Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
- Conditions
- Prevention of Esophageal VaricesCirrhosisNASH - Nonalcoholic Steatohepatitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT04365868
- Lead Sponsor
- Galectin Therapeutics Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 357
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.
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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.
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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.
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).
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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.
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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.
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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.
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Has known allergies to the IMP or any of its excipients.
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Has previously received belapectin within 6 months of randomization.
-
Is an employee or family member of the Investigator or study center personnel.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description belapectin 4 mg/kg lean body mass (LBM) belapectin 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 Placebo Placebo Phase 2b: Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) Phase 3:Placebo, administered intravenously (IV) every other week for 78 weeks (18 months) belapectin 2 mg/kg lean body mass (LBM) belapectin 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
- Primary Outcome Measures
Name Time Method 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] 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
Name Time Method Efficacy: 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 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 model for end-stage liver disease (MELD) score ≥15 Through study end, 78 weeks or 156 weeks Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop model for end-stage liver disease (MELD) score ≥15
Efficacy: 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 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, Child-Turcotte-Pugh (CTP) score increase of ≥2 points (from baseline) Through study end, 78 weeks or 156 weeks Event-free survival by time to first cirrhosis related clinical event, Child-Turcotte-Pugh (CTP) score increase of ≥2 points (from baseline)
Efficacy: 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 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 varices (esophageal or gastric) requiring treatment Through study end, 78 weeks or 156 weeks Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop varices (esophageal or gastric) requiring treatment
Efficacy: 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 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 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 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, clinically significant ascites requiring hospitalization Through study end, 78 weeks or 156 weeks 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 Through study end, 78 weeks or 156 weeks Event-free survival by time to first cirrhosis related clinical event, spontaneous bacterial peritonitis
Efficacy: 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 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 spontaneous bacterial peritonitis Through study end, 78 weeks or 156 weeks Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop spontaneous bacterial peritonitis
Efficacy: 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 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, liver transplant Through study end, 78 weeks or 156 weeks 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 Through study end, 78 weeks or 156 weeks Event-free survival by time to first cirrhosis related clinical event, liver-related death
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) Through study end, 78 weeks or 156 weeks Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop hepatic encephalopathy (West Haven score ≥2 and requiring hospitalization)
Efficacy: Event-free survival by time to first cirrhosis related clinical event, esophageal variceal hemorrhage requiring hospitalization Through study end, 78 weeks or 156 weeks 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, 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 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
Trial Locations
- Locations (154)
Impact Research Institute
🇺🇸Waco, Texas, United States
Hospital de La Serena
🇨🇱La Serena, CHL, Chile
Clínica Universidad de los Andes
🇨🇱Santiago, CHL, Chile
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
University of Louisville Physicians - Cardiovascular Medicine Physicians Outpatient Center
🇺🇸Louisville, Kentucky, 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
Kansas City Research Institute
🇺🇸Kansas City, Missouri, United States
Henry Ford Health System - Hemophilia and Thrombosis Treatment Center
🇺🇸Detroit, Michigan, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Gastroenterology Associates of Western Michigan
🇺🇸Wyoming, Michigan, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States
Southern Therapy and Advanced Research (STAR) - Jackson
🇺🇸Jackson, Mississippi, United States
Mount Sinai Beth Israel
🇺🇸New York, New York, United States
Excel Clinical Research - Las Vegas
🇺🇸Las Vegas, Nevada, 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
UNC-Chapel Hill School of Medicine
🇺🇸Chapel Hill, 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
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, 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
🇺🇸Pittsburg, 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
East Tennessee Research Institute - Gastrointestinal Associates of Northeast Tennessee, P.C.
🇺🇸Johnson City, 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 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, 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 Hôpital Erasme VZW
🇧🇪Brussels, BEL, Belgium
AZ Maria Middelares
🇧🇪Gent, VOV, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, VOV, Belgium
Groupe sante CHC - Clinique du MontLegia
🇧🇪Liège, 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'Université de Montréal (CHUM)
🇨🇦Montréal, Quebec, Canada
Centro de Investigaciones Clinicas Vina del Mar
🇨🇱Viña Del Mar, CHL, Chile
Hospital Clínico Universidad de Chile
🇨🇱Santiago, Chile
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, France
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
🇩🇪Mainz, RP, Germany
EUGASTRO GmbH
🇩🇪Leipzig, SN, Germany
Goethe-Universität 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
Hanyang University Seoul Hospital
🇰🇷Seoul, KOR, Korea, Republic of
Yonsei University, Wonju Severance Christian Hospital
🇰🇷Wŏnju, KOR, Korea, Republic of
Digestive Research Alliance of Michiana, LLC
🇰🇷Incheon, Korea, Republic of
CEMDEC SA de CV Centro Mexicano de Desarrollo de Estudios Clinicos
🇲🇽Cuauhtémoc, Ciudad de Mexico, Mexico
Investigacion Biomedica para el desarrollo de farmacos SA de CV
🇲🇽Zapopan, Jalisco, Mexico
Centro Especializado en Diabetes, Obesidad y Pevencion de enfermedades Cadiovasculares SC.
🇲🇽Miguel Hidalgo, Ciudad de México, Mexico
CICPA Centro de Investigación Clinica del Pacifico
🇲🇽Acapulco de Juárez, Guerrero, Mexico
Centro de Investigacion Medico Biologica y Terapia Avanzada SC
🇲🇽Guadalajara, Jalisco, Mexico
Consultorio Medico
🇲🇽Ciudad De Mexico, MEX, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez Servicio de Gastroenterología
🇲🇽Monterrey, Nuevo Leon, Mexico
Oaxaca Site Management Organization SC.
🇲🇽Oaxaca de Juarez, Oaxaca, Mexico
Medical Care and Research SA de CV
🇲🇽Mérida, Yucatan, Mexico
Centro de Investigación Medica de Aguascalientes
🇲🇽Aguascalientes, Mexico
MEDIVEST Centro de Investigacion integral
🇲🇽Chihuahua, Mexico
Centro de Investigacion Clinica de Oaxaca
🇲🇽Oaxaca, Mexico
Medical University of Lodz
🇵🇱Łódź, LD, Poland
SP CSK im Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach
🇵🇱Katowice, SL, Poland
ID Clinic
🇵🇱Mysłowice, SL, Poland
Medyczny Katedra i Klinika Chorób Zakaźnych, Chorób Wątroby i Nabytych Niedoborów Odpornościowych
🇵🇱Wrocław, 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 Ramón 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 Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Universitario Virgen del Rocío
🇪🇸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