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    Summary
    EudraCT Number:2016-001974-14
    Sponsor's Protocol Code Number:CCD-050000-01
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2023-08-11
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2016-001974-14
    A.3Full title of the trial
    An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates with Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (poractant alfa, Curosurf®) Administration: a Less Invasive Method (LISA) During Non-Invasive Ventilation (NIV) and the Conventional Administration During Brief Invasive Ventilation.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in preterm neonates with Respiratory Distress Syndrome (RDS) to compare CUROSURF® administration through LISA and conventional administration (LISPAP).
    A.3.2Name or abbreviated title of the trial where available
    LISPAP (Less Invasive Surfactant administration combined with nCPAP)
    A.4.1Sponsor's protocol code numberCCD-050000-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02772081
    A.5.4Other Identifiers
    Name:127511Number:IND
    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 SponsorChiesi Farmaceutici S.p.A.
    B.1.3.4CountryItaly
    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 supportChiesi Farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiesi Farmaceutici S.p.A.
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressVia Palermo, 26/A
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43122
    B.5.3.4CountryItaly
    B.5.6E-mailclinicaltrials_info@chiesi.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 Yes
    D.2.1.1.1Trade name Curosurf
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi USA, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Endotracheopulmonary instillation, suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPEndotracheopulmonary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPORACTANT ALFA
    D.3.9.1CAS number 129069-19-8
    D.3.9.2Current sponsor codeCHF1534
    D.3.9.3Other descriptive namePORACTANT ALFA
    D.3.9.4EV Substance CodeSUB22150
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Yes
    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
    Treatment of Respiratory Distress Syndrome (RDS) in spontaneously breathing preterm neonates.
    E.1.1.1Medical condition in easily understood language
    Treatment of Respiratory Distress Syndrome (RDS) in spontaneously breathing preterm neonates.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to evaluate the safety profile of the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA) using a thin catheter (CHF 6440) during non-invasive ventilation (NIV), compared to conventional surfactant administration during invasive ventilation and rapid extubation, in spontaneously breathing preterm neonates with clinical signs of respiratory distress syndrome (RDS). The short-term and mid-term safety will be assessed: adverse events and adverse drug reactions occurring during overall procedure for surfactant administration, neonatal pain assessment pre- and during surfactant administration, duration of surfactant administration, incidence of bronchopulmonary dysplasia (BPD) at 36 weeks post menstrual age
    (PMA) , major neonatal morbidities and vital signs.
    E.2.2Secondary objectives of the trial
    Short-term and mid-term efficacy profile will also be assessed mainly in terms of: reduced oxygen requirement and ventilatory support, need for invasive mechanical ventilation in the first 72 hours of life and throughout the study period, duration of invasive and non-invasive ventilation and need for additional surfactant doses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all the following inclusion criteria to be eligible for enrollment into the study:
    1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth;
    2. Preterm neonates of either sex aged ≥30 minutes and <24 hours, spontaneously breathing and stabilized on NIV;
    3. Gestational age of 25+0 weeks up to 28+6 completed weeks; enrollment will be restricted to subjects aged 27+0 weeks up to 28+6 GA weeks until safety evaluation of first 15 subjects is completed;
    4. Clinical course consistent with RDS;
    5. FiO2 ≥0.30 to maintain preductal SpO2 in the target range of 88–95%.
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a subject from the study enrollment:
    1. Need for immediate endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive;
    2. Use of nasal high frequency oscillatory ventilation (nHFOV) prior to study entry;
    3. Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide);
    4. Known genetic or chromosomal disorders, major congenital anomalies (congenital heart diseases, myelomeningocele, etc);
    5. Mothers with prolonged premature rupture of the membranes (>21 days duration) which could cause complications (in particular severe pulmonary hypoplasia due to oligohydramnios);
    6. Presence of air leaks if identified and known prior to study entry;
    7. Evidence of severe birth asphyxia (e.g. continued need for resuscitation at 10 minutes after birth, altered neurological state or neonatal encephalopathy);
    8. Neonatal seizures prior to study entry;
    9. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk;
    10. Participation in another clinical trial of any medicinal product, placebo, experimental medical device or biological substance conducted under the provisions of a protocol on the same therapeutic target; the participation in studies involving diagnostic devices or studies with treatments for different conditions than lung and respiratory function impairments may be permitted following an agreement with the sponsor. Non-interventional observational studies are allowed.
    E.5 End points
    E.5.1Primary end point(s)
    1. Main Safety Outcome: Number and percentage of neonates with adverse events started during the procedure for surfactant administration and judged related to the procedure;
    2. Main Safety Outcome: Incidence of AEs (including neonatal complications of prematurity), incidence of adverse drugs reactions, incidence of serious adverse events, incidence of AEs leading to death;
    3. Main Safety Outcome: Number of first failed attempts to insert the catheter/endotracheal tube and percentage of neonates with first failed attempt;
    4. Main Safety Outcome: Incidence of death at 36 weeks PMA;
    5. Main Safety Outcome: Incidence of bronchopulmonary dysplasia at 36 weeks PMA;
    6. Main Safety Outcome: Health status at discharge or 40 weeks PMA (whichever comes first): feeding status, hearing status, growth parameters, need for respiratory support or respiratory medication.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. [Time Frame: From the application of the laryngoscope up to the removal of the CHF 6440 catheter or the endotracheal tube]
    2. [Time Frame: From the application of the laryngoscope up to the end of the main phase of the study (discharge or 40 weeks Post-Menstrual Age [PMA], whichever comes first)]
    3. [Time Frame: At first surfactant administration]
    4. [Time Frame: 36 weeks PMA]
    5. [Time Frame: 36 weeks PMA]
    6.[Time Frame: Discharge or 40 weeks PMA (whichever comes first)].
    E.5.2Secondary end point(s)
    1. Main Efficacy Outcome: Percentage of neonates needing invasive mechanical ventilation;
    2. Main Efficacy Outcome: Median duration of invasive mechanical ventilation;
    3. Main Efficacy Outcome: Preductal Oxygen Saturation (SpO2), Fraction of Inspired Oxygen (FiO2) and SpO2/FiO2 ratio;
    4. Main Efficacy Outcome: Percentage of neonates requiring at least one additional surfactant dose.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Main Efficacy Outcome: Percentage of neonates needing invasive mechanical ventilation
    [Time Frame: First 72 hours of life, Up to 28 days Post-Natal Age
    (PNA), Up to 36 weeks PMA]
    2. Main Efficacy Outcome: Median duration of invasive mechanical ventilation
    [Time Frame: First 72 hours of life, Up to 28 days PNA, Up to 36 weeks PMA]
    3. Main Efficacy Outcome: Preductal Oxygen Saturation (SpO2), Fraction of Inspired Oxygen (FiO2) and SpO2/FiO2 ratio
    [Time Frame: Time 0 (study treatment administration), 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72 and 120 hours post treatment]
    4. Main Efficacy Outcome: Percentage of neonates requiring at least one additional surfactant dose
    [Time Frame: First 72 hours of life]
    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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Conventional administration of Curosurf during brief invasive ventilation.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    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: 150
    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: 150
    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
    Spontaneously breathing preterm neonates with clinical signs of
    respiratory distress syndrome (RDS).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 150
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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