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    Summary
    EudraCT Number:2018-001516-30
    Sponsor's Protocol Code Number:GDX-44-007
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-07-31
    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
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2018-001516-30
    A.3Full title of the trial
    Pharmacokinetics, safety and efficacy of a new gadolinium-based contrast agent, gadopiclenol, in pediatric patients from 2 to 17 years of ageundergoing contrast-enhanced MRI.
    Farmakokinetika, bezpečnosť' a účinnosť' novej gadolíniovej kontrastnej látky gadopiclenolu u pediatrických pacientov vo veku 2 až 17 rokov, ktorí podstúpili vyšetrenie MRI s podaním kontrastnej látky.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate product flow, breakdown and elimination from the body of a new contrast agent used in radiological examination and to evaluate its safety and efficacy in children from 2 to 17 years.
    A.4.1Sponsor's protocol code numberGDX-44-007
    A.5.4Other Identifiers
    Name:INDNumber:123673
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/076/2017
    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 pointRegulatory Affairs Pharmacist
    B.5.3 Address:
    B.5.3.1Street AddressBP57400
    B.5.3.2Town/ cityROISSY CDG CEDEX
    B.5.3.3Post code95943
    B.5.3.4CountryFrance
    B.5.4Telephone number+330145.91.76.26
    B.5.5Fax number+330145.91.46.69
    B.5.6E-mailMalychanh.le@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.3.2Product code gadopiclenol(form.G03277.066 &G03277.100)
    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
    D.3.9.4EV Substance CodeSUB120767
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.485
    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 Yes
    D.3.11.13.1Other medicinal product typeParamagnetic contrast agent
    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
    Pediatric subjects from 2 to 17 years old scheduled to undergo routine gadolinium contrast enhanced Magnetic Resonance Imaging of Central Nervous System
    E.1.1.1Medical condition in easily understood language
    Children and adolescents from 2 to 17 years old for which a brain or spine Magnetic Resonance Imaging with the injection of a contrast agent has been scheduled
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029817
    E.1.2Term Nuclear magnetic resonance imaging brain
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10072232
    E.1.2Term Nuclear magnetic resonance imaging spinal
    E.1.2System Organ Class 10022891 - Investigations
    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 from 2 to 17 years undergoing central
    nervous system (CNS) contrast-enhanced MRI (CNS cohort).
    E.2.2Secondary objectives of the trial
    1. To evaluate safety (clinical and biological) up to 3 months following single administration in both CNS and Body cohorts
    2. To evaluate urinary excretion of gadopiclenol quantitatively up to 8 hours and in subsequent urine samples collected up to 3 months following single administration in both CNS and Body cohorts (or
    exceptionally up to 4 months if collection is delayed due to the COVID-19 pandemic).
    3. To evaluate efficacy of gadopiclenol -enhanced MRI for CNS and body 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 2 to 17 years,
    2. Patient with known or suspected lesion(s) scheduled to undergo
    routine contrast-enhanced MRI of CNS or of other organs including at
    least one organ among head and neck, thorax, abdomen, pelvis and
    musculoskeletal system (including extremities),
    3. Patient whose parent(s) or legal guardian (where applicable) having
    read the information provided his/her/their consent to patient's
    participation in writing by dating and signing the informed consent prior
    to any trial related procedure being conducted,
    4. Patient with capacity of understanding who received age- and
    maturity-appropriate information and provided his/her assent to
    participate in the trial (as required by national regulations),
    5. 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 1 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 ranges [eGFR must be calculated based on bedside Schwartz equation],
    4.Patients referred for MR Angiography.
    5.Patient with history of bleeding disorder,
    6.Patient with known severe liver disease,
    7.Patient with known cardiac disease (e.g., heart rhythm anomalies, long QT syndrome),
    8.Patient with any clinically significant abnormal 12-lead ECG that in the Investigator's opinion would affect the safety evaluation or place the patient at risk,
    9.Patient with electrolyte or fluid imbalance that at Investigator's judgment presents undue risk assessed within 1 month prior to gadopiclenol administration,
    10.Patient undergoing a change in chemotherapy within 1 day prior to or 1 day after gadopiclenol administration,
    11.Patient who received or will receive any other contrast agent for CT and/or MRI within 1 week prior to or 1 week after gadopiclenol administration,
    12.Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker),
    13.Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents,
    14.Patient with history of hypersensitivity caused by any contrast media / agents (iodinated or gadolinium-based),
    15.Patient with known contraindication(s) to the use of any gadolinium based contrast agent (GBCA),
    16.Pregnant or breast-feeding female patient [female patient with childbearing potential (who experienced menarche) must have a negative urine pregnancy test within 24 hours prior to gadopiclenol administration and must be using medically approved contraception* if sexually active],
    17.Patient with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the patient's safety or her/his ability to participate to the whole trial,
    18.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,
    19.Having participated in a clinical trial and having received any investigational product within 7 days prior to gadopiclenol administration or planned during the trial,
    20.Patient previously included in this trial,
    21.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 will be assessed in the CNS cohort both by age group and overall based on following pharmacokinetic parameters determined from the population PK model:
    • Simulated concentrations at 10, 20 and 30 minutes post injection
    • Area Under the Curve,
    • Elimination half-life,
    • Total clearance,
    • Volume of distribution.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The start of administration is set as time point 0 (T0), and blood samples will be collected during four time windows as 1 to 20 min, 30 to 45 min, 2.0 to 3.0 hours and 7.0 to 8.0 hours post-injection
    E.5.2Secondary end point(s)
    Secondary criteria will be assessed in both CNS and Body cohorts.
    Clinical, biological and ECG safety data
    • Vital signs (temperature, systolic and diastolic blood pressure, pulse rate and pulse oximetry), prior to IMP injection, 30-90 min after and 1 day after IMP injection, Blood pressure and pulse rate will be measured after a rest for at least 5 minutes in supine position. Blood pressure will not be measured on the arm used for the injection. Blood oxygen saturation SpO2 (pulse oximetry) will be measured using a transcutaneous non-invasive light emitter.
    • 12-lead ECG recorded prior to IMP injection, 30-90 min after and 1 day after IMP injection.
    o Heart rate
    o Intervals: RR, PR, QRS, QT [corrected QT (QTc) will be calculated according to Fridericia and Bazett methods]
    o ST segments, T-wave morphology, U-wave
    o Global morphology
    ECG will be recorded after a rest for at least 5 minutes in supine position.
    A notable QTc change is defined as a QTc (Fridericia's or Bazett's) interval > 450 ms for males and females or an increase of >30 ms from baseline. All ECGs changes considered as abnormal and clinically significant according to Investigator's judgment will be reported as AEs.
    • Safety laboratory variables centrally analyzed (hematology and biochemistry) from blood samples collected prior to and 1 day after IMP injection:
    o Hematology: red blood cells (RBCs), white blood cells (WBCs) counts: neutrophils, eosinophils, basophils, lymphocytes and monocytes, platelet count, hemoglobin, hematocrit, mean red blood cells volume (MCV);
    o Biochemistry: sodium, potassium, chloride, glucose, blood urea nitrogen (BUN), creatinine, total protein, calcium, phosphorus, total bilirubin, conjugated bilirubin, aspartate amino transferase (AST),
    alanine amino transferase (ALT), alkaline phosphatase, lactate dehydrogenase (LDH), PT (prothrombin time) / INR (International Normalised Ratio);
    • Estimated glomerular filtration rate (eGFR) centrally calculated based on the bedside Schwartz equation prior to and 1 day after IMP injection, Bedside Schwartz equation [21-23] is used with creatinine methods with calibration traceable to isotope dilution mass spectroscopy (IDMS):
    eGFR (ml/min/1.73 m2 ) = (0.413 × Height in cm) / Standardized
    Serum creatinine (mg/dl)
    • Tolerance at the injection site (eruption, extravasation and inflammation) at T0, 30-90 min after and 1 day after IMP injection.
    • Adverse events (AE) occurred from the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation,
    • Clinical examination for active detection of Nephrogenic Systemic Fibrosis (NSF) at 3-month follow-up safety visit.
    Following symptoms will be recorded: burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle
    weakness.
    In case of suspicion of NSF a deep skin biopsy will be undertaken and results reported to the eCRF.
    • Gadopiclenol urine concentration will be measured in patients capable
    to control daytime urination:
    - in total urine quantitatively collected over 8 hours after gadopiclenol injection (or less if the confinement is not possible over this period due to the COVID-19 pandemic),
    - in spot urine samples 1 week and 3 months after gadopiclenol injection (or up to 1 month and 4 months after gadopiclenol injection if the urine sampling is delayed to visits V3-bis and V4-bis respectively due to the COVID-19 pandemic);
    • Gadopiclenol enhanced MRI (pre and pre+post comparison) efficacy evaluation in the CNS and Body cohorts by on site radiologist
    • PK profile in plasma will only be investigated in the cohort of patients undergoing CNS contrast-enhanced MRI (CNS cohort).
    • Safety, urinary excretion and efficacy of gadopiclenol will be evaluated in both CNS cohort and in the cohort of patients undergoing contrastenhanced MRI for diseases of other organs (Body cohort).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical, biological and ECG safety data
    • Vital signs prior to IMP inj., 30-90 min after and 1 day after IMP inj.
    • ECG recorded prior to IMP inj., 30-90 min after and 1 day after IMP inj.
    • Safety laboratory variables centrally analyzed prior to and 1 day after IMP injection.
    • eGFR prior to and 1 day after IMP inj.
    • Tolerance at the injection site at T0, 30-90 min after and 1 day after IMP inj.
    • AE monitored from the beginning of pts participation in the trial until the end of the participation
    • NSF at 3-month follow-up safety visit
    • IMP-urine concentration
    - in total urine quantitatively collected over 8 hours after IMP inj.
    - in spot urine samples 1 week and 3 months after IMP inj.
    • IMP-enhanced MRI efficacy evaluation in the CNS and body cohorts by on site radiologist
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Bulgaria
    Hungary
    Poland
    Slovakia
    Ukraine
    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 months9
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 80
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children and adolescents aged less than 15 years old can not give consent. Parents or
    legal representatives will consent for the participating child
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 80
    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 Decision2018-09-13
    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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