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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04365868
Other study ID # GT-031
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 22, 2020
Est. completion date December 2024

Study information

Verified date November 2023
Source Galectin Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 hypertension but without esophageal varices at baseline.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 357
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 ß-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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
belapectin
intravenous
Placebo
intravenous

Locations

Country Name City State
Argentina Hospital Británico de Buenos Aires Buenos Aires ARG
Argentina Centro de Investigaciones Metabólicas (CINME) Capital federal ARG
Argentina Hospital Italiano de Buenos Aires Ciudad Autonoma de Buenos aires ARG
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Box Hill Hospital Box Hill Victoria
Australia Monash Medical Centre Clayton Clayton Victoria
Australia Nepean Hospital Kingswood New South Wales
Australia Fiona Stanley Hospital Murdoch Western Australia
Belgium Clinique Universitaire De Bruxelles Hôpital Erasme VZW Brussels BEL
Belgium Antwerp University Hospital Edegem Antwerpen
Belgium AZ Maria Middelares Gent VOV
Belgium Universitair Ziekenhuis Gent Gent VOV
Belgium Groupe sante CHC - Clinique du MontLegia Liège WLG
Canada Brampton Civic Hospital Brampton Ontario
Canada University of Calgary - Heritage Medical Research Clinic - Foothills Hospital Center Calgary Alberta
Canada Centre Hospitalier de l'Université de Montréal (CHUM) Montréal Quebec
Canada Toronto Liver Centre Toronto Ontario
Canada Pacific Gastroenterology Associates Vancouver British Columbia
Chile Hospital de La Serena La Serena CHL
Chile Clínica Universidad de los Andes Santiago CHL
Chile Hospital Clínico Universidad de Chile Santiago
Chile Centro de Investigaciones Clinicas Vina del Mar Viña Del Mar CHL
France Centre Hospitalier Universitaire d'Amiens Amiens
France Hôpital Avicenne Bobigny
France CHU Hôpital Henri Mondor Créteil
France CHU de Grenoble Grenoble
France Hôpital de la Croix-Rousse Lyon
France CHRU Montpellier - Saint Eloi Montpellier
France CHU Nancy - Hôpital Brabois Nancy
France CHU de Nice - L'Archet Nice
France Hôpital Cochin Paris
France Hôpitaux Universitaires de Strasbourg - Hôpital Civil Strasbourg
Germany Goethe-Universität Frankfurt am Main Frankfurt am Main
Germany EUGASTRO GmbH Leipzig SN
Germany Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Mainz RP
Israel Soroka Medical Center Be'er Sheva
Israel Carmel Medical Center Haifa
Israel Rambam 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
Korea, Republic of Digestive Research Alliance of Michiana, LLC Incheon
Korea, Republic of Hanyang University Seoul Hospital Seoul KOR
Korea, Republic of Yonsei University, Wonju Severance Christian Hospital Seoul KOR
Korea, Republic of Yonsei University, Wonju Severance Christian Hospital Wonju KOR
Mexico CICPA Centro de Investigación Clinica del Pacifico Acapulco de Juárez Guerrero
Mexico Centro de Investigación Medica de Aguascalientes Aguascalientes
Mexico Investigacion Biomedica para el desarrollo de farmacos SA de CV Benito Juarez Ciudad De México
Mexico MEDIVEST Centro de Investigacion integral Chihuahua
Mexico Consultorio Medico Ciudad De Mexico MEX
Mexico CEMDEC SA de CV Centro Mexicano de Desarrollo de Estudios Clinicos Cuauhtémoc Ciudad De Mexico
Mexico Centro de Investigacion Medico Biologica y Terapia Avanzada SC Guadalajara Jalisco
Mexico Medical Care and Research SA de CV Mérida Yucatan
Mexico Centro Especializado en Diabetes, Obesidad y Pevencion de enfermedades Cadiovasculares SC. Miguel Hidalgo Ciudad De México
Mexico Hospital Universitario Dr. Jose Eleuterio Gonzalez Servicio de Gastroenterología Monterrey Nuevo Leon
Mexico Centro de Investigacion Clinica de Oaxaca Oaxaca
Mexico Oaxaca Site Management Organization SC. Oaxaca de Juarez Oaxaca
Mexico Investigacion Biomedica para el desarrollo de farmacos SA de CV Zapopan Jalisco
Poland SP CSK im Prof. Kornela Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach Katowice SL
Poland Medical University of Lodz Lódz LD
Poland ID Clinic Myslowice SL
Poland Medyczny Katedra i Klinika Chorób Zakaznych, Chorób Watroby i Nabytych Niedoborów Odpornosciowych Wroclaw
Puerto Rico Fundacion de Investigacion de Diego San Juan
Spain Hospital del Mar Research Institute Barcelona
Spain Hospital Universitario 12 de Octubre Madrid ESP
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Hospital Universitario Puerta de Hierro - Majadahonda Majadahonda
Spain Complexo Hospitalario Universitario de Pontevedra Pontevedra
Spain Hospital Universitario Marqués de Valdecilla Santander
Spain Hospital Universitario Virgen del Rocío Sevilla
United Kingdom 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 States University of Michigan Ann Arbor Michigan
United States Texas Clinical Research Institute, LLC Arlington Texas
United States Digestive Healthcare of Georgia, P.C. Atlanta Georgia
United States University of Colorado Anschutz Medical Campus Aurora Colorado
United States Liver Specialists of Texas Austin Texas
United States Mercy Medical Center - The Institute for Digestive Health and Liver Disease Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Tufts Medical Center Boston Massachusetts
United States Hope Clinical Research, Inc. Canoga Park California
United States The Institute for Liver Health Chandler Arizona
United States UNC-Chapel Hill School of Medicine Chapel Hill North Carolina
United States Medical University of South Carolina (MUSC) Charleston South Carolina
United States University of Virginia School of Medicine Charlottesville Virginia
United States Galen Medical Group - Ziegler Plaza Chattanooga Tennessee
United States University Diabetes & Endocrine Consultants Chattanooga Tennessee
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 Peak Gastroenterology Associates Colorado Springs Colorado
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States Southern California GI & Liver Centers Coronado California
United States Methodist Transplant Physicians Dallas Texas
United States Texoma Liver Center PLLC. - Denison Denison Texas
United States Henry Ford Health System - Hemophilia and Thrombosis Treatment Center Detroit Michigan
United States Integrity Clinical Research, LLC (ICR SITES) - Doral Doral Florida
United States Digestive Health Specialists Dothan Alabama
United States South Texas Research Institute Edinburg Texas
United States Cumberland Research Associates, LLC Fayetteville North Carolina
United States Gastroenterology Associates of Fredericksburg Fredericksburg Virginia
United States Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park Germantown Tennessee
United States Arizona Liver Health - Glendale Glendale Arizona
United States Associates in Gastroenterology Hermitage Tennessee
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
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 IU Health University Hospital Indianapolis Indiana
United States Nature Coast Clinical Research, LLC Inverness Florida
United States Southern Therapy and Advanced Research (STAR) - Jackson Jackson Mississippi
United States Mayo Clinic Hospital - Florida Jacksonville Florida
United States East Tennessee Research Institute - Gastrointestinal Associates of Northeast Tennessee, P.C. Johnson City Tennessee
United States Kansas City Research Institute Kansas City Missouri
United States University of California San Diego Medical Center -La Jolla Multi-Specialty Clinics- Perlman Offices La Jolla California
United States Florida Research Institute Lakewood Ranch Florida
United States Om Research LLC Lancaster California
United States Excel Clinical Research - Las Vegas Las Vegas Nevada
United States Liver Wellness Center - Little Rock Little Rock Arkansas
United States Cedars-Sinai Medical Center Los Angeles California
United States University of Louisville Physicians - Cardiovascular Medicine Physicians Outpatient Center Louisville Kentucky
United States Gastroenterology Associates of Central Georgia, LLC Macon Georgia
United States ClinCloud LLC Maitland Florida
United States Gastrointestinal Specialists of Georgia, PC Marietta Georgia
United States Tandem Clinical Research, LLC Marrero Louisiana
United States Loyola University Health System Maywood Illinois
United States Advanced Pharma CR, LLC Miami Florida
United States Genoma Research Group, Inc. Miami Florida
United States Lucas Research Morehead City North Carolina
United States Tulane Cancer Center New Orleans Louisiana
United States Columbia University Medical Center New York New York
United States Mount Sinai Beth Israel New York New York
United States NewYork-Presbyterian Hospital/Weill Cornell Medical Center New York New York
United States NYU Langone Medical Center New York New York
United States Bon Secours Liver Institute of Virginia - Newport News Newport News Virginia
United States Sensible Healthcare Ocoee Florida
United States inSite Digestive Health Care - Orange Orange California
United States California Liver Research Institute Pasadena California
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 Inland Empire Liver Foundation Rialto California
United States Bon Secours Liver Institute of Virginia - Richmond Richmond Virginia
United States Hunter Holmes McGuire VA Medical Center Richmond Virginia
United States University of Utah Health Care - UUHC - Kidney & Liver Clinic Salt Lake City Utah
United States Pinnacle Clinical Research San Antonio Texas
United States The Texas Liver Institute, Inc. San Antonio Texas
United States Michiana Gastroenterology, Inc. South Bend Indiana
United States Velocity Clinical Research, Spokane Spokane Washington
United States Guardian Angel Health Services, Inc. Tampa Florida
United States Kansas Medical Clinic PA Topeka Kansas
United States Institute for Liver Health - Tucson Tucson Arizona
United States Impact Research Institute Waco Texas
United States Gastroenterology Associates of Western Michigan Wyoming Michigan
United States Florida Medical Center & Research Zephyrhills Florida

Sponsors (1)

Lead Sponsor Collaborator
Galectin Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Chile,  France,  Germany,  Israel,  Korea, Republic of,  Mexico,  Poland,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 Change in liver stiffness measurement (LSM), baseline-adjusted, as determined by vibration controlled transient elastography (VCTE) (FibroScan) exams during Phase 2b and Phase 3 Through study end, 78 weeks or 156 weeks
Other Exploratory Efficacy: Difference in Chronic Liver Disease Questionnaire (CLDQ) scores between belapectin and placebo treatment during Phase 2b and Phase 3 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. Through study end, 78 weeks or 156 weeks
Other Safety: Incidence of adverse events Incidence of adverse events Through study end, 78 weeks or 156 weeks
Primary 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 At 78 weeks [18 months]
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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) Through study end, 78 weeks or 156 weeks
Secondary 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) Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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) Through study end, 78 weeks or 156 weeks
Secondary 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) Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
Secondary 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 Through study end, 78 weeks or 156 weeks
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