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    Summary
    EudraCT Number:2018-001393-16
    Sponsor's Protocol Code Number:SHP607-202
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-001393-16
    A.3Full title of the trial
    A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Compared to Standard Neonatal Care in Extremely Premature Infants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the safety and efficacy of an experimental drug for chronic lung disease against normally prescribed care in extremely premature babies
    A.4.1Sponsor's protocol code numberSHP607-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03253263
    A.5.4Other Identifiers
    Name:IND numberNumber:133076
    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 organisationShire
    B.5.2Functional name of contact pointCharlotte Almeida
    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 number1781482-6753
    B.5.6E-mailcharlotte.almeida@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.3.10 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.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 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.3.10 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
    The primary objective of this study is to assess the effect of SHP607 on reducing the burden of chronic lung disease (CLD), as indicated by a reduction in time to final weaning off respiratory technology support (RTS) through 12 months corrected age (CA), as compared to a standard neonatal care group.
    E.2.2Secondary objectives of the trial
    The key secondary objective of this study is to assess the effect of SHP607 on the incidence of bronchopulmonary dysplasia (BPD) PMA 36 weeks (defined by modified NICHD severity grading) or death, as compared to a standard neonatal care group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consents must be signed and dated by the subject's parent(s), if age 16 or older, prior to any study-related procedures. For parent(s) under the age of 16, written informed consents and assents must be signed and dated by the subject's parent(s) or legally authorized representative(s), if applicable, 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).
    2. Written informed consents must be signed and dated by the subject's birth mother, if age 16 or older, prior to any study-related procedures. For birth mothers under the age of 16, written informed consents and assents must be signed and dated by the subject's birth mother and her legally authorized representative(s), if applicable, prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the subject. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC.
    3. Initially, subjects must be between GA of 26 weeks +0 days and 27 weeks +6 days, inclusive. After approximately 75 subjects (approximately 25 subjects in each treatment group) have completed the PMA 40 weeks visit, an independent DMC will assess safety data and may authorize enrollment of subjects of GA between 23 weeks +0 days and 27 weeks +6 days, inclusive.
    E.4Principal exclusion criteria
    1. Detectable major (or severe) congenital malformation identified before randomization.
    2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator’s opinion.
    3. Hypoglycemia at Baseline (blood glucose <45 mg/dL or 2.5 mmol/L) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
    4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and
    investigator’s opinion.
    5. Any other condition or therapy that, in the investigator’s opinion, may pose a risk to the subject or interfere with the subject’s potential compliance with this protocol or interfere with interpretation of results.
    6. Current or planned participation in a clinical study of another investigational study drug, device, or procedure (participation in observational studies is permitted on a case-by-case basis).
    7. The subject or subject’s parent(s) or legally authorized representative(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Time to final weaning off RTS, from Day 1 (ie, randomization) through 12 months CA:
    o RTS is defined as any one of the following: (1) any fraction of inspired oxygen (FiO2) >21%, (2) noninvasive respiratory support delivered via a nasal interface (e.g., continuous positive airway pressure [CPAP], bilevel positive airway pressure [BiPAP], high flow therapy, nasal intermittent positive pressure ventilation [NIPPV], nasal cannula), (3) invasive respiratory support (mechanical ventilation) via an endotracheal tube or tracheostomy.
    o During the birth hospitalization, RTS will be recorded daily by site personnel. After NICU discharge, daily RTS will be recorded weekly by parent(s)/caregiver(s), via an electronic device.
    o The day of final weaning off RTS is defined as the 7th consecutive day off RTS without any further RTS usage through 12 months CA.
    o Subjects who die before reaching 12 months CA will be considered not to have achieved final weaning off RTS, and will be handled in the primary analysis as a competing event. Subjects who prematurely terminate before 12 months CA will be considered to have achieved final weaning off RTS at the 7th day of no RTS with no return to RTS before premature termination; otherwise the subject will be considered not to have achieved final weaning off RTS, and censored at the date of withdrawal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Twelve months CA
    E.5.2Secondary end point(s)
    Chronic respiratory morbidity:
    o Incidence of BPD (yes/no) (as diagnosed by need for oxygen/respiratory support) at PMA 36 weeks or discharge home, and confirmed by oxygen challenge testing) or death through PMA 36 weeks
    o Total number of days on RTS from birth through 12 months CA
    o Duration of rehospitalizations due to respiratory diagnoses through 12 months CA
    o Number of emergency room visits associated with a respiratory diagnosis through 12 months CA
    o Number of days of respiratory medication use (eg, bronchodilators, steroids, leukotriene inhibitors, diuretics) through 12 months CA
    o Incidence of signs and symptoms of respiratory disease (yes/no), as assessed by caregiver-administered 28- day respiratory diaries during the 4 consecutive weeks prior to the 12 month CA visit
    o Incidence of CRM1 through 12 months CA as measured by respiratory health care utilization. A subject will be defined as having CRM1 if he or she has experienced/required at least 1 of the following 3 clinical/treatment events, as captured by the pulmonary morbidity assessment on at least two 3-month quarters over a 12-month time period. Assessments will be completed weekly by parent(s)/caregiver(s), via an electronic device, from NICU discharge to 12 months CA:
    1) Emergency room visit or hospitalization associated with a respiratory diagnosis
    2) Home RTS
    3) Daily use of respiratory medications (eg, bronchodilators, steroids, leukotriene inhibitors, diuretics) as reported by caregivers on the pulmonary morbidity assessment
    o Incidence of CRM2 through 12 months CA as measured by respiratory health care utilization and respiratory symptoms.
    A subject will be defined as having CRM2 if he or she has experienced/required at least 1 of the following 4 clinical/treatment events, as captured by the pulmonary morbidity assessment on at least two 3-month quarters over a 12-month time period. Assessments will be completed weekly by parent(s)/caregiver(s), via an electronic device, from NICU discharge to 12 months CA:
    1) Emergency room visit or hospitalization associated with a respiratory diagnosis
    2) Home RTS
    3) Daily use of respiratory medications (eg, bronchodilators, steroids, leukotriene inhibitors, diuretics) as reported by caregivers on the pulmonary morbidity assessment
    4) Symptoms of respiratory disease as defined by presence of cough without cold, or wheeze at least once per week
    o Severity of chronic respiratory morbidity (CRM3) through 12 months CA, as determined by the CLD of infancy severity score that will include components such as respiratory hospitalizations, RTS use, and use of respiratory medications.
    Neurologic outcomes
    o Incidence of IVH (yes/no) through PMA 40 weeks as assessed by centrally read cranial ultrasound.
    o Motor function at 12 months CA, as measured by AIMS
     Mean overall score on the PREMII functional status at PMA 36 weeks
     Incidence of ROP requiring treatment through PMA 40 weeks as per Early Treatment for Retinopathy of
    Prematurity (ETROP) definition
    o Mortality from birth through 12 months CA
    -Exposure-response pharmacokinetic/pharmacodynamic (PK/PD) relationships between IGF-1 exposure and respiratory and neurologic endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    Twelve months CA
    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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care
    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 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
    France
    Germany
    Hungary
    Ireland
    Israel
    Japan
    Korea, Democratic People's Republic of
    Netherlands
    Poland
    Portugal
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    Last subject last visit
    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 months5
    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 months11
    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: 477
    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: 477
    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
    The participants will be infants born prematurely. 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 238
    F.4.2.2In the whole clinical trial 477
    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)
    Subjects enrolled in this study (SHP607-202) will be invited to participate in a 4-year extension study to evaluate the long-term safety and clinical outcomes of SHP607 treatment at/before the 12 months CA/End of Study visit
    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 Decision2019-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-21
    P. End of Trial
    P.End of Trial StatusOngoing
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