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    Summary
    EudraCT Number:2022-004195-42
    Sponsor's Protocol Code Number:FIT-05
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2022-004195-42
    A.3Full title of the trial
    A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest
    Estudio en cesta multicéntrico, aleatorizado, doble ciego, de dos grupos paralelos y controlado con placebo para evaluar la seguridad de ELGN-2112 en poblaciones de interés.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study that will be conduced in different clinical sites, in which nor the
    patient neither the doctors will know the treatment given to patient, with 2
    different group in which the patients will be assigned randomly, controlled
    with respect to placebo, that has the aim to estabilish the
    safety of ELGN2112 on the incapability of preterm baby to absorb sufficient
    nutrients, a condition known as intestinal malabsorption
    Estudio que se llevará a cabo en diferentes centros clínicos, en el que ni el paciente ni los médicos conocerán el tratamiento administrado al paciente, con 2 grupos diferentes en los que los pacientes serán asignados aleatoriamente, controlados con respecto a placebo, que tiene el objetivo de establecer la seguridad de ELGN2112 sobre la incapacidad del bebé prematuro para absorber suficientes nutrientes, una condición conocida como malabsorción intestinal.
    A.3.2Name or abbreviated title of the trial where available
    FIT-05
    A.4.1Sponsor's protocol code numberFIT-05
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/079/2018
    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 organisationFravil Clinical Consulting
    B.5.2Functional name of contact pointGisela Hellgren
    B.5.3 Address:
    B.5.3.1Street AddressBohusgatan 41
    B.5.3.2Town/ citySTOCKHOLM
    B.5.3.3Post code116 67
    B.5.3.4CountrySweden
    B.5.4Telephone number+46703340151
    B.5.6E-mailgisela.hellgren@fravil.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.3.4Pharmaceutical 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 codeELGN-2112
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    Malabsorción intestinal en niños prematuros.
    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.
    El tracto digestivo (esófago, estómago e intestinos) de los bebés prematuros no está completamente desarrollado y son incapaces de absorber nutrientes, lo que se describe como malabsorción intestinal.
    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 10032405
    E.1.2Term Other preterm infants
    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 10032414
    E.1.2Term Other preterm infants, less than 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 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 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 10076729
    E.1.2Term Very preterm infant
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084217
    E.1.2Term Extremely preterm (less than 28 weeks)
    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 compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile* born at 26-32 weeks GA.
    * According to Fenton preterm growth chart
    Comparar la seguridad del tratamiento con ELGN-2112 con la del placebo en lactantes prematuros nacidos con menos de 26 semanas de EG y en lactantes con RCIU por debajo del percentil 3* nacidos con 26-32 semanas de EG.
    *Según la gráfica de crecimiento de Fenton para prematuros.
    E.2.2Secondary objectives of the trial
    The efficacy of treatment with ELGN-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding Assess the Effect of ELGN-2112 on the following; ELGN-2112 compared to placebo on No of days until full wean off PN; Incidence and severity of NEC (Incidence of modified Bell’s stage grade ≥2a of NEC in the entire study population. Distribution of severity of NEC according to modified Bell’s staging in infants who experienced NEC in the entire study population); On % of infants with culture proven nosocomial sepsis; On % of infants experiencing 1 of the AE of relevance(NEC,Infection,Death); On No of days to 120 ml/kg/day for 3 consecutive days; On No of days until PN wean off; On % enteral/ parenteral feedings from total nutrition over time; On No of days to discharge from primary hospital; ELGN-2112 compared to placebo on No of days to discharge home; Anthropometrics ; ROP at 30-36 wks PMA.
    Eficacia del tratamiento con ELGN-2112 en comparación con placebo sobre la malabsorción intestinal en lactantes prematuros (tiempo en lograr la nutrición enteral completa), sobre el nº de días hasta la retirada de la nutrición parenteral (NP), sobre la incidencia y gravedad de la enterocolitis necrosante, sobre el % de lactantes con sepsis nosocomial confirmada por cultivo, sobre el % de lactantes que presenten uno de los acontecimientos adversos de interés, sobre el nº de días hasta lograr un consumo de 120 ml/kg/día durante 3 días consecutivos, sobre el nº de días hasta la retirada de la NP, sobre el % de tomas con respecto a la nutrición total a lo largo del tiempo, sobre el nº de días hasta el alta del hospital, sobre el número de días hasta el alta al domicilio, sobre las medidas antropométricas, sobre la puntuación de actividad de la retinopatía del prematuro a las 30-36 semanas de edad posmenstrual .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female preterm infant born less than 26 weeks GA (up to 25+6) or Intra-Uterine Growth Restricted (IUGR) infants (below 3rd percentile), born between 26+0 to 31+6 GA. *Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound
    2. Birth weight ≥ 450g
    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 feeds
    8. Infant is expected to wean off parenteral nutrition (PN) at the primary hospital
    9. Informed consent form signed by parents or legal guardian
    10. In the Investigator’s opinion, the infant is sufficiently stable to partake in the trial to completion
    11. (France only) – only participants benefiting from a health insurance plan can participate in research.
    * If both exist and difference > 2 weeks, based on early antenatal ultrasound
    1. Lactante prematuro de cualquier sexo nacido con menos de 26 semanas de EG (hasta 25+6) o lactante con RCIU (por debajo del percentil 3), nacido entre los días 26+0 y 31+6 de EG. *Concordancia en la EG (±2 semanas) entre las fechas maternas o la ecografía prenatal inicial.
    2. Peso al nacer ≥450 g.
    3. Parto único o gemelar.
    4. Edad posnatal hasta el quinto día, inclusive (hasta 120 horas después del parto).
    5. Fracción de oxígeno inspirado ≤0,60 en el momento de inclusión en el estudio.
    6. Los lactantes deben mostrar estabilidad cardiovascular en el momento de inclusión en el estudio y se les considerará inestables si precisan apoyo de la presión arterial a través de una vía central.
    7. El lactante tolera la alimentación enteral.
    8. Previsión de que el lactante deje de recibir NP en el hospital principal.
    9. Documento de consentimiento informado firmado por los padres o el tutor.
    10. En opinión del investigador, el lactante se encuentra suficientemente estable para participar en el ensayo hasta su finalización.
    11. (Únicamente en Francia): en la investigación solo puede incluirse a participantes beneficiarios de un plan de seguro médico.
    * Si existen ambas y la diferencia es mayor de 2 semanas, se tomará como base la ecografía prenatal inicial.
    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. For infants born under 26 weeks GA, Intra-uterine growth restriction (IUGR) defined as weight for gestational age less than the third percentile according to Fenton preterm growth chart .
    5. Confirmed necrotizing enterocolitis (NEC)
    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. Nothing per os (NPO) at study entry and enteral/oral supplements are not allowed
    10. Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins.
    11. Participation in another interventional clinical study that may interfere with the primary and secondary outcomes of this trial
    1. El lactante consume más de 100 ml/kg/día por vía enteral al incorporarse al estudio.
    2. El lactante no muestra dependencia de aminoácidos o lípidos parenterales como forma de nutrición.
    3. Malformación congénita importante (p. ej., lactantes con trastorno genético, metabólico o endocrino diagnosticado antes de la inclusión en el estudio).
    4. En los lactantes nacidos con menos de 26 semanas de EG, RCIU definida como un peso para la edad gestacional inferior al percentil 3 según la gráfica de crecimiento de Fenton para prematuros (véase el Apéndice D).
    5. Enterocolitis necrosante confirmada.
    6. Diabetes materna (tipo 1/2 o gravídica) con necesidad de insulina durante el embarazo o en madres con antecedentes médicos.
    7. Sospecha o confirmación de hiperinsulinemia con necesidad de administración de más de 12 mg/kg/min de glucosa en el momento de la aleatorización.
    8. Administración de cualquier insulina sistémica en el momento de la aleatorización.
    9. No se permite la dieta absoluta en el momento de incorporación al estudio ni los suplementos enterales u orales.
    10. Sujetos con riesgo de complicaciones gastrointestinales importantes, como síndrome de transfusión fetofetal (STFF) o gemelos monoamnióticos monocoriónicos.
    11. Participación en otro estudio clínico intervencionista que pueda interferir en los criterios de valoración principal y secundarios de este ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Safety of ELGN-2112 as compared to placebo in preterm infants born under 26 weeks GA and IUGR infants born between 26-32 weeks GA.
    Seguridad de ELGN-2112 en comparación con placebo en lactantes prematuros nacidos con menos de 26 semanas de EG y en lactantes con RCIU nacidos con entre 26 y 32 semanas de EG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the study
    Durante el estudio.
    E.5.2Secondary end point(s)
    1. Number 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.
    2. Number of days until wean off PN (total cessation)
    3. Incidence and severity of Necrotizing Enterocolitis (NEC)
    a. Incidence of modified Bell’s stage grade ≥2a of NEC in the entire study population.
    b. Distribution of severity of NEC according to modified Bell’s staging in infants who experienced NEC in the entire study population.
    4. Number of events of culture proven nosocomial Sepsis
    5. Percentage of subjects experiencing one of the adverse events of relevance (NEC, Infections, Death)
    6. Number of days to 120 ml/kg/day for three consecutive days
    7. Number of days until PN wean off (time to amino acids and lipids withdrawal)
    8. Percent enteral/ parenteral feedings from total nutrition over time
    9. Number of days to discharge from primary hospital.
    10. Number of days from randomization to discharge home.
    11. Anthropometrics
    12. Retinopathy of prematurity (ROP) activity score at 30-36 weeks PMA
    1. Número de días hasta lograr la nutrición enteral completa, definido como el primero de tres días consecutivos con capacidad del lactante para lograr una alimentación enteral mínima de 150 ml/kg al día.
    2. Número de días hasta la retirada (cese total) de la NP.
    3. Incidencia y gravedad de la enterocolitis necrosante (ECN).
    a. Incidencia de ECN en estadio de Bell modificado ≥2a en la población completa del estudio.
    b. Distribución de la gravedad de la ECN según los estadios de Bell modificados en los lactantes que presenten ECN en la población completa del estudio.
    4. Número de episodios de sepsis nosocomial confirmada por cultivo.
    5. Porcentaje de sujetos que presenten uno de los acontecimientos adversos de interés (ECN, infecciones o muerte).
    6. Número de días hasta lograr un consumo de 120 ml/kg/día durante tres días consecutivos.
    7. Número de días hasta la retirada de la NP (tiempo hasta la retirada de aminoácidos y lípidos).
    8. Porcentaje de tomas enterales/parenterales respecto a la nutrición total a lo largo del tiempo.
    9. Número de días hasta el alta del hospital principal.
    10. Número de días transcurrido desde la aleatorización hasta el alta al domicilio.
    11. Medidas antropométricas.
    12. Puntuación de actividad de la retinopatía del prematuro (RP) a las 30-36 semanas de EPM.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the study
    Durante el estudio.
    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) No
    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 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 EEA18
    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
    Sweden
    Netherlands
    Spain
    Italy
    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
    LVLP
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 60
    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: 60
    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.1.3Elderly (>=65 years) No
    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 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
    Newborn infants
    Recién nacidos.
    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 45
    F.4.2.2In the whole clinical trial 60
    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 clinic for follow-up visist at 3, 12 and 24 month of corrected age
    Período de seguimiento; los lactantes volverán a la clínica para una visita de seguimiento a los 3, 12 y 24 meses de edad corregida.
    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 Decision2023-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-14
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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