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    The EU Clinical Trials Register currently displays   44234   clinical trials with a EudraCT protocol, of which   7336   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:2010-023003-96
    Sponsor's Protocol Code Number:BAY86-4875/91741
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-24
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-023003-96
    A.3Full title of the trial
    Open-label, multicenter, pharmacokinetic, and safety study in children (term newborn infants to 23 months of age) undergoing a contrast-enhanced MRI with an intravenous injection of 0.1 mmol/kg BW gadobutrol 1.0 M (Gadovist 1.0)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gadobutrol pharmacokinetic and safety study in pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive)
    A.4.1Sponsor's protocol code numberBAY86-4875/91741
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/176/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team / Ref: "EU CTR" Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 Gadovist® 1.0 mmol/ml, solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderBayer HealthCare AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGadovist® 1.0 mmol/ml, solution for injection
    D.3.2Product code BAY 86-4875
    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 INNgadobutrol
    D.3.9.1CAS number 138071-82-6
    D.3.9.2Current sponsor codeBAY 86-4875
    D.3.9.3Other descriptive nameGADOBUTROL
    D.3.9.4EV Substance CodeSUB07861MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/ml millimole(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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
    Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive) scheduled to undergo routine gadolinium-enhanced MRI of any body region
    E.1.1.1Medical condition in easily understood language
    Pediatric subjects aged <2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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
    To evaluate the pharmacokinetics of gadobutrol in plasma at the standard dose of 0.1 mmol/kg body weight in pediatric subjects aged <2 years.
    E.2.2Secondary objectives of the trial
    To evaluate safety and tolerability of gadobutrol at the standard dose of 0.1 mmol/kg BW in pediatric subjects aged <2 years.

    To evaluate qualitatively gadobutrol-enhanced images at the standard dose of 0.1 mmol/kg BW in pediatric subjects aged <2 years following MRI for any indication.

    To estimate the glomerular filtration rate prior to injection of gadobutrol, based on the Schwartz formula.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive) scheduled to undergo routine gadolinium-enhanced MRI of any body region
    E.4Principal exclusion criteria
    - Subjects undergoing a change in chemotherapy within 48 hours prior to and up to 24 hours after gadobutrol injection
    - Any planned intervention during the study and up to 24 hours after gadobutrol injection (excluding lumbar puncture)
    - Subjects who received or will receive any investigational product within 48 hours before gadobutrol injection or during study participation
    - Subjects who received or will receive any other contrast agent within 48 hours prior to gadobutrol injection or up to 24 hours after gadobutrol injection
    - Subjects with contraindication for MRI such as iron metal implants (e.g. aneurysm clips)
    - History of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
    - Subject with renal insufficiency of any intensity, i.e. eGFR <80% of age adjusted normal value calculated based on the Schwartz formula
    E.5 End points
    E.5.1Primary end point(s)
    1)To evaluate the typical and individual area under the curve (AUC) of gadobutrol in plasma
    2)To evaluate the simulation of plasma concentration 20 minutes post-injection of gadobutrol
    3) Total body clearance of Gadobutrol from plasma
    4) Apparent volume of distribution of Gadobutrol at steady state
    5) Terminal elimination half-life of Gadobutrol
    6) Mean residence time of Gadobutrol
    E.5.1.1Timepoint(s) of evaluation of this end point
    Multiple time points within 8 hours post-injection
    E.5.2Secondary end point(s)
    1) Adverse event collection
    2) Quality of Gadobutrol-enhanced magnetic resonance images as assessed by investigator; Key quality aspects assessed by investigators will include Contrast Quality, Degree of contrast-enhancement in lesion or vessel, Border delineation of lesion or vessel, Visualization of lesion-internal morphology.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) From baseline to approximately 7 days after injection of gadobutrol
    2) Pre-injection, and immediately post-injection (as defined by investigator based on clinical need, estimated between 1 and 15 minutes post injection)
    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) Yes
    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) 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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    United States
    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
    For each participating EU country, the end of the study according to the EU Clinical Trial Directive will be reached when the last follow-up telephone call of the last subject for all centers in the respective country has occured.
    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 months0
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days7
    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.1.1.4Infants and toddlers (28 days-23 months) Yes
    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
    pediatric subjects aged <2 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    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)
    Not applicable for this 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 Decision2012-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-17
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