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    Summary
    EudraCT Number:2015-000181-60
    Sponsor's Protocol Code Number:GIFT-02
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-02-14
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-000181-60
    A.3Full title of the trial
    A Multi-Center, Randomized, Double-Blind, Three-Arm, Parallel-Group trial to assess the efficacy and safety of NTRA-9620 in infants with Short Bowel Syndrome (SBS) following surgical resection.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy Study in Infants With SBS
    A.3.2Name or abbreviated title of the trial where available
    GIFT-02
    A.4.1Sponsor's protocol code numberGIFT-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02865122
    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 SponsorNutrinia Ltd.
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNutrinia Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSermes UK Limited
    B.5.2Functional name of contact pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street Address1 Paper Mews, 330 High Street, Dorking
    B.5.3.2Town/ citySurrey
    B.5.3.3Post codeRH4 2TU
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailignazio@sermesuk.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1532
    D.3 Description of the IMP
    D.3.2Product code NTRA-9620-A
    D.3.4Pharmaceutical form Oral powder in sachet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.2Current sponsor codeNTRA-9620-A
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/g international unit(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 2
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/15/1532
    D.3 Description of the IMP
    D.3.2Product code NTRA-9620-B
    D.3.4Pharmaceutical form Oral powder in sachet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.2Current sponsor codeNTRA-9620-B
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/g international unit(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboOral powder in sachet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Short Bowel syndrome
    E.1.1.1Medical condition in easily understood language
    Short Bowel Syndrome
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10025479
    E.1.2Term Malabsorption syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10025476
    E.1.2Term Malabsorption
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy and safety of NTRA-9620 compared with placebo when added to standard of care (SOC) in pediatric subjects (aged 28 weeks post-menstrual age to 52 weeks chronological age) with SBS within 4 months from surgical resection who are on parenteral nutrition (PN) support.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria to be included:
    1) Subject must be at least 28 weeks post-menstrual age and up to 52 weeks chronological age at enrollment.
    2) Subject weight must be at least 500 grams (17.6 ounces) at time of enrollment.
    3) Clinically diagnosed with SBS requiring PN/IV secondary to surgical resection of the intestine.
    4) After major surgical resection leading to SBS, the subject has maximally 70% of expected bowel length preserved or an ostomy in place such that ≤ 70% of the small bowel is available for absorption .
    5) Subject can tolerate at least 10 mL/kg/day of enteral nutrition (EN) for at least 7 days at time of enrollment.
    6) At time of enrollment subject is on at least 70% of prescribed PN/IV and no more than 30% of EN based on total caloric intake for at least 7 days prior to study entry.
    7) Subject is randomized into the trial within 4 months from the surgical resection that has led to the diagnosis of SBS.
    8) Subject’s parent(s) or legal guardian(s) provide written informed consent.
    9) Subject’s parent(s) or legal guardian(s) understand and are willing to comply with all study procedures and requirements.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria at study entry will be excluded:
    1) Subject has undergone any bowel lengthening procedure.
    2) Subject has a malabsorption disorder such as:
    • Congenital etiology (such as microvilli inclusion disease, tufting enteropathy)
    • Untreated Hirchsprung’s disease
    3) Significant motility disorder such as:
    • Pseudo obstruction
    • Severe gastroschisis defined as: primary reason for PN support is due to persistent feeding intolerance of less than 20 ml/kg/day EN intake or signs and symptoms (i.e., abdominal distention, vomiting) requiring prokinetic agents.
    4) Any known inherited abnormality (e.g., Fanconi syndrome,) that is not related to SBS.
    5) Prior bowel resection due to isolated spontaneous intestinal perforation.
    6) < 10 cm of remaining small bowel left with no colon.
    7) Uncontrolled systemic infection, acute gastroenteritis, pneumonia, cardiovascular or other abnormality including EKG findings that in the opinion of the investigator makes the infant unstable and at significant risk of not completing the first 12 weeks of the study.
    8) Subjects with known hyperinsulinemia .
    9) Subjects with unexplained or recurrent hypoglycemia with blood glucose ≤ 50 mg/dL within 48 hours of treatment initiation.
    10) Subjects with severe anemia of Hemoglobin less than 60 g/L and requiring transfusion within 48 hours of treatment initiation to avoid a life threatening event.
    11) Subjects who require pancreatic enzyme replacement therapy.
    12) Subject is currently receiving oral or injectable insulin for any reason.
    13) Participation in another interventional clinical study within the past 30 days that may interfere with the results of this study.
    14) History or current use of growth factors or glutamine.
    15) In the opinion of the investigator, the subject has any other medical condition that would make participation in this study either unsafe or would compromise the potential benefit of insulin treatment
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are the percent changes in %PN (PC_PN0-t) from baseline based on caloric intake to 12 weeks and again to 24 weeks.

    E.5.1.1Timepoint(s) of evaluation of this end point
    12 and 24 weeks treatment
    E.5.2Secondary end point(s)
    Key Secondary Endpoint
    Time to reduction of PN to less than 10% of the total caloric intake on 14 consecutive days.

    Other Secondary Endpoints
    a) Time to wean off parenteral nutrition
    b) Number of patients reaching readiness to wean off at 12 and 24 weeks from baseline.
    c) Time to 50% PN/IV reduction from baseline in %PN based on total calories.
    d) Time to 50% PN/IV reduction from baseline in %PN based on volume.
    e) Number of patients reaching 50% PN/IV reduction from baseline in %PN based on total calories at 12 and 24 weeks.
    f) Number of patients reaching 50% PN/IV reduction from baseline in %PN based on volume at 12 and 24 weeks.
    g) Percent change from baseline in %PN/IV based on total calories.
    h) Percent change from baseline in %PN/IV based on volume.
    i) Percent change from baseline in PN/IV fluid volume during treatment period.
    j) Change in Z-scores (Fenton) from baseline during the treatment period
    k) Percent change from baseline in %EN based on total calories.
    l) Percent change from baseline in %EN based on total volume.
    m) Change from baseline in liver enzymes (ALT, GGT, and total and direct bilirubin).
    n) Change from baseline in plasma citrulline levels.
    o) Change from baseline in body weight during the treatment period.
    p) Weekly average of hours on prescribed PN/IV during the last month of treatment.
    q) General safety variables including episodes of significant feeding intolerance
    compared to placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key secondary endpoint at 12 weeks or 24 weeks.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Canada
    Croatia
    Finland
    France
    Germany
    Israel
    Netherlands
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 150
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 150
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The subjects are infants less than one year old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 150
    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)
    The trial treatment ends after 24 weeks of treatment. Follow-up is planned up to 104 weeks after start treatment.
    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 Decision2017-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-07
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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