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    Summary
    EudraCT Number:2020-002726-84
    Sponsor's Protocol Code Number:SHP607-203
    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:2021-05-24
    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 number2020-002726-84
    A.3Full title of the trial
    Long-Term Safety and Efficacy Outcomes Following Previously
    Administered Short-Term Treatment with SHP607 in Extremely Premature
    Infants
    Esiti di sicurezza ed efficacia a lungo termine a seguito di trattamento a breve termine precedentemente somministrato con SHP607 in neonati estremamente prematuri
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term follow up study after administration of SHP607 in Extremely
    Premature Infants
    Studio di follow-up a lungo termine dopo la somministrazione di SHP607 a neonati estremamente prematuri
    A.3.2Name or abbreviated title of the trial where available
    Footsteps
    Footsteps
    A.4.1Sponsor's protocol code numberSHP607-203
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/066/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPREMACURE AB, A MEMBER OF SHIRE GROUP OF COMPANIES
    B.1.3.4CountrySweden
    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 supportPremacure AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Pharmaceutical Company Limited
    B.5.2Functional name of contact pointLauren Dinsmore
    B.5.3 Address:
    B.5.3.1Street Address300 Shire Way
    B.5.3.2Town/ cityLexington, MA
    B.5.3.3Post code02421
    B.5.3.4CountryUnited States
    B.5.4Telephone number17818697537
    B.5.6E-maillauren.dinsmore@takeda.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 nameSHP607 (mecasermin rinfabate, rhIGF-1/rhIGFBP-3)
    D.3.2Product code [SHP607]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNMECASERMIN RINFABATE
    D.3.9.1CAS number 478166-15-3
    D.3.9.2Current sponsor codeSHP607, HGT-ROP001
    D.3.9.4EV Substance CodeSUB25205
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameSHP607 (mecasermin rinfabate, rhIGF-1/rhIGFBP-3)
    D.3.2Product code [SHP607]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNmecasermine rinfabate
    D.3.9.1CAS number 478166-15-3
    D.3.9.2Current sponsor codeSHP607, HGT-ROP001
    D.3.9.4EV Substance CodeSUB25205
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Lung Disease
    malattia polmonare cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Lung Disease
    malattia polmonare cronica
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025082
    E.1.2Term Lung disorder
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 long-term efficacy outcomes following previously
    administered short-term exposure to SHP607, as compared to a standard
    neonatal care group, as assessed by chronic respiratory morbidity (CRM)
    outcomes.
    • To evaluate the long-term safety outcomes following previously
    administered short-term exposure to SHP607, as compared to a standard
    neonatal care group.
    Valutare gli esiti di efficacia a lungo termine a seguito di esposizione a breve termine a SHP607 precedentemente somministrato, rispetto a un gruppo con cure neonatali standard, come valutato dagli esiti di morbilità respiratoria cronica (CRM).
    • Valutare gli esiti di sicurezza a lungo termine a seguito di esposizione a breve termine a SHP607 precedentemente somministrato, rispetto a un gruppo con cure neonatali standard.
    E.2.2Secondary objectives of the trial
    To evaluate long-term effects following previously administered short
    term exposure to SHP607 on growth, cognitive and motor development,
    behavior, and resource utilization, as compared to a standard neonatal
    care group, by assessing:
    •Growth parameters
    •Physical development
    •Cognitive development
    •Gross motor function
    •Child behavior
    •Health related quality of life (HRQoL)
    •Health utility
    •Health care resource use
    Valutare gli effetti a lungo termine a seguito di esposizione a breve termine a SHP607 precedentemente somministrato sulla crescita, lo sviluppo cognitivo e motorio, il comportamento e l'utilizzo delle risorse, rispetto a un gruppo con cure neonatali standard, attraverso la valutazione di:
    •Parametri di crescita
    •Sviluppo fisico
    •Sviluppo cognitivo
    •Funzione grosso-motoria
    •Comportamento del bambino
    •Qualità della vita relativa allo stato di salute (HRQoL)
    •Health utility [salute del paziente]
    •Utilizzo delle risorse sanitarie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject was randomized into Study SHP607-202. Subjects who were
    randomized, but did not complete Study SHP607-202 must be at least 12
    months CA.
    2.Written informed consents (and assents, if applicable) must be signed
    and dated by the subject's parent(s)/legally authorized
    representative(s) prior to any study-related procedures. The informed
    consent and any assents for underage parents must be approved by the institutional review board (IRB)/independent ethics committee (IEC).
    1.Il soggetto è stato randomizzato nello studio SHP607-202. I soggetti che sono stati randomizzati, ma non hanno completato lo studio SHP607-202 devono avere almeno 12 mesi CA.
    2.I consensi informati scritti (e gli assensi, se applicabile) devono essere firmati e datati dai genitori/rappresentanti legalmente autorizzati del soggetto prima di qualsiasi procedura relativa allo studio. Il consenso informato ed eventuali assensi per i genitori minorenni devono essere approvati dal Comitato di revisione istituzionale (IRB)/Comitato etico indipendente (CEI)
    E.4Principal exclusion criteria
    Subjects are excluded from the study if the subject or subject's
    parent(s)/legally authorized representative(s) is/are unable to comply
    with the protocol or is/are unlikely to be available for long-term followup as determined by the investigator.
    I soggetti sono esclusi dallo studio se il soggetto o i genitori/rappresentanti legalmente autorizzati non sono in grado di rispettare il protocollo o è improbabile che siano disponibili per il follow-up a lungo termine come stabilito dallo sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints: Incidence of the following indicators of
    chronic respiratory morbidity through 5 years CA:
    1)Emergency room visit or hospitalization associated with a respiratory
    diagnosis.
    2)Presence of coughing/wheezing.
    3)Use of respiratory medications (eg, bronchodilators, steroids,
    leukotriene inhibitors, diuretics).
    4)Home respiratory technology use (eg, home oxygen, continuous
    positive airway pressure [CPAP], tracheostomy).
    Primary Safety Endpoint:
    •AEs reported during the study period of SHP607-203
    Endpoint di efficacia primari:
    Incidenza dei seguenti indicatori di morbilità respiratoria cronica a 5 anni CA:
    1)Visita al pronto soccorso o ricovero associato ad una diagnosi respiratoria.
    2)Presenza di tosse/sibilo.
    3)Utilizzo di farmaci respiratori (ad esempio, broncodilatatori, steroidi, inibitori leucotrienici, diuretici).
    4)Utilizzo di tecnologia respiratoria a domicilio (ad esempio, ossigeno a domicilio, pressione positiva continua delle vie aeree [CPAP], tracheostomia).
    Endpoint di sicurezza primario:
    •Eventi avversi (AE) riportati durante il periodo dello studio SHP607-203
    E.5.1.1Timepoint(s) of evaluation of this end point
    throughout the study
    per tutta la durata dello studio
    E.5.2Secondary end point(s)
    •Growth parameters including body weight, body length (or height), and
    head circumference.
    •Physical development as assessed by standardized, age appropriate
    tools including physical exam, neurological examination for assessment
    of cerebral palsy, and vision assessment. Reports of past vision and
    hearing assessments will also be collected
    •Cognitive development as assessed by the following standardized, age
    appropriate tools:
    -Bayley Scales of Infant and Toddler Development (BSID) (or Kyoto
    Scale of Psychological Development [KSPD])
    -Wechsler Preschool and Primary Scale of Intelligence (WPPSI)
    •Gross motor function as assessed by the Gross Motor Function
    Measure-88 (GMFM-88)
    •Child behavior as assessed by the following:
    - Vineland Adaptive Behavior Scales (VABS)
    - Attention-Deficit/Hyperactivity Disorder Rating Scale fifth edition
    (ADHD RS-V) for the assessment of symptoms of attentiondeficit/hyperactivity disorder
    (ADHD)
    - Social Communication Questionnaire (SCQ) for screening of Autism

    Spectrum Disorder
    (ASD)
    • Health related quality of life will be assessed by the Pediatric Quality

    of Life Inventory (PedsQL™) Scales appropriate for the child's age of

    development with the Total Scale Score and 5 domains within Physical

    Health (Physical Functioning and Physical Symptoms) and Psychosocial

    Health Scores (Emotional, Social, and Cognitive
    Functioning).
    • Health status (eg, health utility) will be measured by the Health

    Utilities Index Mark 2 (HUI2) and Mark 3
    (HUI3).
    • Health care resource use associated with inpatient visits, outpatient

    visits, emergency room visits, and visits to specialists will be
    assessed.
    Secondary Safety
    Endpoints:
    • Targeted medical events occurring during the period of Study
    SHP607-203.
    • Fatal SAEs.
    Parametri di crescita compresi peso corporeo, lunghezza del corpo (o altezza) e circonferenza cranica.
    •Sviluppo fisico come valutato tramite strumenti standardizzati e appropriati per l’età, tra cui esame obiettivo, esame neurologico per la valutazione di paralisi cerebrale e valutazione della vista.
    Saranno raccolti anche i referti delle valutazioni visive e uditive precedenti
    •Sviluppo cognitivo come valutato tramite i seguenti strumenti standardizzati e appropriati per l’età:
    -Bayley Scales of Infant and Toddler Development (BSID, Scale Bayley dello sviluppo infantile) (o Kyoto Scale of Psychological Development [KSPD, Scala Kyoto dello sviluppo psicologico])
    -Scala primaria di intelligenza per i bambini in età prescolare di Wechsler (WPPSI)
    •Funzione grosso motoria come valutata dalla Gross Motor Function Measure-88 (GMFM-88, Scala di misurazione della funzione grosso-motoria a 88 voci)
    •Comportamento del bambino come valutato tramite:
    -¿Vineland Adaptive Behavioral Scale (VABS, Scale Vineland del comportamento adattivo)
    -¿Attention-Deficit/Hyperactivity Disorder Rating Scale-fifth edition (ADHD RS-V, Scala di valutazione del disturbo da deficit di attenzione/iperattività quinta edizione) per la valutazione dei sintomi del disturbo da deficit di attenzione/iperattività (ADHD)
    -¿Social Communication Questionnaire (SCQ, Questionario di comunicazione sociale) per lo screening dei disturbi dello spettro autistico (ASD)
    •¿La qualità della vita associata alla salute verrà valutata tramite le Pediatric Quality of Life Inventory Scales (PedsQL™, Scale del questionario sulla qualità della vita in età pediatrica) appropriate per l'età di sviluppo del bambino con un punteggio totale e 5 domini per i punteggi di salute fisica (funzioni fisiche e sintomi fisici) e salute psicosociale (rispettivamente, funzioni emotive, sociali e cognitive)
    •¿Lo stato di salute (ad esempio health utility) verrà misurato mediante il sistema di classificazione dello stato di salute prescolare (HSCS-PS) e Health Utilities Index Mark 2 HUI2) e Mark 3 (HUI3).
    •¿Verrà valutato l'utilizzo delle risorse sanitarie associato alle visite in regime di ricovero sopedaliero, alle visite in regime ambulatoriale, agli accessi al pronto soccorso e alle visite con specialisti.
    Endpoint di sicurezza secondari:
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout the study at the following time points in CA:
    18 months (±6 weeks), 24 months (±6 weeks), 3 years (±6 weeks), 3.5
    years (±6 weeks), 4y (±6 weeks), 4.5 years (±6 weeks) and 5 years (±6
    weeks) .
    per tutta la durata dello studio nei seguenti punti temporali in CA:
    18 mesi (±6 settimane), 24 mesi (±6 settimane), 3 anni (±6 settimane), 3,5 anni (±6 settimane), 4anni (±6 settimane), 4,5 anni (±6 settimane) e 5 anni (±6 settimane) .
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    long term follow up
    long term follow up
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA34
    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
    Canada
    Israel
    Japan
    United States
    Finland
    Germany
    Italy
    Portugal
    Spain
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months8
    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) 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: 382
    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
    The participants will be infants born prematurely and administrated
    with short treatment in previous study, followed 12 months and then
    enrolled into this study for long follow up. Consent will be sought from
    the parents or legal guardian.
    I partecipanti saranno neonati nati prematuri e che hanno ricevuto un breve trattamento nello studio precedente, sono stati seguiti per 12 mesi e poi sono stati arruolati a questo studio per un follow up a lungo termine. Il consenso sarà richiesto ai
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state84
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 209
    F.4.2.2In the whole clinical trial 382
    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)
    No aftercare is planned for this study.
    Non è programmata alcuna assistenza successiva per questo studio.
    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 Decision2020-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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