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    Summary
    EudraCT Number:2008-005288-33
    Sponsor's Protocol Code Number:EMI111784
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-01-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-005288-33
    A.3Full title of the trial
    Methodology Study to develop Sinerem enhanced 3T MR Imaging of Atherosclerotic Plaques within the Carotid Arteries, and to compare Sinerem MRI to contrast enhanced ultrasound
    A.4.1Sponsor's protocol code numberEMI111784
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development, LtdD
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameSinerem
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNFerumoxtran-10 (USAN)
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFerumoxtran-10 (USAN)
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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 SonoVue
    D.2.1.1.2Name of the Marketing Authorisation holderBracco International B.V.
    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 nameSonoVue
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namesulphur hexafluoride microbubbles
    D.3.10 Strength
    D.3.10.1Concentration unit µl/ml microlitre(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Atherosclerotic plaque within the carotid artery.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10051615
    E.1.2Term Atherosclerotic cardiovascular disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To develop Sinerem enhanced MRI data acquisition and analysis methods at 3T in order to characterize macrophage uptake in atherosclerotic plaques within the carotid
    artery.
    E.2.2Secondary objectives of the trial
    • To determine the optimal Sinerem dose for use of MRI scanning of carotid atherosclerosis at 3T.
    • To evaluate the test-retest reproducibility of a specific set of structural and T2*
    related metrics in Part C (which we will develop in Parts A and B) over two scanning
    sessions in subjects with atherosclerosis.
    • To contribute safety data to the Guerbet Sinerem Global Safety Database.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female between 18 and 80 years of age inclusive. Women must be of nonchildbearing potential, defined as:
    • Pre-menopausal females with a documented tubal ligation or hysterectomy;
    • Postmenopausal defined as 12 months of spontaneous amenorrhea.
    2. Atherosclerotic plaque within the carotid artery as assessed by carotid ultrasound
    either documented prior to screening or detected at the screening visit.
    3. Capable of giving written informed consent, which includes compliance with the
    requirements and restrictions listed in the consent form.
    4. Participants must read and write (in English) at a level sufficient to complete study
    related assessments.
    5. Able to understand and comply with protocol requirements, instructions and
    protocol-stated restrictions and is willing to take part in the imaging sessions.
    6. Registered with a UK general practitioner
    E.4Principal exclusion criteria
    Parts A, B, C:
    1. Pregnant females as determined by positive urine hCG test at screening and prior to each MRI scanning session.
    2. Contraindication to MRI scanning including but not limited to:
    3. Intracranial aneurysm clips (except Sugita) with an appropriate operative conformation,
    • History of intra- orbital metal fragments that have not been removed by an MD,
    • Pacemakers and non-MR compatible heart valves,
    • Inner ear implants,
    • History of claustrophobia.
    4. History of any of the following medical conditions:
    • Myocardial Infarction or Cerebrovascular Accident within the past 2 weeks
    • Severe heart failure (NYHA class III-IV or ejection fraction < 30%)
    • Malignancy within the past 5 years (other than non-melanoma skin cancer)
    • Poorly controlled hypothyroidism or thyrotoxicosis.
    • Chronic viral hepatitis or other chronic hepatic disorders; Severe infection
    within 4 weeks prior to screening.
    5. Current life-threatening condition that may prevent a subject from completing the
    study.
    6. Any other subject the investigator and GSK medical monitor deems unsuitable for
    the study
    7. Unwillingness or inability to follow the procedures outlined in the protocol.
    8. Planned carotid surgery or endovascular intervention within the study period.
    9. The subject is a GSK employee, contractor currently working for GSK, or an
    immediate family member of a GSK employee.
    Part D:
    1. Exclusion criteria 1 – 8 as in Part A, B, and C
    2. Pregnant females as determined by positive urine hCG test at screening and prior to each CEUS and MRI scanning session.
    3. Subjects who have been taking atorvastatin at a dose of > 20mg (or equivalent) for four full weeks prior to screening.
    4. Exclusion criteria relating to Sinerem infusion, including but not limited to:
    • A history of clinically significant atopy (e.g. anaphylaxis, skin rash to medication or topical therapies, hypersensitivity to iodinated contrasts, allergies to food (e.g. shellfish), bronchial asthma, etc.),
    • Allergy to dextran or iron salts
    • Haemachromatosis or other condition putting subject at risk of iron overload
    • Chronic severe back pain
    5. Exclusion criteria relating to SonoVue, including but not limited to:
    • A history of known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue.
    • Evolving or ongoing myocardial infarction, typical angina at rest within last 7
    days, significant worsening of cardiac symptoms within last 7 days, recent
    coronary artery intervention or other factors suggesting clinical instability (for
    example, laboratory or clinical findings), acute cardiac failure, Class III/IV
    cardiac failure, or severe rhythm disorders on ECG (as determined by the
    Principal Investigator).
    • A history of right-to-left shunts, severe pulmonary hypertension (pulmonary
    artery pressure >90 mmHg), uncontrolled systemic hypertension, and in subjects
    with adult respiratory distress syndrome.
    • A history of clinically significant pulmonary disease, including severe chronic
    obstructive pulmonary disease.
    • A history of acute endocarditis, prostetic valves, acute systemic inflammation
    and/or sepsis, hyperactive coagulation states and/or recent thromboembolism,
    and end-stage renal or hepatic disease.
    • Ventilated subjects, and those with unstable neurological diseases.
    6. Chronic use of:
    • Immunosuppressants (cyclosporine, methotrexate, etc.).
    • Oral steroids therapy.
    • Clopidogrel.
    E.5 End points
    E.5.1Primary end point(s)
    An optimized Sinerem enhanced 3T MRI examination to characterize atherosclerotic
    plaque in the carotid artery.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Methodology Study
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state30
    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.
    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 Decision2008-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-10-29
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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