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Prevention of Esophageal VaricesPhase 2/3NAVIGATENCT04365868

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

A Phase 2/3 study testing belapectin in people with Prevention of Esophageal Varices and NASH - Nonalcoholic Steatohepatitis, run by Galectin Therapeutics Inc. at 156 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
belapectin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
357 participants
Where
156 sitesin 15 countries
Study dates
25 Jun 2020to 10 Apr 2025
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each subject must meet all of the following criteria to be enrolled in this study:
  • Is male or female, ≥ 18 and ≤ 75 years of age at the time of Screening.
  • Is willing and able to provide written informed consent prior to the initiation of any study-specific procedures.
  • Has evidence of portal hypertension, with either one of the following:
  • platelet count <150,000/mm3
  • OR
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  • documented hepatic venous pressure gradient (HVPG) measurement >6 mmHg
  • OR
  • 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.
  • 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.
  • 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.
  • 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%.
  • 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.
  • 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.
  • Is not pregnant and must have a negative serum pregnancy test result prior to randomization.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Subjects meeting any of the following criteria will be excluded from the study:
  • 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.
  • 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.
  • 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).
  • Alcohol dependence (ie, a score >8 on the Alcohol Use Disorders Identification Test)
  • Narcotics or any other drug abuse or dependence in the last 5 years
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  • Prior trans-jugular intrahepatic portal-systemic (TIPS) shunt procedure
  • 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
  • History of human immunodeficiency virus (HIV), or positive HIV test at Screening
  • 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
  • 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).
  • History of major surgery during Screening.
  • History of a solid organ transplant requiring immunosuppressive therapy.
  • History of bariatric surgery within 1 year of randomization, or plan to undergo bariatric surgery during the study.
  • Has positive screening test for illicit drugs of abuse at Screening.
  • Has participated in an investigational new drug study within 30 days or 5 half-lives whichever is longer, prior to randomization.
  • 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.
  • 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.
  • 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.
  • Has known allergies to the IMP or any of its excipients.
  • Has previously received belapectin within 6 months of randomization.
  • Is an employee or family member of the Investigator or study center personnel.

Trial locations and contacts

156 sites in 15 countries.

156 sites in 15 countries

United States81 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Digestive Healthcare of Georgia, P.C.

    Atlanta, Georgia, 30309

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Liver Specialists of Texas

    Austin, Texas, 78757

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

    Baltimore, Maryland, 21202

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111-1552

  • Hope Clinical Research, Inc.

    Canoga Park, California, 91303

  • The Institute for Liver Health

    Chandler, Arizona, 85224

  • UNC-Chapel Hill School of Medicine

    Chapel Hill, North Carolina, 273302

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • University of Virginia School of Medicine

    Charlottesville, Virginia, 22908

  • Galen Medical Group - Ziegler Plaza

    Chattanooga, Tennessee, 37343-5470

  • University Diabetes & Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45249

  • University of Cincinnati Physicians Company, LLC

    Cincinnati, Ohio, 45267-0595

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44016

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907-6262

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Southern California GI & Liver Centers

    Coronado, California, 92118

  • Methodist Transplant Physicians

    Dallas, Texas, 75203

  • Texoma Liver Center PLLC. - Denison

    Denison, Texas, 75020

  • Henry Ford Health System - Hemophilia and Thrombosis Treatment Center

    Detroit, Michigan, 48202

  • Integrity Clinical Research, LLC (ICR SITES) - Doral

    Doral, Florida, 33166

  • Digestive Health Specialists

    Dothan, Alabama, 36305

  • South Texas Research Institute

    Edinburg, Texas, 78539

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304-3571

  • Gastroenterology Associates of Fredericksburg

    Fredericksburg, Virginia, 22401-8425

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

    Germantown, Tennessee, 38138

  • Arizona Liver Health - Glendale

    Glendale, Arizona, 85306

  • Associates in Gastroenterology

    Hermitage, Tennessee, 37067

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

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

    Houston, Texas, 77030

  • Pioneer Research Solutions Inc - Houston - Stancliff Rd

    Houston, Texas, 77099

  • IU Health University Hospital

    Indianapolis, Indiana, 46202

  • Nature Coast Clinical Research, LLC

    Inverness, Florida, 34452

  • Southern Therapy and Advanced Research (STAR) - Jackson

    Jackson, Mississippi, 39216

  • Mayo Clinic Hospital - Florida

    Jacksonville, Florida, 32224-1865

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

    Johnson City, Tennessee, 37604-6063

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

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

    La Jolla, California, 92037

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Om Research LLC

    Lancaster, California, 93534

  • Excel Clinical Research - Las Vegas

    Las Vegas, Nevada, 89109-6209

  • Liver Wellness Center - Little Rock

    Little Rock, Arkansas, 72205-6414

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Louisville Physicians - Cardiovascular Medicine Physicians Outpatient Center

    Louisville, Kentucky, 40202-2046

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31201

  • ClinCloud LLC

    Maitland, Florida, 32751-3320

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Tandem Clinical Research, LLC

    Marrero, Louisiana, 70072

  • Loyola University Health System

    Maywood, Illinois, 60153

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147

  • Genoma Research Group, Inc.

    Miami, Florida, 33165

  • Lucas Research

    Morehead City, North Carolina, 28557

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112-2600

  • Mount Sinai Beth Israel

    New York, New York, 10003

  • NYU Langone Medical Center

    New York, New York, 10016-6402

  • NewYork-Presbyterian Hospital/Weill Cornell Medical Center

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10032

  • Bon Secours Liver Institute of Virginia - Newport News

    Newport News, Virginia, 23602

  • Sensible Healthcare

    Ocoee, Florida, 34761

  • inSite Digestive Health Care - Orange

    Orange, California, 92868

  • California Liver Research Institute

    Pasadena, California, 91105

  • The Jefferson Digestive Health Institute - Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

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

    Pittsburgh, Pennsylvania, 15213

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • Bon Secours Liver Institute of Virginia - Richmond

    Richmond, Virginia, 23226

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249-0001

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

    Salt Lake City, Utah, 84132-0001

  • The Texas Liver Institute, Inc.

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229

  • Michiana Gastroenterology, Inc.

    South Bend, Indiana, 46635

  • Velocity Clinical Research, Spokane

    Spokane, Washington, 99202-3462

  • Guardian Angel Health Services, Inc.

    Tampa, Florida, 33614

  • Kansas Medical Clinic PA

    Topeka, Kansas, 66606

  • Institute for Liver Health - Tucson

    Tucson, Arizona, 85712

  • Impact Research Institute

    Waco, Texas, 76710-2582

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519

  • Florida Medical Center & Research

    Zephyrhills, Florida, 33542

Other trials in United States

Mexico13 sites

  • CICPA Centro de Investigación Clinica del Pacifico

    Acapulco de Juárez, Guerrero, 39670

  • Centro de Investigación Medica de Aguascalientes

    Aguascalientes, Aguascalientes, 20116

  • Investigacion Biomedica para el desarrollo de farmacos SA de CV

    Benito Juárez, Mexico City, 03103

  • MEDIVEST Centro de Investigacion integral

    Chihuahua City, Chihuahua, 31203

  • Consultorio Medico

    Ciudad de Mexico, State of Mexico, 6700

  • CEMDEC SA de CV Centro Mexicano de Desarrollo de Estudios Clinicos

    Cuauhtémoc, Mexico City, 06100

  • Centro de Investigacion Medico Biologica y Terapia Avanzada SC

    Guadalajara, Jalisco, 44130

  • Medical Care and Research SA de CV

    Mérida, Yucatán, 97070

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

    Miguel Hidalgo, Mexico City, 11650

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez Servicio de Gastroenterología

    Monterrey, Nuevo León, 64460

  • Oaxaca Site Management Organization SC.

    Oaxaca City, Oaxaca, 68000

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, Oaxaca, 68020

  • Investigacion Biomedica para el desarrollo de farmacos SA de CV

    Zapopan, Jalisco, 45070

Other trials in Mexico

France10 sites

  • 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

Other trials in France

Israel8 sites

  • Soroka Medical Center

    Beersheba, 84101

  • Rambam Medical Center

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 34362

  • Hadassah Ein Karem Hospital

    Jerusalem, 91120

  • Holy Family Hospital

    Nazareth, 16100

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center - The Center for Liver Diseases

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Spain8 sites

  • Hospital del Mar Research Institute

    Barcelona, Spain, 8003

  • Hospital Universitario 12 de Octubre

    Madrid, ESP, 28041

  • 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

    Seville, Spain, 41013

Other trials in Spain

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Monash Medical Centre Clayton

    Clayton, Victoria, 3168

  • Nepean Hospital

    Kingswood, New South Wales, 2750

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

Other trials in Australia

Belgium5 sites

  • Clinique Universitaire De Bruxelles Hôpital Erasme VZW

    Brussels, BEL, 1070

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650

  • AZ Maria Middelares

    Ghent, VOV, 9000

  • Universitair Ziekenhuis Gent

    Ghent, VOV, 9000

  • Groupe sante CHC - Clinique du MontLegia

    Liège, WLG, 4000

Other trials in Belgium

Canada5 sites

  • Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

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

    Calgary, Alberta, T2N 4Z6

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 0A9

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • Pacific Gastroenterology Associates

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

Chile4 sites

  • Hospital de La Serena

    La Serena, CHL, 1710216

  • Clínica Universidad de los Andes

    Santiago, CHL, 7550000

  • Hospital Clínico Universidad de Chile

    Santiago, 8380000

  • Centro de Investigaciones Clinicas Vina del Mar

    Viña del Mar, CHL, 07081-2221

Other trials in Chile

Poland4 sites

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

    Katowice, Silesian Voivodeship, 40-752

  • Medical University of Lodz

    Lodz, Łódź Voivodeship, 91-347

  • ID Clinic

    Mysłowice, Silesian Voivodeship, 41-400

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

    Wroclaw, Poland, 50-220

Other trials in Poland

South Korea4 sites

  • Digestive Research Alliance of Michiana, LLC

    Incheon, 400-711

  • Hanyang University Seoul Hospital

    Seoul, KOR, 4763

  • Yonsei University, Wonju Severance Christian Hospital

    Seoul, KOR, 8308

  • Yonsei University, Wonju Severance Christian Hospital

    Wŏnju, KOR, 26426

Other trials in South Korea

Argentina3 sites

  • Hospital Italiano de Buenos Aires

    Buenos Aires, ARG, C1181ACH

  • Hospital Británico de Buenos Aires

    Buenos Aires, ARG, C1280AEB

  • Centro de Investigaciones Metabólicas (CINME)

    Capital Federal, ARG, C1056ABJ

Other trials in Argentina

Germany3 sites

  • Goethe-Universität Frankfurt am Main

    Frankfurt am Main, Germany, 60590

  • EUGASTRO GmbH

    Leipzig, Saxony, 4103

  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

United Kingdom2 sites

  • King's College Hospital NHS Foundation Trust

    London, GBR, SE5 9RS

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

    Nottingham, NGM, NG7 2UH

Other trials in United Kingdom

Puerto Rico1 site

  • Fundacion de Investigacion de Diego

    San Juan, Puerto Rico, 00927

Other trials in Puerto Rico

About this study

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

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.

Being tested
belapectin, Placebo
Keywords
esophageal varices, belapectin, GR-MD-02, portal hypertension, nonalcoholic steatohepatitis (NASH) cirrhosis, NASH, cirrhosis
Medical subject headings
Non-alcoholic Fatty Liver Disease, Fibrosis, Esophageal and Gastric Varices, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • belapectinDrug

    Also called GR-MD-02, galactoarabino rhamnogalacturonate

    intravenous

  • PlaceboDrug

    intravenous

Study groups in NCT04365868
Study groupRoleWhat they receive
belapectin 2 mg/kg lean body mass (LBM)ExperimentalPhase 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
Receives: Drug: belapectin
belapectin 4 mg/kg lean body mass (LBM)ExperimentalPhase 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
Receives: Drug: belapectin
PlaceboPlacebo comparatorPhase 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)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients in the Belapectin Treatment Groups Who Develop New Esophageal Varices at 78 Weeks [18 Months] of Treatment Compared to Placebo

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

    Measured: At 78 weeks [18 months]

Secondary outcomes (18)

  1. Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Varices (Esophageal or Gastric) Requiring Treatment

    Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop varices (esophageal or gastric) requiring treatment.

    Measured: Through study end, 78 weeks or 156 weeks

  2. Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Variceal Bleed Requiring Hospitalization

    Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop variceal bleed requiring hospitalization.

    Measured: Through study end, 78 weeks or 156 weeks

  3. Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Clinically Significant Ascites Requiring Hospitalization

    Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop clinically significant ascites requiring hospitalization.

    Measured: Through study end, 78 weeks or 156 weeks

  4. Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Spontaneous Bacterial Peritonitis

    Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop spontaneous bacterial peritonitis.

    Measured: Through study end, 78 weeks or 156 weeks

  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)

    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).

    Measured: Through study end, 78 weeks or 156 weeks

  6. Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Mortality (All-cause)

    Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop mortality (all-cause).

    Measured: Through study end, 78 weeks or 156 weeks

  7. Efficacy: Cumulative Incidence Rate of Patients in the Belapectin Treatment Groups, Compared to Placebo, Who Develop Liver Transplant

    Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop liver transplant.

    Measured: Through study end, 78 weeks or 156 weeks

  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

    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.

    Measured: Through study end, 78 weeks or 156 weeks

  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.

    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.

    Measured: Through study end, 78 weeks or 156 weeks

  10. Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Progression to Large Varices or Red Wales

    Number of participants who experienced first cirrhosis related clinical event, progression to large varices or red wales by week 78.

    Measured: Through study end, 78 weeks or 156 weeks

  11. Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Esophageal Variceal Hemorrhage Requiring Hospitalization

    Number of participants who experienced first cirrhosis related clinical event, esophageal variceal hemorrhage requiring hospitalization by week 78.

    Measured: Through study end, 78 weeks or 156 weeks

  12. Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Clinically Significant Ascites Requiring Hospitalization

    Number of participants who experienced first cirrhosis related clinical event, clinically significant ascites requiring hospitalization by week 78.

    Measured: Through study end, 78 weeks or 156 weeks

  13. Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Spontaneous Bacterial Peritonitis

    Number of participants who experienced first cirrhosis related clinical event, spontaneous bacterial peritonitis by week 78.

    Measured: Through study end, 78 weeks or 156 weeks

  14. Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Overt Hepatic Encephalopathy (West Haven Score ≥2 and Requiring Hospitalization)

    Number of participants who experienced first cirrhosis related clinical event, overt hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization) by week 78.

    Measured: Through study end, 78 weeks or 156 weeks

  15. Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Child-Turcotte-Pugh (CTP) Score Increase of ≥2 Points (From Baseline)

    Number of participants who experienced first cirrhosis related clinical event, Child-Turcotte-Pugh (CTP) score increase of ≥2 points (from baseline) by week 78.

    Measured: Through study end, 78 weeks or 156 weeks

  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

    Number of participants who experienced first cirrhosis related clinical event, model for end-stage liver disease (MELD) score increase to ≥15 as measured on 2 consecutive occasions by week 78.

    Measured: Through study end, 78 weeks or 156 weeks

  17. Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Liver Transplant

    Number of participants who experienced first cirrhosis related clinical event, liver transplant by week 78.

    Measured: Through study end, 78 weeks or 156 weeks

  18. Efficacy: Event-free Survival by Time to First Cirrhosis Related Clinical Event, Liver-related Death

    Number of participants who experienced first cirrhosis related clinical event, liver-related death by week 78.

    Measured: Through study end, 78 weeks or 156 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2020
  2. Study start25 Jun 2020
  3. Primary completion11 Mar 2025
  4. Study completion10 Apr 2025

Why it stopped: Based on FDA feedback, Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was not prematurely terminated for safety reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
357 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04365868
Sponsor's protocol ID
GT-031
Acronym
NAVIGATE
Status last verified
Jun 2026
First submitted
24 Apr 2020
Last updated
30 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing belapectin in people with Prevention of Esophageal Varices and NASH - Nonalcoholic Steatohepatitis, run by Galectin Therapeutics Inc. at 156 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Mexico, France, Israel, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04365868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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