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    Summary
    EudraCT Number:2005-004176-21
    Sponsor's Protocol Code Number:CMC-P005
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-20
    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 ConcernedSweden - MPA
    A.2EudraCT number2005-004176-21
    A.3Full title of the trial
    Evaluation of the diagnostic efficacy of CMC-001 (MnCl2 tetrahydrate) in MR cholangiography in patients with suspected liver lesions. A randomised, parallel group, open-label Phase II trial.
    A.4.1Sponsor's protocol code numberCMC-P005
    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 SponsorCMC Contrast AB c/o Öresund Health Care Management
    B.1.3.4CountrySweden
    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 Information not present in EudraCT
    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 nameCMC-001
    D.3.2Product code CMC-001
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNManganese chloride tetrahydrate
    D.3.9.1CAS number 13446-34-9
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.6
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Liver lesions. CMC-001 is an orally administered contrast medium containing manganese (Mn) as the active imaging substance. Manganese is absorbed by the healthy parts of the liver and will thus create contrast to liver lesions in MRI.
    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
    The primary objective is to assess the efficacy and the time-response of CMC-001 in 2 dose levels as a contrast medium in MR-cholangiography and to further evaluate the safety and tolerability of CMC-001 in patients.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    - assess if CMC-001-enhanced MR cholangiography provides an equally good or improved image quality of the non-dilated biliary tree in comparison to T2-weighted MR cholangiography.
    - assess and compare the visualization and delineation of focal liver lesions before contrast and after 2.5 and 4 hours after administration of CMC-001.
    - assess the extent to which the pancreatic duct is filled 2.5 and 4 hours post administration of CMC-001
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects may be included in the study if all of the following criteria are fulfilled at the screening visit:
    1. Men or women over 18 years old.
    2. Patients that are referred for MR imaging of the liver for suspected liver pathologies indicated by ultra-sound or CT meriting further investigation.
    3. Signed written informed consent.
    4. The patients are conscious and co-operative.
    E.4Principal exclusion criteria
    If one or more of the following criteria are fulfilled, the subject will not be included in the study:
    1. Medical history or abnormal physical findings which could interfere with the safety or objectives of the study as judged by the investigator.
    2. Clinically relevant haematology, clinical chemistry, serology and urine chemistry abnormalities. This is based on the judgement of the investigator.
    3. Concomitant diseases which can interfere with gastrointestinal absorption e.g. malabsorption, gastrectomi, IBD or major surgical interventions in the GI tract.
    4. Patients who has undergone papillotomy.
    5. Patients who have MR contraindications according to the hospital checklist e.g. pacemaker.
    6. One or more tumour > 10 cm, or several tumours > 5 cm, as judged by ultrasound or CT.
    7. Allergy to any of the study product ingredients.
    8. Drug or alcohol abuse.
    9. Participation in another clinical study concerning pharmaceuticals.
    10. Previous inclusion in this study.
    11. Pregnancy (checked at Visit 2 by pregnancy test when relevant).
    12. Patients scheduled to receive contrast medium intravascularly within 2 days before inclusion or within 3 days after the CMC-001 administration.
    13. Patients with newly discovered unstable diabetes or undergoing haemodialysis or peritoneal dialysis.
    14. Known HIV infection or AIDS.
    15. Confirmed or suspected acute hepatitis.
    16. Bilirubin ≥ 40 µmol/l.
    17. Sepsis
    18. The patient has a non-compensated cardiac failure (cardiac failure NYHA IV).
    19. Patients who are deemed to be unsuitable for any other reason in the opinion of the investigator.

    A patient may be excluded during the trial based on the clinical judgement of the investigator or the radiologist.
    E.5 End points
    E.5.1Primary end point(s)
    The following efficacy endpoints will be drived/assessed from the MR images:
    - Quality of diagnostic information of bile ducts and liver parenchyma.
    - Delineation of the biliary tract and degree of ductal visualization.
    - Signal to noise ratio in the extrahepatic bile duct.
    - Contrast to noise ratio between the extrahepatic bile duct and the liver.
    - Subjective analysis of pre-dosing and post dosing images regarding visualisation of the biliary tract.
    - Subjective analysis of the time-response effect measured by comparing ductal visualisation at the 2.5 and 4 hr images.
    - Subjective analysis of the visualisation and delineation of focal lesions in the liver parenchyma by comparing the 0 hr images with the 2.5 and 4 hr images.
    - Extent of filling of the pancreatic duct.

    Each of these endpoints will be evaluated by means of the MRI equipment.

    The safety endpoints are the number of AEs that are judged to be possibly related to the investigational products.
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Yes
    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 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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-04-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.3.3.6.1Details of subjects incapable of giving consent
    Pregnancy is an exclusion criteria (checked at Visit 2 by pregnancy test)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    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 Decision2006-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
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