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    Summary
    EudraCT Number:2019-001983-31
    Sponsor's Protocol Code Number:GT-031
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-08-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2019-001983-31
    A.3Full title of the trial
    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.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis.
    A.3.2Name or abbreviated title of the trial where available
    NAVIGATE
    A.4.1Sponsor's protocol code numberGT-031
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGalectin Therapeutics Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGalectin Therapeutics Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalectin Therapeutics Inc.
    B.5.2Functional name of contact pointSteve Schoenfeld
    B.5.3 Address:
    B.5.3.1Street Address4960 Peachtree Industrial Boulevard; Suite 240
    B.5.3.2Town/ cityNorcross, Georgia
    B.5.3.3Post code30071
    B.5.3.4CountryUnited States
    B.5.6E-mailschoenfeld@galectintherapeutics.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBelapectin
    D.3.2Product code GR-MD-02
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN.A.
    D.3.9.1CAS number 1980787-47-0
    D.3.9.2Current sponsor codeGR-MD-02
    D.3.9.3Other descriptive nameGalactoarabino-rhamnogalacturonate
    D.3.9.4EV Substance CodeSUB204211
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Esophageal Varices in NASH Cirrhosis
    E.1.1.1Medical condition in easily understood language
    Varices (enlarged veins) in oesophagus (muscular tube connecting the throat with the stomach) in patients with liver cirrhosis (scarring) due to non-alcoholic fatty liver disease with inflammation.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009214
    E.1.2Term Cirrhosis of liver without mention of alcohol
    E.1.2System Organ Class 100000004871
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10055489
    E.1.2Term Esophageal varices in cirrhosis of liver
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of 2 mg/kg and 4 mg/kg lean body mass (LBM) of belapectin (GR MD 02) compared to placebo in preventing the development of esophageal varices.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of belapectin on composite clinical outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female, ≥ 18 and ≤ 75 years old.
    2.Willing and able to provide written informed consent.
    3.Has evidence of portal hypertension, with either one:
    a.platelet count <150K/mm3 (from central laboratory or historical record, e.g. detailed chart notes providing platelet numbers or copies of laboratory reports showing platelet count[s] below 150K/mm3)
    OR
    b. documented HVPG measurement >6 mmHg
    OR
    c. at least two of the following:
    -spleen size ≥ 14 cm
    -abdominal collateral circulation
    -documented liver transient elastography ≥20 kPa
    -AST / ALT >1
    4.History confirming NASH cirrhosis, with at least one:
    •Historical liver biopsy showing cirrhosis with steatohepatitis (if slides or blocks are not available, the biopsy report must clearly indicate cirrhosis with steatohepatitis).
    •Historical liver biopsy showing steatohepatitis (if slides or blocks are not available, the biopsy report must clearly indicate 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 or history of 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 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 NAFLD.
    •Historical liver biopsy showing cirrhosis with steatosis but not steatohepatitis (if slides or blocks are not available, the biopsy report must clearly indicate cirrhosis with steatosis).
    •Historical liver biopsy showing steatosis (if slides or blocks are not available, the biopsy report must clearly indicate steatosis) but now with cirrhosis either by physical 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.
    5.Absence of HCC by valid imaging within 6 months prior to randomization.
    6.Patients with diabetes mellitus can be enrolled, if they are adequately controlled on a stable antidiabetic medication(s) for at least 3 months before Screening, and their screening HbA1c is ≤9.5%.
    7.Patients on therapeutic doses of vitamin E or pioglitazone can be enrolled if they are on a stable regimen for at least 3 months before screening, and the regimen 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 effective means of contraception (ie, 2 effective methods of contraception, one of which must be a physical barrier method).
    11. Lactating woman: agrees to discontinue nursing before the start of study treatment and refrain from nursing 90 days after the last dose of study treatment.
    12.Man: agrees to refrain from sperm donation throughout the study period and 90 days following the last dose of investigational medicinal product (IMP). Female: may not begin a cycle of ova donation or harvest throughout the study period and 90 days following the last dose of IMP.
    E.4Principal exclusion criteria
    1.Presence of esophageal, gastroesophageal, or isolated gastric varices, based on an upper GI 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, as per medical history. 4. Alcohol dependence.
    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 ALT > 5 × upper limit of normal (ULN)
    •serum AST > 5 × ULN
    •serum ALP > 2 × ULN
    •mean platelet count < 150,000/mm3
    •albumin ≤ 3.5 g/dL
    •INR ≥1.5 (without anticoagulant therapy)
    •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)
    •MELD score >12 (patients on warfarin will be exempt from this criterion)
    •CTP Score ≥7
    •estimated creatinine clearance < 45 mL/min
    10.Taking an angiotensin converting enzyme inhibitor, angiotensin II receptor blocker, or β-1 selective adrenergic receptor inhibitor, unless on a stable regimen for at least 3 months prior to Screening, and no changes in the regimen are anticipated during the study. Subjects taking a non-selective beta blocker are not eligible to be enrolled (Investigators are encouraged to substitute another medication, if clinically warranted).
    11.History of major surgery during the 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. Positive marijuana/cannabinoids (THC) usage is not an automatic exclusion but rather should be based upon local requirements where applicable.
    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.
    Please refer to the protocol for full details.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients in the belapectin treatment
    groups who develop esophageal varices at
    78 weeks (18 months) of treatment compared to
    placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 2b-Phase 3
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoint
    Incidence rate of patients in the belapectin
    treatment groups, compared to placebo, who
    develop any of the following: 1) varices
    (esophageal or gastric) requiring treatment,
    2) variceal bleed requiring hospitalization,
    3) clinically significant ascites requiring
    hospitalization, 4) spontaneous bacterial
    peritonitis, 5) overt hepatic encephalopathy (West
    Haven score ≥2 and requiring hospitalization),
    6) mortality (all-cause), 7) liver transplant,
    8) model for end-stage liver disease (MELD) score
    ≥15
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 2b-Phase 3
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Seamless, Adaptive
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Chile
    Australia
    Belgium
    Brazil
    Canada
    France
    Germany
    Israel
    Korea, Republic of
    Mexico
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 316
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 79
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 395
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-19
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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