Clinical Trial Details

Trial ID: L0362
Source ID: NCT04365868
Associated Drug: Belapectin
Title: Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
Acronym: NAVIGATE
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Prevention of Esophageal Varices|NASH - Nonalcoholic Steatohepatitis|Cirrhosis
Interventions: Drug: belapectin|Drug: Placebo
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|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 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|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 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)|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 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.|Efficacy: 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|Efficacy: 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|Efficacy: 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)|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|Efficacy: 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
Sponsor/Collaborators: Galectin Therapeutics Inc.
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2/Phase 3
Enrollment: 1010
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Prevention
Start Date: June 22, 2020
Completion Date: December 2023
Results First Posted: --
Last Update Posted: March 7, 2022
Locations: University of Alabama at Birmingham, Birmingham, Alabama, United States|Digestive Health Specialists, Dothan, Alabama, United States|The Institute for Liver Health, Chandler, Arizona, United States|Arizona Liver Health - Glendale, Glendale, Arizona, United States|Institute for Liver Health - Tucson, Tucson, Arizona, United States|Liver Wellness Center - Little Rock, Little Rock, Arkansas, United States|Hope Clinical Research, Inc., Canoga Park, California, United States|Southern California GI & Liver Centers, Coronado, California, United States|University of California San Diego Medical Center -La Jolla Multi-Specialty Clinics- Perlman Offices, La Jolla, California, United States|Om Research LLC, Lancaster, California, United States|Cedars-Sinai Medical Center, Los Angeles, California, United States|inSite Digestive Health Care - Orange, Orange, California, United States|California Liver Research Institute, Pasadena, California, United States|Inland Empire Liver Foundation, Rialto, California, United States|University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States|Peak Gastroenterology Associates, Colorado Springs, Colorado, United States|Integrity Clinical Research, LLC (ICR SITES) - Doral, Doral, Florida, United States|Nature Coast Clinical Research, LLC, Inverness, Florida, United States|Mayo Clinic Hospital - Florida, Jacksonville, Florida, United States|Florida Research Institute, Lakewood Ranch, Florida, United States|ClinCloud LLC, Maitland, Florida, United States|Advanced Pharma CR, LLC, Miami, Florida, United States|Genoma Research Group, Inc., Miami, Florida, United States|Sensible Healthcare, Ocoee, Florida, United States|Guardian Angel Health Services, Inc., Tampa, Florida, United States|Florida Medical Center & Research, Zephyrhills, Florida, United States|Digestive Healthcare of Georgia, P.C., Atlanta, Georgia, United States|Gastroenterology Associates of Central Georgia, LLC, Macon, Georgia, United States|Gastrointestinal Specialists of Georgia, PC, Marietta, Georgia, United States|Loyola University Health System, Maywood, Illinois, United States|IU Health University Hospital, Indianapolis, Indiana, United States|Michiana Gastroenterology, Inc., South Bend, Indiana, United States|Kansas Medical Clinic PA, Topeka, Kansas, United States|Tandem Clinical Research, LLC, Marrero, Louisiana, United States|Tulane Cancer Center, New Orleans, Louisiana, United States|Mercy Medical Center - The Institute for Digestive Health and Liver Disease, Baltimore, Maryland, United States|Tufts Medical Center, Boston, Massachusetts, United States|University of Michigan, Ann Arbor, Michigan, United States|Henry Ford Health System - Hemophilia and Thrombosis Treatment Center, Detroit, Michigan, United States|Gastroenterology Associates of Western Michigan, Wyoming, Michigan, United States|Southern Therapy and Advanced Research (STAR) - Jackson, Jackson, Mississippi, United States|Kansas City Research Institute, Kansas City, Missouri, United States|Excel Clinical Research - Las Vegas, Las Vegas, Nevada, United States|Mount Sinai Beth Israel, New York, New York, United States|NYU Langone Medical Center, New York, New York, United States|NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York, United States|Columbia University Medical Center, New York, New York, United States|UNC-Chapel Hill School of Medicine, Chapel Hill, North Carolina, United States|Cumberland Research Associates, LLC, Fayetteville, North Carolina, United States|Lucas Research, Morehead City, North Carolina, United States|Consultants for Clinical Research, Cincinnati, Ohio, United States|University of Cincinnati Physicians Company, LLC, Cincinnati, Ohio, United States|University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States|The Ohio State University Wexner Medical Center, Columbus, Ohio, United States|The Jefferson Digestive Health Institute - Thomas Jefferson University, Philadelphia, Pennsylvania, United States|University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases, Pittsburgh, Pennsylvania, United States|Medical University of South Carolina (MUSC), Charleston, South Carolina, United States|Galen Medical Group - Ziegler Plaza, Chattanooga, Tennessee, United States|University Diabetes & Endocrine Consultants, Chattanooga, Tennessee, United States|Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park, Germantown, Tennessee, United States|Associates in Gastroenterology, Hermitage, Tennessee, United States|Texas Clinical Research Institute, LLC, Arlington, Texas, United States|Liver Specialists of Texas, Austin, Texas, United States|Methodist Transplant Physicians, Dallas, Texas, United States|Texoma Liver Center PLLC. - Denison, Denison, Texas, United States|South Texas Research Institute, Edinburg, Texas, United States|Baylor College of Medicine - Baylor Clinic - Abdominal Transplant & Liver Disease Clinic, Houston, Texas, United States|Pioneer Research Solutions Inc - Houston - Stancliff Rd, Houston, Texas, United States|The Texas Liver Institute, Inc., San Antonio, Texas, United States|Pinnacle Clinical Research, San Antonio, Texas, United States|University of Utah Health Care - UUHC - Kidney & Liver Clinic, Salt Lake City, Utah, United States|University of Virginia School of Medicine, Charlottesville, Virginia, United States|Gastroenterology Associates of Fredericksburg, Fredericksburg, Virginia, United States|Bon Secours Liver Institute of Virginia - Newport News, Newport News, Virginia, United States|Bon Secours Liver Institute of Virginia - Richmond, Richmond, Virginia, United States|Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, United States|Velocity Clinical Research, Spokane, Spokane, Washington, United States|Hospital Brit??nico de Buenos Aires, Buenos Aires, ARG, Argentina|Centro de Investigaciones Metab??licas (CINME), Capital federal, ARG, Argentina|Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos aires, ARG, Argentina|Nepean Hospital, Kingswood, New South Wales, Australia|Royal Adelaide Hospital, Adelaide, South Australia, Australia|Box Hill Hospital, Box Hill, Victoria, Australia|Monash Medical Centre Clayton, Clayton, Victoria, Australia|Fiona Stanley Hospital, Murdoch, Western Australia, Australia|Antwerp University Hospital, Edegem, Antwerpen, Belgium|Clinique Universitaire De Bruxelles H??pital Erasme VZW, Brussels, BEL, Belgium|AZ Maria Middelares, Gent, VOV, Belgium|Universitair Ziekenhuis Gent, Gent, VOV, Belgium|Groupe sante CHC - Clinique du MontLegia, Li??ge, WLG, Belgium|University of Calgary - Heritage Medical Research Clinic - Foothills Hospital Center, Calgary, Alberta, Canada|Pacific Gastroenterology Associates, Vancouver, British Columbia, Canada|Brampton Civic Hospital, Brampton, Ontario, Canada|Toronto Liver Centre, Toronto, Ontario, Canada|Centre Hospitalier de l'Universit?? de Montr??al (CHUM), Montr??al, Quebec, Canada|Hospital de La Serena, La Serena, CHL, Chile|Cl??nica Universidad de los Andes, Santiago, CHL, Chile|Centro de Investigaciones Clinicas Vina del Mar, Vi??a Del Mar, CHL, Chile|Centre Hospitalier Universitaire d'Amiens, Amiens, France|H??pital Avicenne, Bobigny, France|CHU H??pital Henri Mondor, Cr??teil, France|CHU de Grenoble, Grenoble, France|Hospices Civils De Lyon, Lyon, France|CHRU Montpellier - Saint Eloi, Montpellier, France|CHU Nancy - H??pital Brabois, Nancy, France|CHU de Nice - L'Archet, Nice, France|H??pital Cochin, Paris, France|H??pitaux Universitaires de Strasbourg - H??pital Civil, Strasbourg, France|Universitatsmedizin der Johannes Gutenberg-Universitat Mainz, Mainz, RP, Germany|EUGASTRO GmbH, Leipzig, SN, Germany|Goethe-Universit??t Frankfurt am Main, Frankfurt am Main, Germany|Soroka Medical Center, Be'er Sheva, Israel|Rambam Medical Center, Haifa, Israel|Carmel Medical Center, Haifa, Israel|Hadassah Ein Karem Hospital, Jerusalem, Israel|Holy Family Hospital, Nazareth, Israel|Rabin Medical Center - Beilinson Hospital, Petah Tiqwa, Israel|The Chaim Sheba Medical Center - The Center for Liver Diseases, Ramat Gan, Israel|Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel|Seoul National University Hospital, Seoul, KOR, Korea, Republic of|Yonsei University, Wonju Severance Christian Hospital, W??nju, KOR, Korea, Republic of|Consultorio Medico, Ciudad De Mexico, MEX, Mexico|Medical University of Lodz, ????d??, LD, Poland|SP CSK im Prof. Kornela Gibi??skiego ??l??skiego Uniwersytetu Medycznego w Katowicach, Katowice, SL, Poland|ID Clinic, Mys??owice, SL, Poland|Medyczny Katedra i Klinika Chor??b Zaka??nych, Chor??b W??troby i Nabytych Niedobor??w Odporno??ciowych, Wroc??aw, Poland|Fundacion de Investigacion de Diego, San Juan, Puerto Rico|Hospital Universitario 12 de Octubre, Madrid, ESP, Spain|Hospital del Mar Research Institute, Barcelona, Spain|Hospital Universitario Ram??n y Cajal, Madrid, Spain|Hospital Universitario La Paz, Madrid, Spain|Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda, Spain|Complexo Hospitalario Universitario de Pontevedra, Pontevedra, Spain|Hospital Universitario Marqu??s de Valdecilla, Santander, Spain|Hospital Universitario Virgen del Roc??o, Sevilla, Spain|King's College Hospital NHS Foundation Trust, London, GBR, United Kingdom|The University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit, Nottingham, NGM, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT04365868

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D028 Belapectin Chemical drug DB15125 Gelactin-3 inhibitor; LGALS3 inhibitor Anti-fibrosis Failed in clinical trials Details
D080 Citrulline Chemical drug DB00155 -- -- Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details