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    Summary
    EudraCT Number:2018-001393-16
    Sponsor's Protocol Code Number:OHB-607-202
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2019-01-28
    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 ConcernedSweden - MPA
    A.2EudraCT number2018-001393-16
    A.3Full title of the trial
    A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 in Preventing Chronic Lung Disease in Extremely Premature Infants Compared to Standard Neonatal Care
    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 numberOHB-607-202
    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 SponsorOHB Neonatology Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportOHB Neonatology Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOHB Neonatology Ltd
    B.5.2Functional name of contact pointCustomer Services
    B.5.3 Address:
    B.5.3.1Street Address1 Ashley Road, 3rd Floor
    B.5.3.2Town/ cityAltrincham, Cheshire
    B.5.3.3Post codeWA14 2DT
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailinfo@oakhillbio.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 nameOHB-607 (mecasermin rinfabate, rhIGF-1/rhIGFBP-3)
    D.3.2Product code OHB-607
    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 codeOHB-607, 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 OHB-607 on reducing the burden of CLD, as indicated by a reduction in the incidence of severe BPD at 36 weeks (±3 days) PMA, or death, whichever comes first as compared to the SNC group.
    E.2.2Secondary objectives of the trial
    The key secondary objective of this study is to assess the effect of OHB-607 on occurrence of severe (Grade 3 and 4) IVH at 36 weeks PMA, as assessed by cranial ultrasound as compared to the SNC group.

    Other Secondary Objectives: To assess the effect of OHB-607, as compared to the SNC group, on:
    • Incidence and severity of BPD.
    • Incidence and severity of IVH
    • Neurodevelopment outcomes.
    • Incidence and severity of ROP.
    • Mortality from birth through to 24 months CA.
    • Exposure-response PK/PD relationships
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consents and/or assents must be signed and dated by the subject's parent(s) prior to any study-related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations).
    2. Written informed consents and/or assents must be signed and dated by the subject's birth mother 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 (in accordance with local regulations).
    3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, 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 treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
    7. The subject or subject’s parent(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.
    8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.

    Major (or severe) congenital malformations include structurally significant congenital heart disease, and structural abnormalities of the upper airway, lungs or chest wall. Congenital malformations that are suspected of being associated with chromosomal abnormalities, genetic syndromes, and neoplasia should be excluded, as well as abnormalities that may affect life expectancy, cardiopulmonary development, neurologic development, or
    interpretation of study results.

    Isolated minor dysmorphic anomalies that are unlikely to be exclusionary could include post-axial polydactyly, ankyloglossia, accessory nipples, preauricular pits, single or horizontal palmar crease, clinodactyly, and single umbilical artery. However, the presence of multiple minor anomalies in the same infant may be exclusionary.

    Uncomplicated infantile hemangiomas are unlikely to be exclusionary. However, subjects with infantile hemangiomas that may be associated with potential for disfigurement, life-threatening complications, functional impairment, ulceration, or underlying abnormalities should be excluded.

    Inclusion/exclusion will ultimately be determined by the investigator, based on assessment of the clinical presentation of each candidate subject and the likelihood that physical finding(s) are associated with a condition that impacts health and development.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of severe BPD (as defined by the modified NICHD severity grading) for all subjects at 36 weeks PMA. The definitions for BPD are based upon the modified NICHD guidelines for preterm infants born at <32 weeks GA:
    • No BPD: oxygen for <28 days or none.
    • Mild BPD: a need for oxygen for ≥28 days but on room air at 36 weeks PMA.
    • Moderate BPD: oxygen for ≥28 days plus treatment with <30% oxygen at 36 weeks PMA.
    • Severe BPD: oxygen for ≥28 days plus oxygen >30% or positive pressure, or high flow nasal cannula ≥2 L/minute at 36 weeks PMA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 36 weeks PMA.
    E.5.2Secondary end point(s)
    Key Secondary Endpoint:
    Incidence of severe (Grade 3 and 4) IVH at 36 weeks PMA (or discharge from/transfer from the NICU, whichever comes first) as assessed by centrally read cranial ultrasound and classified according to the Volpe criteria:
    • Grade 1: blood in the germinal matrix with or without IVH <10% of ventricular space.
    • Grade 2: IVH occupying 10 to 50% of ventricular space on parasagittal view.
    • Grade 3: IVH occupying >50% of ventricle with or without ventricular echo-densities.
    • Grade 4: evidence of PHI.
    • Incidence of severity of all grades of BPD according to the modified NICHD guidelines for preterm infants born at <32 weeks GA analyzed separately: none, mild, moderate and severe BPD.
    • Incidence of all grades of IVH as assessed by centrally read cranial ultrasound and classified according to the Volpe criteria.
    • Neurodevelopmental impairment as determined by BSID at 12 and 24 months CA.
    • Physical and cognitive development as measured by ASQ®-3 administered at 6, 12, 18 and 24 months CA.
    • Incidence and severity of ROP through 36 weeks PMA according to ETROP definition and assessed by centralized review.
    • Mortality rates from >12 hours after birth to initial hospital discharge and from initial discharge through 24 months CA.
    • Relationships between IGF-1 exposure and respiratory, neurologic, BPD, IVH, NEC and ROP endpoints.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 36 weeks PMA and at 12 and 24 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 trial2
    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 EEA30
    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
    Japan
    United States
    Finland
    France
    Sweden
    Netherlands
    Spain
    Germany
    Italy
    Ireland
    Portugal
    United Kingdom
    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
    The date the final subject, across all sites, completes their final protocol-defined assessment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days9
    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: 338
    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: 338
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 99
    F.4.2.2In the whole clinical trial 338
    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)
    After trial completion, subjects will return to standard of care for any ongoing health issues.
    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 Decision2019-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-02
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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