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    Summary
    EudraCT Number:2020-002726-84
    Sponsor's Protocol Code Number:SHP607-203
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-09-11
    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 ConcernedUK - MHRA
    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
    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
    A.3.2Name or abbreviated title of the trial where available
    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
    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 number1781869 7537
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Lung Disease
    E.1.1.1Medical condition in easily understood language
    Chronic Lung Disease
    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 LLT
    E.1.2Classification code 10066204
    E.1.2Term Chronic lung disease of prematurity
    E.1.2System Organ Class 100000004855
    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.
    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
    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).
    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 follow-up as determined by the investigator.
    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
    E.5.1.1Timepoint(s) of evaluation of this end point
    throughout the study
    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 attention-deficit/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.
    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) .
    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 Yes
    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
    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.8.3 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 concerned8
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Finland
    Germany
    Israel
    Italy
    Japan
    Portugal
    Spain
    Sweden
    United Kingdom
    United States
    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
    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.1.1Number of subjects for this age range: 382
    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.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state63
    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.
    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 Decision2020-09-08
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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