Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-002624-28
    Sponsor's Protocol Code Number:FIT-04
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-04
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-002624-28
    A.3Full title of the trial
    A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in preterm infants.
    Studio multicentrico, in doppio cieco, randomizzato, a tre bracci di trattamento, a gruppi paralleli, controllato verso placebo per valutare l'efficacia e la sicurezza di NTRA-2112 sul malassorbimento intestinale in neonati pre-termine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To assess the efficacy of 2 doses of NTRA-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding.
    Valutare l¿efficacia di due dosi di NTRA-2112 a confronto con il placebo sul malassorbimento intestinale in neonati pre-termine, misurata in termini di tempo richiesto per raggiungere la nutrizione enterale completa.
    A.3.2Name or abbreviated title of the trial where available
    A Study to Assess the Efficacy and Safety of 2 dose levels of NTRA-2112 in Preterm Infants
    Studio per valutare l'efficacia e la sicurezza di 2 dosi di NTRA-2112 in neonati pretermine
    A.4.1Sponsor's protocol code numberFIT-04
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02510560
    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 sponsorCommercial
    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 organisationNutrinia Ltd
    B.5.2Functional name of contact pointClinical Affairs
    B.5.3 Address:
    B.5.3.1Street Address6 Ha-Khilazon Street
    B.5.3.2Town/ cityRamat-Gan
    B.5.3.3Post code5252270
    B.5.3.4CountryIsrael
    B.5.4Telephone number972-3-7262262
    B.5.5Fax number972-3-7262263
    B.5.6E-mailinfo@nutrinia.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 nameinsulina umana
    D.3.2Product code NTRA-2112-1
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNINSULINA UMANA
    D.3.9.1CAS number 11061-68-0
    D.3.9.2Current sponsor codeNTRA-2112-1
    D.3.9.4EV Substance CodeSUB08187MIG
    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
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameinsulina umana
    D.3.2Product code NTRA-2112-2
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNINSULINA UMANA
    D.3.9.1CAS number 11061-68-0
    D.3.9.2Current sponsor codeNTRA-2112-2
    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
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    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 placeboPowder for oral solution
    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
    Gastro Intestinal Malabsorption in Preterm Infants.
    Malassorbimento Intestinale in neonati pretermine
    E.1.1.1Medical condition in easily understood language
    Preterm infants have an under-developed gastrointestinal tract.
    The final Insulin concentration obtained with NTRA-2112 is physiological and within the range present in human breast milk.
    I neonati pretermine hanno un tratto gestrointestinale sottosviluppato.
    La concentrazione finale di insulina ottenuta con NTRA-2112 ¿ fisiologica ed entro il range presente nel latte materno umano.
    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 20.1
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10025479
    E.1.2Term Malabsorption syndrome
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of 2 doses of NTRA-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding.
    Valutare l¿efficacia di due dosi di NTRA-2112 a confronto con il placebo sul malassorbimento intestinale in neonati pre-termine, misurata in termini di tempo richiesto per raggiungere la nutrizione enterale completa.
    E.2.2Secondary objectives of the trial
    To assess the effect of 2 doses of NTRA-2112 compared to placebo on number of days to achieve discharge from hospital or readiness for discharge from hospital, whichever comes first. Readiness for discharge from the hospital is defined as achieving all of the below: ¿
    - Infant weight =1800g ¿
    - Stable body temperature (no external support needed)¿
    - Capable of oral feeding (not through nasogastric or orogastric tube

    To compare 2 doses of NTRA-2112 to placebo with respect to the following:
    1. Growth parameters
    2. Number and percentage of infants reaching full enteral feeding within 6, 8, and 10 days from initiation of treatment
    3. Mean enteral feeding (ml/kg) on days 6, 8 and 10 from initiation of treatment

    To compare 2 doses of NTRA-2112 to placebo with respect to the number of days to end gastric residuals over 2ml/measurement
    Valutare l¿effetto di 2 dosi di NTRA-2112 a confronto con il placebo sul n. di giorni impiegati per raggiungere la dimissione dall¿ospedale o il momento in cui il neonato ¿ pronto per essere dimesso, a seconda di quale si verifichi per primo. La ¿readiness for discharge¿ dall¿ospedale ¿ definita dal rispetto di tutti i seguenti criteri:
    ¿ - Peso del neonato = 1800 g
    ¿ - Temperatura corporea stabile (nessun supporto esterno necessario)
    ¿ - Neonato in grado di ricevere nutrizione orale (non tramite tubo nasogastrico o orogastrico)
    Confrontare 2 dosi di NTRA-2112 con il placebo per quanto riguarda:
    1. Parametri di crescita
    2. Numero e percentuale di neonati che raggiungono la nutrizione enterale completa entro 6, 8 e 10 giorni dall¿inizio del trattamento.
    3. Nutrizione enterale media (ml/kg) dopo 6, 8 e 10 giorni dall¿inizio del trattamento.
    Confrontare 2 dosi di NTRA-2112 con il placebo per quanto riguarda il n. di giorni impiegati per esaurire i residui gastrici > 2ml/misurazione
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female pre-term infant 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
    5. Fraction of inspired oxygen = 0.60 at enrolment
    6. The infant is in a cardiovascular stable condition
    7. Infant is able to take enteral feed
    8. Infant is expected to wean off PN at the primary hospital
    9. Informed consent form signed by parents or legal guardian
    10. In the Investigator’s opinion, is able to comply and sufficiently stable to partake in the trial to completion
    * If both exist and difference > 2 weeks, based on early antenatal ultrasound
    1. Neonati pre-termine, maschi e femmine, di età gestazionale compresa tra 26 e 32 settimane (massimo 32 settimane + 0 giorni). Età gestazionale corrispondente (±2 settimane) tra le date materne e/o l’ecografia prenatale precoce*.
    2. Peso alla nascita = 500 g.
    3. Figlio singolo o gemello.
    4. Età post-natale fino a 5 giorni (Giorno 5 incluso).
    5. Frazione di ossigeno inspirato = 0.60 all’arruolamento.
    6. Il neonato è in una condizione cardiovascolare stabile.
    7. Il neonato è in grado di assumere nutrizione enterale.
    8. Neonato per il quale ci si aspetta che la nutrizione parenterale venga sospesa presso il centro di sperimentazione.
    9. Consenso informato firmato dai genitori o da un rappresentante legalmente riconosciuto.
    10. Neonato che, secondo il giudizio dello Sperimentatore, sia in grado di aderire e sia sufficientemente stabile per prendere parte alla Sperimentazione fino al suo completamento.
    * se entrambe sono disponibili e la differenza tra le due è > di 2 settimane, occorre considerare l’ecografia prenatale precoce
    E.4Principal exclusion criteria
    1. Complete enteral feeding
    2. Major congenital malformation (i.e., infants with genetic, metabolic, or endocrine disorder diagnosed before enrolment
    3. High index of suspicion of infection before enrolment
    4. Intra-uterine growth retardation (IUGR) defined as either weight for gestational age less than the third percentile or less than the 10’th percentile with Doppler abnormalities in utero **.
    5. Confirmed necrotizing enterocolitis (NEC)
    6. Maternal diabetes (Type I/II or gestational).
    7. Any systemic insulin administration after birth.
    8. Nothing per os (NPO) for any reason at study entry.
    9. Heart and chest compression or any resuscitation drugs given to the infant during delivery
    10. Participation in another interventional clinical study that may interfere with the results of this trial
    **According to Fenton preterm growth chart
    1. Nutrizione enterale completa.
    2. Malformazione congenita maggiore (es: neonati con disordine genetico, metabolico o endocrino, diagnosticati prima dell’arruolamento).
    3. Alto indice di sospetta infezione prima dell’arruolamento.
    4. Ritardo di crescita intrauterino (IUGR) definito sia come peso per età gestazionale inferiore al terzo percentile o inferiore al decimo percentile con anomalie del Doppler in utero**.
    5. Enterocolite necrotizzante (NEC) confermata.
    6. Diabete materno (tipo I/II o gestazionale).
    7. Qualsiasi somministrazione sistemica di insulina dopo la nascita
    8. Nessuna somministrazione per os (NPO) per nessuna ragione all’ingresso nello studio.
    9. Compressione cardiaca e toracica o qualsiasi farmaco per la rianimazione dato al neonato durante il parto.
    10. Partecipazione ad un altro studio clinico interventistico che possa interferire con i risultati di questa sperimentazione.
    ** in accordo alla curva di crescita di Fenton relativa al pretermine
    E.5 End points
    E.5.1Primary end point(s)
    Numbers of days to achieve full enteral feeding, defined as the ability of the preterm infant to achieve enteral feeding at least 150 ml/kg/day for 3 consecutive days
    Numero di giorni necessari per raggiungere la nutrizione enterale completa, definita come la capacità del neonato pre-termine di raggiungere la nutrizione enterale di almeno 150 ml/kg/giorno per 3 giorni consecutivi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 28 days
    Fino a 28 giorni
    E.5.2Secondary end point(s)
    Number of days to discharge from the hospital or readiness-for-discharge from hospital, whichever occurs first.
    Readiness-for-discharge is defined as meeting all the following criteria: ¿
    -Infant weight = 1800g ¿
    -Stable body temperature ¿
    -Capable of oral feeding (not through nastrogastric or orogastric tube)
    Growth velocity (g/kg/day)
    Gain in body weight during the treatment and follow-up periods
    Reaching full enteral feeding within 6, 8, and 10 days from initiation of treatment
    Mean enteral feeding on days 6, 8, and 10 days from initiation of treatment
    Number of days to end gastric residuals over 2 ml/measurement
    Numero di giorni necessari per raggiungere la dimissione dall¿ospedale o per raggiungere la ¿readiness for discharge¿ dall¿ospedale (intesa come momento in cui il neonato ¿ pronto per essere dimesso), a seconda di quale evento si verifichi per primo.
    La ¿readiness for discharge¿ ¿ definita dal rispetto di tutti i seguenti criteri:
    -Peso del neonato= 1800 g
    -Temperatura corporea stabile*
    -Neonato in grado di ricevere nutrizione orale (non tramite tubo nasogastrico o orogastrico)
    Velocit¿ di crescita (g/kg/giorno)
    Aumento del peso corporeo durante il periodo di trattamento e il periodo di follow-up.
    Raggiungimento della nutrizione enterale completa entro 6, 8 e 10 giorni dall¿inizio del trattamento.
    Nutrizione enterale media (ml/kg) dopo 6, 8 e 10 giorni dall¿inizio del trattamento.
    Numero di giorni impiegati per esaurire i residui gastrici superiori a 2 ml/misurazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 3 months of corrected age
    Fino a 3 mesi di et¿ corretta
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Israel
    Italy
    Netherlands
    Spain
    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
    LVLS
    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.1.1.1In 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: 530
    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
    pre-term infants
    neonati pre-termine
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 530
    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 infant will be brought to the study site for a follow-up visit, at 3 months corrected age (¿14days).
    I bambini verranno portati al centro per una visita di follow-up a 3 mesi di et¿ corretta (¿14 giorni)
    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 Decision2017-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu May 02 09:28:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA