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

• ClinicalTrials.gov Identifier: NCT04365868
• Recruitment Status: Active, not recruiting
• First Posted: April 28, 2020
• Last Update Posted: November 9, 2023
• Sponsor: Galectin Therapeutics Inc.
• Information provided by (Responsible Party): Galectin Therapeutics Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prevention of Esophageal Varices; NASH - Nonalcoholic Steatohepatitis; Cirrhosis	Drug: belapectin; Drug: Placebo	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 357 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: June 22, 2020
• Estimated Primary Completion Date: December 2024
• Estimated Study Completion Date: December 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Drug: belapectin; intravenous; Other Names: GR-MD-02; galactoarabino rhamnogalacturonate
Experimental: 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	Drug: belapectin; intravenous; Other Names: GR-MD-02; galactoarabino rhamnogalacturonate
Placebo Comparator: 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)	Drug: Placebo; intravenous

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks [18 months] of treatment compared to placebo [ Time Frame: At 78 weeks [18 months] ]
   Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks [18 months] of treatment compared to placebo

Secondary Outcome Measures :

1. Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop varices (esophageal or gastric) requiring treatment [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop varices (esophageal or gastric) requiring treatment
2. Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop variceal bleed requiring hospitalization [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop variceal bleed requiring hospitalization
3. Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop clinically significant ascites requiring hospitalization [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop clinically significant ascites requiring hospitalization
4. Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop spontaneous bacterial peritonitis [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop spontaneous bacterial peritonitis
5. 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) [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization)
6. Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop mortality (all-cause) [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop mortality (all-cause)
7. Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop liver transplant [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop liver transplant
8. 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 [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop model for end-stage liver disease (MELD) score ≥15
9. 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. [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   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
10. Efficacy: Event-free survival by time to first cirrhosis related clinical event, progression to large varices or red wales [ Time Frame: Through study end, 78 weeks or 156 weeks ]
    Event-free survival by time to first cirrhosis related clinical event, progression to large varices or red wales
11. Efficacy: Event-free survival by time to first cirrhosis related clinical event, esophageal variceal hemorrhage requiring hospitalization [ Time Frame: Through study end, 78 weeks or 156 weeks ]
    Event-free survival by time to first cirrhosis related clinical event, esophageal variceal hemorrhage requiring hospitalization
12. Efficacy: Event-free survival by time to first cirrhosis related clinical event, clinically significant ascites requiring hospitalization [ Time Frame: Through study end, 78 weeks or 156 weeks ]
    Event-free survival by time to first cirrhosis related clinical event, clinically significant ascites requiring hospitalization
13. Efficacy: Event-free survival by time to first cirrhosis related clinical event, spontaneous bacterial peritonitis [ Time Frame: Through study end, 78 weeks or 156 weeks ]
    Event-free survival by time to first cirrhosis related clinical event, spontaneous bacterial peritonitis
14. Efficacy: Event-free survival by time to first cirrhosis related clinical event, overt hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization) [ Time Frame: Through study end, 78 weeks or 156 weeks ]
    Event-free survival by time to first cirrhosis related clinical event, overt hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization)
15. Efficacy: Event-free survival by time to first cirrhosis related clinical event, Child-Turcotte-Pugh (CTP) score increase of ≥2 points (from baseline) [ Time Frame: Through study end, 78 weeks or 156 weeks ]
    Event-free survival by time to first cirrhosis related clinical event, Child-Turcotte-Pugh (CTP) score increase of ≥2 points (from baseline)
16. 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 [ Time Frame: Through study end, 78 weeks or 156 weeks ]
    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
17. Efficacy: Event-free survival by time to first cirrhosis related clinical event, liver transplant [ Time Frame: Through study end, 78 weeks or 156 weeks ]
    Event-free survival by time to first cirrhosis related clinical event, liver transplant
18. Efficacy: Event-free survival by time to first cirrhosis related clinical event, liver-related death [ Time Frame: Through study end, 78 weeks or 156 weeks ]
    Event-free survival by time to first cirrhosis related clinical event, liver-related death

Other Outcome Measures:

1. 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 [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   Change in liver stiffness measurement (LSM), baseline-adjusted, as determined by vibration controlled transient elastography (VCTE) (FibroScan) exams during Phase 2b and Phase 3
2. Exploratory Efficacy: Difference in Chronic Liver Disease Questionnaire (CLDQ) scores between belapectin and placebo treatment during Phase 2b and Phase 3 [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   The difference in Chronic Liver Disease Questionnaire scores between belapectin and placebo treatment during Phase 2b and Phase 3 will be observed; Subject responses to the questionnaire are based on a scale from 1 to 7, with 1 being maximum frequency and 7 being none at all. Scores indicative of higher frequency, indicate worse outcomes.
3. Safety: Incidence of adverse events [ Time Frame: Through study end, 78 weeks or 156 weeks ]
   Incidence of adverse events

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Digestive Health Specialists

Dothan, Alabama, United States, 36305

United States, Arizona

The Institute for Liver Health

Chandler, Arizona, United States, 85224

Arizona Liver Health - Glendale

Glendale, Arizona, United States, 85306

Institute for Liver Health - Tucson

Tucson, Arizona, United States, 85712

United States, Arkansas

Liver Wellness Center - Little Rock

Little Rock, Arkansas, United States, 72205-6414

United States, California

Hope Clinical Research, Inc.

Canoga Park, California, United States, 91303

Southern California GI & Liver Centers

Coronado, California, United States, 92118

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

La Jolla, California, United States, 92037

Om Research LLC

Lancaster, California, United States, 93534

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

inSite Digestive Health Care - Orange

Orange, California, United States, 92868

California Liver Research Institute

Pasadena, California, United States, 91105

Inland Empire Liver Foundation

Rialto, California, United States, 92377

United States, Colorado

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States, 80907-6262

United States, Florida

Integrity Clinical Research, LLC (ICR SITES) - Doral

Doral, Florida, United States, 33166

Nature Coast Clinical Research, LLC

Inverness, Florida, United States, 34452

Mayo Clinic Hospital - Florida

Jacksonville, Florida, United States, 32224-1865

Florida Research Institute

Lakewood Ranch, Florida, United States, 34211

ClinCloud LLC

Maitland, Florida, United States, 32751-3320

Advanced Pharma CR, LLC

Miami, Florida, United States, 33147

Genoma Research Group, Inc.

Miami, Florida, United States, 33165

Sensible Healthcare

Ocoee, Florida, United States, 34761

Guardian Angel Health Services, Inc.

Tampa, Florida, United States, 33614

Florida Medical Center & Research

Zephyrhills, Florida, United States, 33542

United States, Georgia

Digestive Healthcare of Georgia, P.C.

Atlanta, Georgia, United States, 30309

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, United States, 31201

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, United States, 30060

United States, Illinois

Loyola University Health System

Maywood, Illinois, United States, 60153

United States, Indiana

IU Health University Hospital

Indianapolis, Indiana, United States, 46202

Michiana Gastroenterology, Inc.

South Bend, Indiana, United States, 46635

United States, Kansas

Kansas Medical Clinic PA

Topeka, Kansas, United States, 66606

United States, Kentucky

University of Louisville Physicians - Cardiovascular Medicine Physicians Outpatient Center

Louisville, Kentucky, United States, 40202-2046

United States, Louisiana

Tandem Clinical Research, LLC

Marrero, Louisiana, United States, 70072

Tulane Cancer Center

New Orleans, Louisiana, United States, 70112-2600

United States, Maryland

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

Baltimore, Maryland, United States, 21202

United States, Massachusetts

Tufts Medical Center

Boston, Massachusetts, United States, 02111-1552

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Henry Ford Health System - Hemophilia and Thrombosis Treatment Center

Detroit, Michigan, United States, 48202

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, United States, 49519

United States, Mississippi

Southern Therapy and Advanced Research (STAR) - Jackson

Jackson, Mississippi, United States, 39216

United States, Missouri

Kansas City Research Institute

Kansas City, Missouri, United States, 64131

United States, Nevada

Excel Clinical Research - Las Vegas

Las Vegas, Nevada, United States, 89109-6209

United States, New York

Mount Sinai Beth Israel

New York, New York, United States, 10003

NYU Langone Medical Center

New York, New York, United States, 10016-6402

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States, 10021

Columbia University Medical Center

New York, New York, United States, 10032

United States, North Carolina

UNC-Chapel Hill School of Medicine

Chapel Hill, North Carolina, United States, 273302

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States, 28304-3571

Lucas Research

Morehead City, North Carolina, United States, 28557

United States, Ohio

Consultants for Clinical Research

Cincinnati, Ohio, United States, 45249

University of Cincinnati Physicians Company, LLC

Cincinnati, Ohio, United States, 45267-0595

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44016

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

United States, Pennsylvania

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

The Jefferson Digestive Health Institute - Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

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

Pittsburgh, Pennsylvania, United States, 15213

United States, South Carolina

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States, 29425

United States, Tennessee

Galen Medical Group - Ziegler Plaza

Chattanooga, Tennessee, United States, 37343-5470

University Diabetes & Endocrine Consultants

Chattanooga, Tennessee, United States, 37411

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

Germantown, Tennessee, United States, 38138

Associates in Gastroenterology

Hermitage, Tennessee, United States, 37067

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

Johnson City, Tennessee, United States, 37604-6063

United States, Texas

Texas Clinical Research Institute, LLC

Arlington, Texas, United States, 76012

Liver Specialists of Texas

Austin, Texas, United States, 78757

Methodist Transplant Physicians

Dallas, Texas, United States, 75203

Texoma Liver Center PLLC. - Denison

Denison, Texas, United States, 75020

South Texas Research Institute

Edinburg, Texas, United States, 78539

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

Houston, Texas, United States, 77030

Pioneer Research Solutions Inc - Houston - Stancliff Rd

Houston, Texas, United States, 77099

The Texas Liver Institute, Inc.

San Antonio, Texas, United States, 78215

Pinnacle Clinical Research

San Antonio, Texas, United States, 78229

Impact Research Institute

Waco, Texas, United States, 76710-2582

United States, Utah

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

Salt Lake City, Utah, United States, 84132-0001

United States, Virginia

University of Virginia School of Medicine

Charlottesville, Virginia, United States, 22908

Gastroenterology Associates of Fredericksburg

Fredericksburg, Virginia, United States, 22401-8425

Bon Secours Liver Institute of Virginia - Newport News

Newport News, Virginia, United States, 23602

Bon Secours Liver Institute of Virginia - Richmond

Richmond, Virginia, United States, 23226

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States, 23249-0001

United States, Washington

Velocity Clinical Research, Spokane

Spokane, Washington, United States, 99202-3462

Argentina

Hospital Británico de Buenos Aires

Buenos Aires, ARG, Argentina, C1280AEB

Centro de Investigaciones Metabólicas (CINME)

Capital federal, ARG, Argentina, C1056ABJ

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos aires, ARG, Argentina, C1181ACH

Australia, New South Wales

Nepean Hospital

Kingswood, New South Wales, Australia, 2750

Australia, South Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia, 5000

Australia, Victoria

Box Hill Hospital

Box Hill, Victoria, Australia, 3128

Monash Medical Centre Clayton

Clayton, Victoria, Australia, 3168

Australia, Western Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia, 6150

Belgium

Antwerp University Hospital

Edegem, Antwerpen, Belgium, 2650

Clinique Universitaire De Bruxelles Hôpital Erasme VZW

Brussels, BEL, Belgium, 1070

AZ Maria Middelares

Gent, VOV, Belgium, 9000

Universitair Ziekenhuis Gent

Gent, VOV, Belgium, 9000

Groupe sante CHC - Clinique du MontLegia

Liège, WLG, Belgium, 4000

Canada, Alberta

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

Calgary, Alberta, Canada, T2N 4Z6

Canada, British Columbia

Pacific Gastroenterology Associates

Vancouver, British Columbia, Canada, V6Z 2K5

Canada, Ontario

Brampton Civic Hospital

Brampton, Ontario, Canada, L6R 3J7

Toronto Liver Centre

Toronto, Ontario, Canada, M6H 3M1

Canada, Quebec

Centre Hospitalier de l'Université de Montréal (CHUM)

Montréal, Quebec, Canada, H2X 0A9

Chile

Hospital de La Serena

La Serena, CHL, Chile, 1710216

Clínica Universidad de los Andes

Santiago, CHL, Chile, 7550000

Centro de Investigaciones Clinicas Vina del Mar

Viña Del Mar, CHL, Chile, 07081-2221

Hospital Clínico Universidad de Chile

Santiago, Chile, 8380000

France

Centre Hospitalier Universitaire d'Amiens

Amiens, France, 80054

Hôpital Avicenne

Bobigny, France, 93000

CHU Hôpital Henri Mondor

Créteil, France, 94000

CHU de Grenoble

Grenoble, France, 38043

Hôpital de la Croix-Rousse

Lyon, France, 69004

CHRU Montpellier - Saint Eloi

Montpellier, France, 34090

CHU Nancy - Hôpital Brabois

Nancy, France, 54511

CHU de Nice - L'Archet

Nice, France, 6202

Hôpital Cochin

Paris, France, 75014

Hôpitaux Universitaires de Strasbourg - Hôpital Civil

Strasbourg, France, 67091

Germany

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, RP, Germany, 55131

EUGASTRO GmbH

Leipzig, SN, Germany, 4103

Goethe-Universität Frankfurt am Main

Frankfurt am Main, Germany, 60590

Israel

Soroka Medical Center

Be'er Sheva, Israel, 84101

Rambam Medical Center

Haifa, Israel, 3109601

Carmel Medical Center

Haifa, Israel, 34362

Hadassah Ein Karem Hospital

Jerusalem, Israel, 91120

Holy Family Hospital

Nazareth, Israel, 16100

Rabin Medical Center - Beilinson Hospital

Petah Tiqwa, Israel, 4941492

The Chaim Sheba Medical Center - The Center for Liver Diseases

Ramat Gan, Israel, 52621

Tel Aviv Sourasky Medical Center

Tel-Aviv, Israel, 64239

Korea, Republic of

Hanyang University Seoul Hospital

Seoul, KOR, Korea, Republic of, 4763

Yonsei University, Wonju Severance Christian Hospital

Seoul, KOR, Korea, Republic of, 8308

Yonsei University, Wonju Severance Christian Hospital

Wŏnju, KOR, Korea, Republic of, 26426

Digestive Research Alliance of Michiana, LLC

Incheon, Korea, Republic of, 400-711

Mexico

CEMDEC SA de CV Centro Mexicano de Desarrollo de Estudios Clinicos

Cuauhtémoc, Ciudad De Mexico, Mexico, 06100

Investigacion Biomedica para el desarrollo de farmacos SA de CV

Benito Juarez, Ciudad De México, Mexico, 03103

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

Miguel Hidalgo, Ciudad De México, Mexico, 11650

CICPA Centro de Investigación Clinica del Pacifico

Acapulco de Juárez, Guerrero, Mexico, 39670

Centro de Investigacion Medico Biologica y Terapia Avanzada SC

Guadalajara, Jalisco, Mexico, 44130

Investigacion Biomedica para el desarrollo de farmacos SA de CV

Zapopan, Jalisco, Mexico, 45070

Consultorio Medico

Ciudad De Mexico, MEX, Mexico, 6700

Hospital Universitario Dr. Jose Eleuterio Gonzalez Servicio de Gastroenterología

Monterrey, Nuevo Leon, Mexico, 64460

Oaxaca Site Management Organization SC.

Oaxaca de Juarez, Oaxaca, Mexico, 68000

Medical Care and Research SA de CV

Mérida, Yucatan, Mexico, 97070

Centro de Investigación Medica de Aguascalientes

Aguascalientes, Mexico, 20116

MEDIVEST Centro de Investigacion integral

Chihuahua, Mexico, 31203

Centro de Investigacion Clinica de Oaxaca

Oaxaca, Mexico, 68020

Poland

Medical University of Lodz

Łódź, LD, Poland, 91-347

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

Katowice, SL, Poland, 40-752

ID Clinic

Mysłowice, SL, Poland, 41-400

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

Wrocław, Poland, 50-220

Puerto Rico

Fundacion de Investigacion de Diego

San Juan, Puerto Rico, 00927

Spain

Hospital Universitario 12 de Octubre

Madrid, ESP, Spain, 28041

Hospital del Mar Research Institute

Barcelona, Spain, 8003

Hospital Universitario Ramón y Cajal

Madrid, Spain, 28034

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Spain, 28222

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, Spain, 36071

Hospital Universitario Marqués de Valdecilla

Santander, Spain, 39008

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

United Kingdom

King's College Hospital NHS Foundation Trust

London, GBR, United Kingdom, SE5 9RS

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

Nottingham, NGM, United Kingdom, NG7 2UH

Sponsors and Collaborators

Galectin Therapeutics Inc.

Investigators

• Study Director: Pol Boudes, M.D.; Galectin Therapeutics Inc.

More Information

• Responsible Party: Galectin Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT04365868
• Other Study ID Numbers: GT-031
• First Posted: April 28, 2020
• Last Update Posted: November 9, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Galectin Therapeutics Inc.:

esophageal varices; belapectin; GR-MD-02; portal hypertension; nonalcoholic steatohepatitis (NASH) cirrhosis; NASH; cirrhosis

Additional relevant MeSH terms:

Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease; Esophageal and Gastric Varices; Varicose Veins; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Hypertension, Portal