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    Summary
    EudraCT Number:2019-002615-25
    Sponsor's Protocol Code Number:GE-262-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-12-19
    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 number2019-002615-25
    A.3Full title of the trial
    An Open-label, Single-dose, Safety and Pharmacokinetic Study of Regadenoson in Paediatric Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to be conducted in many hospitals and in different countries
    with the medicinal substance Regadenoson to be used in a type of heart scan called ‘radionuclide myocardial perfusion imaging’ to see the blood flow in the heart muscle in patients aged between 1 month - 18 years.
    A.4.1Sponsor's protocol code numberGE-262-001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/015/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGE Healthcare 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 supportGE Healthcare Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGE Healthcare Ltd.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressPollards Wood, Nightingales Lane
    B.5.3.2Town/ cityChalfont St Giles
    B.5.3.3Post codeHP8 4SP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441494 544000
    B.5.6E-mailMichelle.Straszacker@ge.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 Rapiscan
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare AS
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRegadenoson
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNRegadenoson
    D.3.9.1CAS number 313348-27-5
    D.3.9.3Other descriptive nameREGADENOSON
    D.3.9.4EV Substance CodeSUB30494
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Patients who need to undergo a clinically indicated pharmacologic stress perfusion CMR test and who are considered fit for a pharmacological stress perfusion CMR by the investigator. The pharmacologic stress perfusion CMR may be performed in patients for further evaluation of cardiovascular conditions or diseases, such as, but not limited to, Kawasaki disease, congenital heart diseases, congenital coronary abnormalities, and post-cardiac surgery / transplantation, etc.
    E.1.1.1Medical condition in easily understood language
    Rapiscan is used in a type of heart scan called myocardial perfusion imaging. It belongs to a group of medicines called coronary vasodilators. It makes heart arteries expand and heart rate increase.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10028603
    E.1.2Term Myocardial perfusion scan
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10065141
    E.1.2Term Vascular diagnostic procedure
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate the safety and tolerability of a single, body-weight (weight category) adjusted intravenous (i.v.) bolus dose of regadenoson in paediatric patients aged 1 month to <18 years and who weigh at least 3 kg.

    2. To characterise the pharmacokinetics (PK) of a single, body-weight (weight category) adjusted i.v. dose of regadenoson and the effects on heart rate (HR) in 3 paediatric populations: adolescents aged 12 to <18 years, children aged 2 to <12 years, and infants aged 1 to <24 months, and who weigh at least 3 kg.
    E.2.2Secondary objectives of the trial
    1. To determine the relationship between regadenoson PK variables/exposure and changes in HR, including impact of patient factors.

    2. To determine the associated myocardial hyperaemic response after administration of regadenoson using dynamic first-pass perfusion magnetic resonance imaging (MRI) and quantitative myocardial perfusion reserve (MPR) analysis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may be included in the study if they meet all of the following criteria:
    1. Male or female adolescent aged from 12 to <18 years (Cohort A) or child aged from 2 to <12 years (Cohort B) or infant aged from 1 to <24 months (Cohort C).
    2. Patient weighs at least 3 kg.
    3. Patients who need to undergo a clinically indicated pharmacologic stress perfusion CMR test and who are considered fit for a pharmacological stress perfusion CMR by the investigator. The pharmacologic stress perfusion CMR may be performed in patients for further evaluation of cardiovascular conditions or diseases, such as, but not limited to, Kawasaki disease, congenital heart diseases, congenital coronary
    abnormalities, and post-cardiac surgery / transplantation, etc.
    4. Stable medication regimen for at least 7 days prior to dosing. Stable is defined as no addition, discontinuation, or change of any medications (or their doses), that could alter the rate-pressure product (HR x BP).
    5. Patients and those whose parents or legally authorised representatives are, in the Investigator’s view, likely to be compliant and complete the study will be eligible to participate.
    6. Post-menarchal female patients must have a negative urine pregnancy test at screening and at pre-dose on the dosing day.
    7. Post-menarchal female patients must be practicing abstinence, or be using an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 30 days before being enrolled in the study.
    8. Parents or legally authorised representatives have signed the Informed Consent Form for this study approved by the Ethics Committee or the Institutional Review Board (IRB) for the patient to participate in the study indicating that the patient (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study, and, for patients who are able, have signed age-appropriate paediatric assent.
    E.4Principal exclusion criteria
    Patients must be excluded from participating in this study if they meet any of the following criteria:
    1. Prior allergic reaction to Gd contrast agents and/or regadenoson or any component of its formulation, or to aminophylline or to its components (ethylenediamine and theophylline).
    2. Standard clinical contraindications to MRI as per institutional guidance, including patients with cochlear implants and implanted cardiac devices, or considered unfit for a pharmacologic stress perfusion CMR test by the investigator.
    3. All patients will be screened for eGFR within 24 hours before the exam and patients presenting with eGFR <30 mL/min/1.73 m2 (by the Schwartz formula) will be excluded.
    4. Pregnant or lactating females, or females of childbearing potential not using an acceptable form of birth control (negative urine pregnancy test also required).
    5. In the judgment of the Investigator, any clinically significant ongoing medical condition (e.g., myocardial infarction, or unstable angina within 5 days, pericardial inflammatory disease, severe cardiac outflow tract obstruction, acutely decompensated heart failure,
    uncontrolled epilepsy, high risk for seizures, etc.) or clinically significant laboratory abnormality that is considered to potentially jeopardise the patient’s safety.
    6. Patients with 2nd or 3rd degree AV block or sick sinus syndrome with or without an artificial pacemaker.
    7. Known or suspected bronchoconstrictive and bronchospastic lung disease either being unstable or requiring active treatment (e.g., wheezing noted on physical exam, frequent exacerbations or active treatment with a bronchodilator or corticosteroids).
    8. Out of acceptable range sitting or semi-recumbent resting BP or HR (beats per minute [bpm]) at screening as provided below:
    a) Acceptable range for BP (systolic / diastolic mmHg):
    - For Cohorts A and B: 85−130 / 45−90
    - For Cohort C: 80-120 / 40-80
    b) Acceptable range for HR:
    - For Cohort A: 55 to 100 bpm
    - For Cohort B: 60 to 120 bpm
    - For Cohort C: 70 to 160 bpm
    9. Use of any experimental or investigational drug or device within 30 days prior to dosing with study drug.
    10. Consumption of methylxanthine-containing products such as caffeinated coffee, tea, caffeinated soft drinks, cocoa or chocolate in the 48 hours prior to dosing.
    11. Aminophylline or theophylline use within 24 hours, dipyridamole use within 48 hours prior to dosing.
    12. History of alcohol abuse or drug addiction, as determined by the Investigator.
    13. Positive urine drug screen at the screening visit, including amphetamines, barbiturates,
    cannabinoids, cocaine, ethanol and opiates. This will be performed for all patients in Cohort A and those patients at age-appropriate risk in Cohorts B and C, as determined by the investigator.
    Note: If the patient is currently receiving prescribed medications containing any of these ingredients, re-screening can only be considered if found acceptable based on the best medical judgement of the investigator and after discussion with the medical monitor. Otherwise, patients with a positive urine drug test will be considered a screen failure.
    14. Currently smokes more than 5 cigarettes or equivalent per day, and if eligible for the study, would not be able to abstain from smoking from midnight prior to dosing until the end of the study period.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Safety Endpoints:
    Occurrence of AEs, including AEs of special interest (AESIs), changes in physical examination, vital signs (BP, HR, oxygen saturation, body temperature), ECG evaluation, clinical laboratory tests (serum chemistry), and post-regadenoson-dosing concomitant medications.

    Primary Pharmacokinetic Endpoints:
    For Cohort A, plasma samples for measurement of regadenoson concentrations will be collected at 1, 3, 5, 10, and 20 minutes, and at 1 and 2 hours post-regadenoson dose. Concentration-time profiles will be evaluated using compartmental methods and a population approach with mixed-effect modelling. The effect of patient factors (such as, but not limited to age, gender, body weight, height, body mass index (BMI), body surface area (BSA), renal function [SCr, eGFR]) on the PK variables will be assessed. For Cohorts B and C, population PK modelling similar to that used in Cohort A will be applied. The frequency, time points, and/or sampling windows of blood draws for PK will be determined after analysis of the data from Cohort A (for Cohort B) and after analysis of data from Cohorts A and B (for Cohort C), and will be adjusted based on the volume of blood allowed to be drawn from patients in each age group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation will begin at the time of patient consent for
    the trial, and continue through completion of the study, or early withdrawal/termination. Collection of AEs will continue through study completion or withdrawal/termination after the final PK blood draw (at 2 hours postregadenoson dose) with an additional recommended observation as considered appropriate based on the patient’s condition and/or local standard of care practice, and at the follow-up visit at 48 hours (±12 hours).
    E.5.2Secondary end point(s)
    Secondary Pharmacodynamic Endpoints:
    The relationship between regadenoson PK variables/exposure and changes in HR will be assessed, including impact of patient factors (e.g., age, gender, body weight, height, BMI, BSA, renal function [SCr, eGFR]).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The associated myocardial hyperaemic response after administration of regadenoson using dynamic first-pass perfusion CMR and the MPR starting at 2 minutes after regadenoson injection will be assessed. The quantitative CMR endpoint (MPR) will be assessed in a central read at the end of the study by an independent reader blinded to the clinical outcome/management decisions of the patient.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    France
    Germany
    Greece
    Italy
    Netherlands
    Spain
    Switzerland
    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 end of the study is defined as the date 6 months after the last scheduled clinic visit shown in the Study Schedule of Events (deemed as the 48-hour clinic visit) for the last patient in the trial.
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 54
    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: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 18
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    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 Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 54
    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)
    The study medication will not be provided by the sponsor upon completion of the subject's participation in the 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 Decision2020-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-27
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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