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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-003825-31
    Sponsor's Protocol Code Number:GDX-44-015
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2022-02-10
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-003825-31
    A.3Full title of the trial
    Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age Undergoing Contrast-enhanced MRI Phase II Clinical Trial
    P/0145/2019
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the safety, efficacy of gadopiclenol and how this drug is absorbed, distributed, metabolized, and eliminated from the body in children less than 2 years.
    A.4.1Sponsor's protocol code numberGDX-44-015
    A.5.4Other Identifiers
    Name:IND No.: Number:123673
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/055/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGuerbet
    B.1.3.4CountryFrance
    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 supportGuerbet
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuerbet
    B.5.2Functional name of contact pointGlobal RegulatoryAffairs Pharmacist
    B.5.3 Address:
    B.5.3.1Street AddressB.P. 57400
    B.5.3.2Town/ cityRoissy CdG Cedex
    B.5.3.3Post code95943
    B.5.3.4CountryFrance
    B.5.4Telephone number+3314591 7201
    B.5.6E-maillucie.begert@guerbet.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 namegadopiclenol
    D.3.2Product code P03277
    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 INNGadopiclenol
    D.3.9.1CAS number 933983-75-6
    D.3.9.2Current sponsor codeP03277, G03277
    D.3.9.4EV Substance CodeSUB194566
    D.3.10 Strength
    D.3.10.1Concentration unit mol/l mole(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    Known or highly suspected abnormalities/ lesion(s) as detected by previous imaging examinations (including the fetal imaging) that need to be investigated by contrast-enhanced MRI of any body region including CNS.
    E.1.1.1Medical condition in easily understood language
    Defect(s) or lesion(s) previously detected by imaging in any body region that need to be investigated by Magnetic Resonance Imaging
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10029815
    E.1.2Term Nuclear magnetic resonance imaging
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10058644
    E.1.2Term Nuclear magnetic resonance imaging whole body
    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
    To evaluate the pharmacokinetic profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS).
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety of gadopiclenol (clinical and biological) up to 3 months following single administration.
    2. To evaluate the efficacy of gadopiclenol-enhanced MRI by body region (CNS, vessels and pool of others) as assessed by on-site Investigator.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female or male pediatric patient aged from birth to 23 months of age inclusive (term neonates for all age groups or preterm infants after the neonatal period for groups 1 or 2). The neonatal period for preterm newborns is defined as the day of birth through the expected date of delivery plus 27 days. Term is defined as ≥37 completed weeks of amenorrhea.
    2. Patient with known or highly suspected abnormalities/ lesion(s) as detected by previous imaging examinations (including the fetal imaging, scheduled to undergo contrast-enhanced MRI of any body region including CNS.
    3. Patient whose parent(s) or legal guardian (where applicable) having read the information has/have provided his/her/their consent to patient’s participation in writing by dating and signing the informed consent form prior to any trial related procedure being conducted.
    4. Patient affiliated to national health insurance according to local regulatory requirements.
    E.4Principal exclusion criteria
    1. Patient planned for treatment or procedure (e.g. surgery) that would prevent from obtaining the required blood samples or performing other trial procedures between the screening visit and up to one day after gadopiclenol administration.
    2. Patient undergoing treatment or procedure (e.g., diuretics, clinically significant blood loss or blood transfusion) preceding or subsequent to gadopiclenol administration that would alter gadopiclenol pharmacokinetic parameters.
    3. Patient with acute or chronic renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) out of age-adjusted normal value calculated based on bedside Schwartz equation.
    4. Patient presenting with known class III/IV congestive heart failure according to the Modified Ross Heart Failure Classification in Children.
    5. Patient with history of bleeding disorder.
    6. Patient with known severe liver disease.
    7. Patient with known cardiac arrhythmia (e.g., heart rhythm anomalies, long QT syndrome).
    8. Patient with electrolyte or fluid imbalance that at Investigator’s judgment presents undue risk assessed within one month prior to gadopiclenol administration.
    9. Patient undergoing a change in chemotherapy (product or dosage) within one day prior to or one day after gadopiclenol administration.
    10. Patient who received or will receive any other contrast agent for CT and/or MRI within one week prior to or one week after gadopiclenol administration.
    11. Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker).
    12. Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
    13. Patient with history of hypersensitivity caused by any contrast media / agents (iodinated or gadolinium-based).
    14. Patient with known contraindication(s) to the use of any gadolinium-based contrast agent (GBCA).
    15. Patient with anticipated, current or past condition (medical with particular attention to prematurity, psychological, social or geographical) that would compromise the patient’s safety or her/his ability to participate to the whole trial.
    16. Patient unlikely to comply with the protocol, e.g., uncooperative attitude of parent(s) or legal guardian (where applicable), inability to return for follow-up visits and unlikelihood of completing the trial.
    17. Patient having participated in a clinical trial and having received any investigational product within one week prior to or planned within one week after gadopiclenol administration.
    18. Patient previously included in this trial.
    19. Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct.
    E.5 End points
    E.5.1Primary end point(s)
    Gadopiclenol pharmacokinetics in plasma for pediatric patients aged up to 23 months (inclusive) will be assessed based on the following pharmacokinetic parameters determined from the population PK model:
    o Simulated concentrations at 10, 20 and 30 minutes post injection,
    o Area Under the Curve,
    o Elimination half-life,
    o Total clearance,
    o Volume of distribution.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 blood samples will be collected per patient (one sample will be obtained during the 10-60 minutes time window, the second sample will be obtained during the 2.0-4.0 hours’ time window and the third sample will be obtained during the 6.0-8.0 hours’ time window post-injection)
    E.5.2Secondary end point(s)
    The following clinical and biological safety parameters/examinations will be measured/performed:
    o Physical examination at visits 1, 2 (if applicable), 3, 4 and 5 including examination of general appearance, skin (including extremities), neck (including thyroid), eyes, abdomen, back, lymph nodes, peripheral vascular and neurological examination and other (any other observed abnormalities).
    o Vital signs (temperature, blood pressure, pulse rate and peripheral oxygen saturation (SpO2)) at 3 time points: prior to IMP injection, 10-60 min and 1 day after IMP injection.
    o Safety laboratory variables centrally analyzed (biochemistry and hematology) from blood samples collected prior to and 1 day after IMP injection,
    o Estimated glomerular filtration rate (eGFR) centrally calculated based on the bedside Schwartz equation prior to and 1 day after IMP injection,
    o Tolerance at the injection site at 3 time points: during injection, 10-60 min and 1 day after IMP injection,
    o Adverse events (AE) occurring from the beginning of patient’s participation in the trial (Informed Consent Form signature) until the end of the participation.
    o Clinical examination for active detection of Nephrogenic Systemic Fibrosis (NSF) at 3-month follow-up safety visit. In case of suspicion of NSF a deep skin biopsy will be performed.
    Efficacy will be assessed by on-site radiologist for both pre-contrast (Pre) and pre+post contrast (Paired) images, assessments will be performed for the primary anatomical area to be evaluated based on following parameters:
    o Technical adequacy for diagnosis using a 4-point scale: non diagnostic (reasons to be provided), poor, fair and good.
    o Assessment of overall contrast quality using a 5-point scale: 1= None (for example, in case of a non-enhancing lesion), 2= Poor, 3= Moderate, 4= Good, 5= Excellent.
    o Number and location of lesions/abnormal vessels, the largest diameter (lesions only) of three most representative lesions/abnormal vessels will be recorded.
    o Quantitative assessment (not applicable for vessels): percentage of enhancement (E%) and Lesion to Background Ratio (LBR) and Contrast to Noise Ratio (CNR) for CNS only for up to 3 most representative lesions (largest enhancing lesions).
    o Lesion/vessel visualization (border delineation, internal morphology and degree of contrast enhancement) for up to 3 most representative lesions or vessel abnormalities using a 4-point scale for each parameter.
    o Change in diagnosis from Pre to Paired MRI : yes/no/not assessable
    o Change in diagnostic confidence from Pre to Paired MRI, defined as the degree of confidence that the information on the images represents the true and complete clinical picture of a patient: yes/no/not assessable
    o Change in treatment plan from Pre to Paired MRI: yes/no/not assessable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Physical examination at visits 1, 2, 3, 4 and 5
    Vital signs: prior to IMP injection, 10-60 min and 1 day after IMP injection.
    Biochemistry, hematology and eGFR prior to and 1 day after IMP injection
    Tolerance at the injection site: during injection, 10-60 min and 1 day after IMP injection
    AEs during the entire study participation
    Clinical examination for active detection of Nephrogenic Systemic Fibrosis (NSF) at 3-month follow-up safety visit.
    Efficacy will be assessed for both pre-contrast (Pre) and pre+post contrast (Paired) images
    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 Yes
    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 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 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 concerned6
    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
    United States
    Poland
    Bulgaria
    Hungary
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 50
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 5
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 45
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 50
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-14
    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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