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

Primary Purpose

Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
belapectin
Placebo
Sponsored by
Galectin Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Esophageal Varices focused on measuring esophageal varices, belapectin, GR-MD-02, portal hypertension, nonalcoholic steatohepatitis (NASH) cirrhosis, NASH, cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Digestive Health Specialists
  • The Institute for Liver Health
  • Arizona Liver Health - Glendale
  • Institute for Liver Health - Tucson
  • Liver Wellness Center - Little Rock
  • Hope Clinical Research, Inc.
  • Southern California GI & Liver Centers
  • University of California San Diego Medical Center -La Jolla Multi-Specialty Clinics- Perlman Offices
  • Om Research LLC
  • Cedars-Sinai Medical Center
  • inSite Digestive Health Care - Orange
  • California Liver Research Institute
  • Inland Empire Liver Foundation
  • University of Colorado Anschutz Medical Campus
  • Peak Gastroenterology Associates
  • Integrity Clinical Research, LLC (ICR SITES) - Doral
  • Nature Coast Clinical Research, LLC
  • Mayo Clinic Hospital - Florida
  • Florida Research Institute
  • ClinCloud LLC
  • Advanced Pharma CR, LLC
  • Genoma Research Group, Inc.
  • Sensible Healthcare
  • Guardian Angel Health Services, Inc.
  • Florida Medical Center & Research
  • Digestive Healthcare of Georgia, P.C.
  • Gastroenterology Associates of Central Georgia, LLC
  • Gastrointestinal Specialists of Georgia, PC
  • Loyola University Health System
  • IU Health University Hospital
  • Michiana Gastroenterology, Inc.
  • Kansas Medical Clinic PA
  • University of Louisville Physicians - Cardiovascular Medicine Physicians Outpatient Center
  • Tandem Clinical Research, LLC
  • Tulane Cancer Center
  • Mercy Medical Center - The Institute for Digestive Health and Liver Disease
  • Tufts Medical Center
  • University of Michigan
  • Henry Ford Health System - Hemophilia and Thrombosis Treatment Center
  • Gastroenterology Associates of Western Michigan
  • Southern Therapy and Advanced Research (STAR) - Jackson
  • Kansas City Research Institute
  • Excel Clinical Research - Las Vegas
  • Mount Sinai Beth Israel
  • NYU Langone Medical Center
  • NewYork-Presbyterian Hospital/Weill Cornell Medical Center
  • Columbia University Medical Center
  • UNC-Chapel Hill School of Medicine
  • Cumberland Research Associates, LLC
  • Lucas Research
  • Consultants for Clinical Research
  • University of Cincinnati Physicians Company, LLC
  • University Hospitals Cleveland Medical Center
  • The Ohio State University Wexner Medical Center
  • Penn State Milton S. Hershey Medical Center
  • The Jefferson Digestive Health Institute - Thomas Jefferson University
  • University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
  • Medical University of South Carolina (MUSC)
  • Galen Medical Group - Ziegler Plaza
  • University Diabetes & Endocrine Consultants
  • Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park
  • Associates in Gastroenterology
  • East Tennessee Research Institute - Gastrointestinal Associates of Northeast Tennessee, P.C.
  • Texas Clinical Research Institute, LLC
  • Liver Specialists of Texas
  • Methodist Transplant Physicians
  • Texoma Liver Center PLLC. - Denison
  • South Texas Research Institute
  • Baylor College of Medicine - Baylor Clinic - Abdominal Transplant & Liver Disease Clinic
  • Pioneer Research Solutions Inc - Houston - Stancliff Rd
  • The Texas Liver Institute, Inc.
  • Pinnacle Clinical Research
  • Impact Research Institute
  • University of Utah Health Care - UUHC - Kidney & Liver Clinic
  • University of Virginia School of Medicine
  • Gastroenterology Associates of Fredericksburg
  • Bon Secours Liver Institute of Virginia - Newport News
  • Bon Secours Liver Institute of Virginia - Richmond
  • Hunter Holmes McGuire VA Medical Center
  • Velocity Clinical Research, Spokane
  • Hospital Británico de Buenos Aires
  • Centro de Investigaciones Metabólicas (CINME)
  • Hospital Italiano de Buenos Aires
  • Nepean Hospital
  • Royal Adelaide Hospital
  • Box Hill Hospital
  • Monash Medical Centre Clayton
  • Fiona Stanley Hospital
  • Antwerp University Hospital
  • Clinique Universitaire De Bruxelles Hôpital Erasme VZW
  • AZ Maria Middelares
  • Universitair Ziekenhuis Gent
  • Groupe sante CHC - Clinique du MontLegia
  • University of Calgary - Heritage Medical Research Clinic - Foothills Hospital Center
  • Pacific Gastroenterology Associates
  • Brampton Civic Hospital
  • Toronto Liver Centre
  • Centre Hospitalier de l'Université de Montréal (CHUM)
  • Hospital de La Serena
  • Clínica Universidad de los Andes
  • Centro de Investigaciones Clinicas Vina del Mar
  • Hospital Clínico Universidad de Chile
  • Centre Hospitalier Universitaire d'Amiens
  • Hôpital Avicenne
  • CHU Hôpital Henri Mondor
  • CHU de Grenoble
  • Hôpital de la Croix-Rousse
  • CHRU Montpellier - Saint Eloi
  • CHU Nancy - Hôpital Brabois
  • CHU de Nice - L'Archet
  • Hôpital Cochin
  • Hôpitaux Universitaires de Strasbourg - Hôpital Civil
  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
  • EUGASTRO GmbH
  • Goethe-Universität Frankfurt am Main
  • Soroka Medical Center
  • Rambam Medical Center
  • Carmel Medical Center
  • Hadassah Ein Karem Hospital
  • Holy Family Hospital
  • Rabin Medical Center - Beilinson Hospital
  • The Chaim Sheba Medical Center - The Center for Liver Diseases
  • Tel Aviv Sourasky Medical Center
  • Hanyang University Seoul Hospital
  • Yonsei University, Wonju Severance Christian Hospital
  • Yonsei University, Wonju Severance Christian Hospital
  • Digestive Research Alliance of Michiana, LLC
  • CEMDEC SA de CV Centro Mexicano de Desarrollo de Estudios Clinicos
  • Investigacion Biomedica para el desarrollo de farmacos SA de CV
  • Centro Especializado en Diabetes, Obesidad y Pevencion de enfermedades Cadiovasculares SC.
  • CICPA Centro de Investigación Clinica del Pacifico
  • Centro de Investigacion Medico Biologica y Terapia Avanzada SC
  • Investigacion Biomedica para el desarrollo de farmacos SA de CV
  • Consultorio Medico
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez Servicio de Gastroenterología
  • Oaxaca Site Management Organization SC.
  • Medical Care and Research SA de CV
  • Centro de Investigación Medica de Aguascalientes
  • MEDIVEST Centro de Investigacion integral
  • Centro de Investigacion Clinica de Oaxaca
  • Medical University of Lodz
  • SP CSK im Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach
  • ID Clinic
  • Medyczny Katedra i Klinika Chorób Zakaźnych, Chorób Wątroby i Nabytych Niedoborów Odpornościowych
  • Fundacion de Investigacion de Diego
  • Hospital Universitario 12 de Octubre
  • Hospital del Mar Research Institute
  • Hospital Universitario Ramón y Cajal
  • Hospital Universitario La Paz
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Complexo Hospitalario Universitario de Pontevedra
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Universitario Virgen del Rocío
  • King's College Hospital NHS Foundation Trust
  • The University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

belapectin 2 mg/kg lean body mass (LBM)

belapectin 4 mg/kg lean body mass (LBM)

Placebo

Arm Description

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

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

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop varices (esophageal or gastric) requiring treatment
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 variceal bleed requiring hospitalization
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 clinically significant ascites requiring hospitalization
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 spontaneous bacterial peritonitis
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 hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization)
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 mortality (all-cause)
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 liver transplant
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 model for end-stage liver disease (MELD) score ≥15
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 Phase 3 treatment group who progress to large varices (gastric or esophageal) or develop red wales compared to placebo.
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: Event-free survival by time to first cirrhosis related clinical event, progression to large varices or red wales
Event-free survival by time to first cirrhosis related clinical event, progression to large varices or red wales
Efficacy: Event-free survival by time to first cirrhosis related clinical event, esophageal variceal hemorrhage requiring hospitalization
Event-free survival by time to first cirrhosis related clinical event, esophageal variceal hemorrhage requiring hospitalization
Efficacy: Event-free survival by time to first cirrhosis related clinical event, clinically significant ascites requiring hospitalization
Event-free survival by time to first cirrhosis related clinical event, clinically significant ascites requiring hospitalization
Efficacy: Event-free survival by time to first cirrhosis related clinical event, spontaneous bacterial peritonitis
Event-free survival by time to first cirrhosis related clinical event, spontaneous bacterial peritonitis
Efficacy: Event-free survival by time to first cirrhosis related clinical event, overt hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization)
Event-free survival by time to first cirrhosis related clinical event, overt hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization)
Efficacy: Event-free survival by time to first cirrhosis related clinical event, Child-Turcotte-Pugh (CTP) score increase of ≥2 points (from baseline)
Event-free survival by time to first cirrhosis related clinical event, Child-Turcotte-Pugh (CTP) score increase of ≥2 points (from baseline)
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
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
Efficacy: Event-free survival by time to first cirrhosis related clinical event, liver transplant
Event-free survival by time to first cirrhosis related clinical event, liver transplant
Efficacy: Event-free survival by time to first cirrhosis related clinical event, liver-related death
Event-free survival by time to first cirrhosis related clinical event, liver-related death

Full Information

First Posted
April 24, 2020
Last Updated
July 26, 2023
Sponsor
Galectin Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04365868
Brief Title
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
Acronym
NAVIGATE
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galectin Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
Keywords
esophageal varices, belapectin, GR-MD-02, portal hypertension, nonalcoholic steatohepatitis (NASH) cirrhosis, NASH, cirrhosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
belapectin 2 mg/kg lean body mass (LBM)
Arm Type
Experimental
Arm Description
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
Arm Title
belapectin 4 mg/kg lean body mass (LBM)
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
belapectin
Other Intervention Name(s)
GR-MD-02, galactoarabino rhamnogalacturonate
Intervention Description
intravenous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
intravenous
Primary Outcome Measure Information:
Title
Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks [18 months] of treatment compared to placebo
Description
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]
Secondary Outcome Measure Information:
Title
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop varices (esophageal or gastric) requiring treatment
Description
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
Title
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop variceal bleed requiring hospitalization
Description
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
Title
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop clinically significant ascites requiring hospitalization
Description
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
Title
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop spontaneous bacterial peritonitis
Description
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
Title
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)
Description
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
Title
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop mortality (all-cause)
Description
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
Title
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop liver transplant
Description
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
Title
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
Description
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
Title
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.
Description
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
Title
Efficacy: Event-free survival by time to first cirrhosis related clinical event, progression to large varices or red wales
Description
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
Title
Efficacy: Event-free survival by time to first cirrhosis related clinical event, esophageal variceal hemorrhage requiring hospitalization
Description
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
Title
Efficacy: Event-free survival by time to first cirrhosis related clinical event, clinically significant ascites requiring hospitalization
Description
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
Title
Efficacy: Event-free survival by time to first cirrhosis related clinical event, spontaneous bacterial peritonitis
Description
Event-free survival by time to first cirrhosis related clinical event, spontaneous bacterial peritonitis
Time Frame
Through study end, 78 weeks or 156 weeks
Title
Efficacy: Event-free survival by time to first cirrhosis related clinical event, overt hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization)
Description
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
Title
Efficacy: Event-free survival by time to first cirrhosis related clinical event, Child-Turcotte-Pugh (CTP) score increase of ≥2 points (from baseline)
Description
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
Title
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
Description
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
Title
Efficacy: Event-free survival by time to first cirrhosis related clinical event, liver transplant
Description
Event-free survival by time to first cirrhosis related clinical event, liver transplant
Time Frame
Through study end, 78 weeks or 156 weeks
Title
Efficacy: Event-free survival by time to first cirrhosis related clinical event, liver-related death
Description
Event-free survival by time to first cirrhosis related clinical event, liver-related death
Time Frame
Through study end, 78 weeks or 156 weeks
Other Pre-specified Outcome Measures:
Title
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
Description
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
Title
Exploratory Efficacy: Difference in Chronic Liver Disease Questionnaire (CLDQ) scores between belapectin and placebo treatment during Phase 2b and Phase 3
Description
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.
Time Frame
Through study end, 78 weeks or 156 weeks
Title
Safety: Incidence of adverse events
Description
Incidence of adverse events
Time Frame
Through study end, 78 weeks or 156 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pol Boudes, M.D.
Organizational Affiliation
Galectin Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Digestive Health Specialists
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
The Institute for Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Arizona Liver Health - Glendale
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Institute for Liver Health - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Liver Wellness Center - Little Rock
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-6414
Country
United States
Facility Name
Hope Clinical Research, Inc.
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Southern California GI & Liver Centers
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
University of California San Diego Medical Center -La Jolla Multi-Specialty Clinics- Perlman Offices
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Om Research LLC
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
inSite Digestive Health Care - Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907-6262
Country
United States
Facility Name
Integrity Clinical Research, LLC (ICR SITES) - Doral
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Nature Coast Clinical Research, LLC
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Mayo Clinic Hospital - Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224-1865
Country
United States
Facility Name
Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
ClinCloud LLC
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751-3320
Country
United States
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
Genoma Research Group, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Sensible Healthcare
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Guardian Angel Health Services, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Florida Medical Center & Research
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Digestive Healthcare of Georgia, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Loyola University Health System
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Michiana Gastroenterology, Inc.
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46635
Country
United States
Facility Name
Kansas Medical Clinic PA
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Louisville Physicians - Cardiovascular Medicine Physicians Outpatient Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-2046
Country
United States
Facility Name
Tandem Clinical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Tulane Cancer Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2600
Country
United States
Facility Name
Mercy Medical Center - The Institute for Digestive Health and Liver Disease
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System - Hemophilia and Thrombosis Treatment Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Southern Therapy and Advanced Research (STAR) - Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Excel Clinical Research - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109-6209
Country
United States
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016-6402
Country
United States
Facility Name
NewYork-Presbyterian Hospital/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
UNC-Chapel Hill School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
273302
Country
United States
Facility Name
Cumberland Research Associates, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304-3571
Country
United States
Facility Name
Lucas Research
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
University of Cincinnati Physicians Company, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0595
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44016
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
The Jefferson Digestive Health Institute - Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Galen Medical Group - Ziegler Plaza
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37343-5470
Country
United States
Facility Name
University Diabetes & Endocrine Consultants
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37411
Country
United States
Facility Name
Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Associates in Gastroenterology
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
East Tennessee Research Institute - Gastrointestinal Associates of Northeast Tennessee, P.C.
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604-6063
Country
United States
Facility Name
Texas Clinical Research Institute, LLC
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Liver Specialists of Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Methodist Transplant Physicians
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Texoma Liver Center PLLC. - Denison
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
Facility Name
South Texas Research Institute
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Baylor College of Medicine - Baylor Clinic - Abdominal Transplant & Liver Disease Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pioneer Research Solutions Inc - Houston - Stancliff Rd
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
The Texas Liver Institute, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Impact Research Institute
City
Waco
State/Province
Texas
ZIP/Postal Code
76710-2582
Country
United States
Facility Name
University of Utah Health Care - UUHC - Kidney & Liver Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-0001
Country
United States
Facility Name
University of Virginia School of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Gastroenterology Associates of Fredericksburg
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401-8425
Country
United States
Facility Name
Bon Secours Liver Institute of Virginia - Newport News
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Bon Secours Liver Institute of Virginia - Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249-0001
Country
United States
Facility Name
Velocity Clinical Research, Spokane
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202-3462
Country
United States
Facility Name
Hospital Británico de Buenos Aires
City
Buenos Aires
State/Province
ARG
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
Capital federal
State/Province
ARG
ZIP/Postal Code
C1056ABJ
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Ciudad Autonoma de Buenos aires
State/Province
ARG
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2750
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Medical Centre Clayton
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Clinique Universitaire De Bruxelles Hôpital Erasme VZW
City
Brussels
State/Province
BEL
ZIP/Postal Code
1070
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
State/Province
VOV
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
VOV
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Groupe sante CHC - Clinique du MontLegia
City
Liège
State/Province
WLG
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University of Calgary - Heritage Medical Research Clinic - Foothills Hospital Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Pacific Gastroenterology Associates
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Brampton Civic Hospital
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Hospital de La Serena
City
La Serena
State/Province
CHL
ZIP/Postal Code
1710216
Country
Chile
Facility Name
Clínica Universidad de los Andes
City
Santiago
State/Province
CHL
ZIP/Postal Code
7550000
Country
Chile
Facility Name
Centro de Investigaciones Clinicas Vina del Mar
City
Viña Del Mar
State/Province
CHL
ZIP/Postal Code
07081-2221
Country
Chile
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
ZIP/Postal Code
8380000
Country
Chile
Facility Name
Centre Hospitalier Universitaire d'Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
CHU Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hôpital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
CHRU Montpellier - Saint Eloi
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
CHU Nancy - Hôpital Brabois
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
CHU de Nice - L'Archet
City
Nice
ZIP/Postal Code
6202
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg - Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
City
Mainz
State/Province
RP
ZIP/Postal Code
55131
Country
Germany
Facility Name
EUGASTRO GmbH
City
Leipzig
State/Province
SN
ZIP/Postal Code
4103
Country
Germany
Facility Name
Goethe-Universität Frankfurt am Main
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Soroka Medical Center
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Hadassah Ein Karem Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Holy Family Hospital
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petah Tiqwa
ZIP/Postal Code
4941492
Country
Israel
Facility Name
The Chaim Sheba Medical Center - The Center for Liver Diseases
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Hanyang University Seoul Hospital
City
Seoul
State/Province
KOR
ZIP/Postal Code
4763
Country
Korea, Republic of
Facility Name
Yonsei University, Wonju Severance Christian Hospital
City
Seoul
State/Province
KOR
ZIP/Postal Code
8308
Country
Korea, Republic of
Facility Name
Yonsei University, Wonju Severance Christian Hospital
City
Wŏnju
State/Province
KOR
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Digestive Research Alliance of Michiana, LLC
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
CEMDEC SA de CV Centro Mexicano de Desarrollo de Estudios Clinicos
City
Cuauhtémoc
State/Province
Ciudad De Mexico
ZIP/Postal Code
06100
Country
Mexico
Facility Name
Investigacion Biomedica para el desarrollo de farmacos SA de CV
City
Benito Juarez
State/Province
Ciudad De México
ZIP/Postal Code
03103
Country
Mexico
Facility Name
Centro Especializado en Diabetes, Obesidad y Pevencion de enfermedades Cadiovasculares SC.
City
Miguel Hidalgo
State/Province
Ciudad De México
ZIP/Postal Code
11650
Country
Mexico
Facility Name
CICPA Centro de Investigación Clinica del Pacifico
City
Acapulco de Juárez
State/Province
Guerrero
ZIP/Postal Code
39670
Country
Mexico
Facility Name
Centro de Investigacion Medico Biologica y Terapia Avanzada SC
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Investigacion Biomedica para el desarrollo de farmacos SA de CV
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Consultorio Medico
City
Ciudad De Mexico
State/Province
MEX
ZIP/Postal Code
6700
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez Servicio de Gastroenterología
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Oaxaca Site Management Organization SC.
City
Oaxaca de Juarez
State/Province
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Medical Care and Research SA de CV
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Centro de Investigación Medica de Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20116
Country
Mexico
Facility Name
MEDIVEST Centro de Investigacion integral
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Centro de Investigacion Clinica de Oaxaca
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Facility Name
Medical University of Lodz
City
Łódź
State/Province
LD
ZIP/Postal Code
91-347
Country
Poland
Facility Name
SP CSK im Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
State/Province
SL
ZIP/Postal Code
40-752
Country
Poland
Facility Name
ID Clinic
City
Mysłowice
State/Province
SL
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Medyczny Katedra i Klinika Chorób Zakaźnych, Chorób Wątroby i Nabytych Niedoborów Odpornościowych
City
Wrocław
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
State/Province
ESP
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital del Mar Research Institute
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Pontevedra
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
King's College Hospital NHS Foundation Trust
City
London
State/Province
GBR
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit
City
Nottingham
State/Province
NGM
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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