorób Wątroby i Nabytych Niedoborów Odpornościowych
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: ESP
city: Barcelona
country: Spain
facility: Hospital del Mar Research Institute
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Pontevedra
country: Spain
facility: Complexo Hospitalario Universitario de Pontevedra
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: GBR
city: Nottingham
country: United Kingdom
facility: The University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit
state: NGM
Study officials:
affiliation: Galectin Therapeutics Inc.
name: Khurram Jamil, M.D.
role: STUDY_DIRECTOR
References: