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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04365868




Registration number
NCT04365868
Ethics application status
Date submitted
24/04/2020
Date registered
28/04/2020

Titles & IDs
Public title
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
Scientific 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
Secondary ID [1] 0 0
GT-031
Universal Trial Number (UTN)
Trial acronym
NAVIGATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Esophageal Varices 0 0
NASH - Nonalcoholic Steatohepatitis 0 0
Cirrhosis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - belapectin
Treatment: Drugs - Placebo

Experimental: belapectin 2 mg/kg lean body mass (LBM) - 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

Experimental: belapectin 4 mg/kg lean body mass (LBM) - 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 comparator: 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)


Treatment: Drugs: belapectin
intravenous

Treatment: Drugs: Placebo
intravenous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients in the belapectin treatment groups who develop new esophageal varices at 78 weeks [18 months] of treatment compared to placebo
Timepoint [1] 0 0
At 78 weeks [18 months]
Secondary outcome [1] 0 0
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop varices (esophageal or gastric) requiring treatment
Timepoint [1] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [2] 0 0
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop variceal bleed requiring hospitalization
Timepoint [2] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [3] 0 0
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop clinically significant ascites requiring hospitalization
Timepoint [3] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [4] 0 0
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop spontaneous bacterial peritonitis
Timepoint [4] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [5] 0 0
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)
Timepoint [5] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [6] 0 0
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop mortality (all-cause)
Timepoint [6] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [7] 0 0
Efficacy: Cumulative incidence rate of patients in the belapectin treatment groups, compared to placebo, who develop liver transplant
Timepoint [7] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [10] 0 0
Efficacy: Event-free survival by time to first cirrhosis related clinical event, progression to large varices or red wales
Timepoint [10] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [11] 0 0
Efficacy: Event-free survival by time to first cirrhosis related clinical event, esophageal variceal hemorrhage requiring hospitalization
Timepoint [11] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [12] 0 0
Efficacy: Event-free survival by time to first cirrhosis related clinical event, clinically significant ascites requiring hospitalization
Timepoint [12] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [13] 0 0
Efficacy: Event-free survival by time to first cirrhosis related clinical event, spontaneous bacterial peritonitis
Timepoint [13] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [14] 0 0
Efficacy: Event-free survival by time to first cirrhosis related clinical event, overt hepatic encephalopathy (West Haven score =2 and requiring hospitalization)
Timepoint [14] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [15] 0 0
Efficacy: Event-free survival by time to first cirrhosis related clinical event, Child-Turcotte-Pugh (CTP) score increase of =2 points (from baseline)
Timepoint [15] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [17] 0 0
Efficacy: Event-free survival by time to first cirrhosis related clinical event, liver transplant
Timepoint [17] 0 0
Through study end, 78 weeks or 156 weeks
Secondary outcome [18] 0 0
Efficacy: Event-free survival by time to first cirrhosis related clinical event, liver-related death
Timepoint [18] 0 0
Through study end, 78 weeks or 156 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
357
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Monash Medical Centre Clayton - Clayton
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2750 - Kingswood
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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Arkansas
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Illinois
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Indiana
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Washington
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Argentina
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ARG
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Belgium
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Antwerpen
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Belgium
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BEL
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Belgium
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VOV
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Belgium
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WLG
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Quebec
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Chile
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CHL
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Chile
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Santiago
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France
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Amiens
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Bobigny
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Nice
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Germany
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RP
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SN
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Frankfurt am Main
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Israel
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Be'er Sheva
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Haifa
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Jerusalem
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Nazareth
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Israel
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Petah Tiqwa
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Israel
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Ramat Gan
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Israel
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Tel-Aviv
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Korea, Republic of
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KOR
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Korea, Republic of
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Incheon
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Mexico
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Ciudad De Mexico
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Mexico
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Ciudad De México
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Mexico
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Guerrero
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Mexico
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Jalisco
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Mexico
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MEX
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Mexico
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Nuevo Leon
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Mexico
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Oaxaca
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Mexico
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Yucatan
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Mexico
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Aguascalientes
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Mexico
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Chihuahua
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Poland
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LD
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Poland
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SL
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Poland
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Wroclaw
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Puerto Rico
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San Juan
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Spain
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ESP
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Pontevedra
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Spain
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Santander
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Spain
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Sevilla
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United Kingdom
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GBR
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United Kingdom
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NGM

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galectin Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pol Boudes, M.D.
Address 0 0
Galectin Therapeutics Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04365868