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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-004890-29
    Sponsor's Protocol Code Number:FIT-PIV
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-04-24
    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 ConcernedAustria - BASG
    A.2EudraCT number2021-004890-29
    A.3Full title of the trial
    A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
    Eine multizentrische, doppelblinde, randomisierte, zweiarmige, Placebo-kontrollierte Parallelgruppen- Studie zur Bewertung der Wirksamkeit und Sicherheit von ELGN-2112 auf die intestinale Malabsorption bei Frühgeborenen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to evaluate if ELGN-2112 is effective and safe for the treatment of Intestinal Malabsorption in Preterm Infants
    Eine Forschungsstudie zur Bewertung ob ELGN-2112 für die Behandlung der Malabsorption im Darm bei Frühgeborenen wirksam und sicher ist
    A.3.2Name or abbreviated title of the trial where available
    FIT-PIV
    FIT-PIV
    A.4.1Sponsor's protocol code numberFIT-PIV
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/458/2022
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorELGAN Pharma
    B.1.3.4CountryIsrael
    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 supportELGAN Pharma
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationELGAN Pharma
    B.5.2Functional name of contact pointMiki Olshansky
    B.5.3 Address:
    B.5.3.1Street Address13 Wadi El Haj 13
    B.5.3.2Town/ cityNazareth
    B.5.3.3Post code17111
    B.5.3.4CountryIsrael
    B.5.4Telephone number097246098626
    B.5.6E-mailmiki@elganpharma.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 nameELGN-2112
    D.3.2Product code ELGN-2112
    D.3.4Pharmaceutical form Powder and solvent for oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    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 codeNA
    D.3.9.3Other descriptive namePh.Eur: Insulin, Human, USP: Insulin Human
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    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 placeboPowder for oral solution
    D.8.4Route of administration of the placeboEnteral use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Intestinal Malabsorption in Preterm Infants
    E.1.1.1Medical condition in easily understood language
    Digestive tract (oesophagus, stomach and intestines)in preterm infants is not fully developed. These infants are unable to absorb sufficient nutrients, which is described as intestinal malabsorption.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032413
    E.1.2Term Other preterm infants, 750-999 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032407
    E.1.2Term Other preterm infants, 1,250-1,499 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032409
    E.1.2Term Other preterm infants, 1,750-1,999 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032411
    E.1.2Term Other preterm infants, 2,500+ grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032415
    E.1.2Term Other preterm infants, unspecified {weight}
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032412
    E.1.2Term Other preterm infants, 500-749 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032406
    E.1.2Term Other preterm infants, 1,000-1,249 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032408
    E.1.2Term Other preterm infants, 1,500-1,749 grams
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032410
    E.1.2Term Other preterm infants, 2,000-2,499 grams
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of ELGN-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding.
    E.2.2Secondary objectives of the trial
    1. effect of ELGN-2112 compared to placebo on number of days until full wean off PN.2.effect of ELGN-2112 compared to placebo on the n of days to discharge home;To compare ELGN-2112 to placebo with respect to the following:3. Incidence and severity of NEC in infants born at 26-28 GAM;4. %of infants reaching full enteral feeding within 6, 8, and 10 days from initiation of treatment;5. N of days to 120 ml/kg/day for 3consecutive days;6. Number of days until PN wean off(time to amino acids and lipids withdrawal);7. %of infants weaned off PN within 4, 6, and 8 days from initiation of treatment;8. % enteral/ parenteral feedings from total nutrition over time;9. N of days to discharge from primary hospital;10. Anthropometrics;11. % of infants with culture proven nosocomial sepsis;12. %of infants experiencing one of the adverse events of relevance (NEC, Infections, Death);13.ROP activity score at 30-36 weeks PMA; To compare the safety of treatment of ELGN-2112 to placebo in preterm infants.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female pre-term infants 26 and up to 32 weeks gestation (32 weeks + 0 day maximum). Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound*.
    2. Birth weight ≥ 500g.
    3. Singleton, or twin birth.
    4. Postnatal age up through and including Day 5 (up to 120 hours post birth).
    5. Fraction of inspired oxygen ≤ 0.60 at enrolment.
    6. Infants must demonstrate cardiovascular stability at time of enrolment and would be considered unstable if they require blood pressure support via a central line.
    7. Infant is able to tolerate enteral feed.
    8. Infant is expected to wean off PN at the primary hospital.
    9. Informed consent form (ICF) signed by parents or legal guardian.
    10. In the Investigator’s opinion, the infant is able to comply with the study procedures and sufficiently stable to partake in the trial to completion.
    * If both exist and difference > 2 weeks, based on early antenatal ultrasound
    E.4Principal exclusion criteria
    1. Infant is consuming more than 100 ml/kg/day enterally at study entry
    2. Infant is not dependent on any parenteral amino acids/lipids as nutrition
    3. Major congenital malformation (e.g., Infants with genetic, metabolic, and/or endocrine disorder diagnosed before enrolment).
    4. Intra-uterine growth restriction (IUGR) defined as weight for gestational age less than the third percentile according to Fenton preterm growth chart (see Appendix D).
    5. Confirmed necrotizing enterocolitis (NEC).1
    6. Maternal diabetes (Type I/II or gestational) requiring insulin during pregnancy or in mothers past medical history.
    7. suspected or confirmed Hyperinsulinemia requiring glucose administration of more than 12 mg/kg/min at randomization.
    8. Any systemic insulin administration at randomization.
    9. Never anything per os (NPO) until 120 hrs post-birth for any reason.
    10. Heart and chest compression or any resuscitation drugs given to the infant during delivery.
    11. Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins.
    12. Participation in another interventional clinical study that may interfere with the primary and secondary outcomes of this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Numbers of days to achieve full enteral feeding, defined as the first day of ability of the preterm infant to achieve enteral feeding of at least 150 ml/kg/day for three consecutive days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the study (first day of ability of the preterm infant to achieve enteral feeding of at least 150 ml/kg/day for three consecutive days)
    E.5.2Secondary end point(s)
    1. Number of days until wean off PN (total cessation)
    2. Number of days from randomization to discharge home
    3. Incidence and severity of Necrotizing Enterocolitis (NEC)
    o Incidence of modified Bell’s stage grade >=2 of Necrotizing Enterocolitis (NEC) in infants born at 26-28 weeks GA.
    o Distribution of severity of Necrotizing Enterocolitis (NEC) according to modified Bell’s staging in infants born at 26-28 weeks GA who experienced NEC.
    o Incidence of modified Bell’s stage grade >=2 of Necrotizing Enterocolitis (NEC) in the entire study population.
    o Distribution of severity of Necrotizing Enterocolitis (NEC) according to modified Bell’s staging in infants who experienced NEC in the entire study population.
    4. Percentage of infants reaching full enteral feeding within 6, 8, and 10 days from initiation of treatment.
    5. Number of days to 120 ml/kg/day for three consecutive days
    6. Number of days until PN wean off (time to amino acids and lipids withdrawal)
    7. Percentage of infants weaned off PN within 4, 6, and 8 days from initiation of treatment
    8. Percent enteral/ parenteral feedings from total nutrition over time
    9. Number of days to discharge from primary hospital.
    10. Anthropometrics
    11. Number of events of culture proven nosocomial Sepsis
    12. Percentage of subjects experiencing one of the adverse events of relevance (NEC, Infections, Death)
    13. Retinopathy of prematurity (ROP) activity score (Appendix ) at 30-36 weeks PMA
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the study (first day of ability of the preterm infant to achieve
    enteral feeding of at least 150 ml/kg/day for three consecutive days)
    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) No
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Israel
    United States
    Austria
    France
    Italy
    Netherlands
    Spain
    Sweden
    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
    LVLS
    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 Yes
    F.1.1Number of subjects for this age range: 360
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 360
    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) 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 Yes
    F.3.3Specific vulnerable populations No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 360
    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)
    Follow up period
    The infants will return to the clinical site for a follow-up visit at 3 -6 months, 12 months, and 24 months corrected age.
    Periodo di follow-up
    I bambini torneranno al centro clinico per una visita di follow-up a 3-6 mesi, 12 mesi e 24 mesi di età corretta.
    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 Decision2023-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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