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    Summary
    EudraCT Number:2019-001599-12
    Sponsor's Protocol Code Number:ASC-Man-P016
    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:2019-07-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-001599-12
    A.3Full title of the trial
    A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients with Known or Suspected Focal Liver Lesions and Severe Renal Impairment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients with Known or Suspected Focal Liver Lesions and Severe Renal Impairment
    A.3.2Name or abbreviated title of the trial where available
    SPARKLE
    A.4.1Sponsor's protocol code numberASC-Man-P016
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAscelia Pharma AB
    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 supportAscelia Pharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAscelia Pharma AB
    B.5.2Functional name of contact pointMarie Källström
    B.5.3 Address:
    B.5.3.1Street AddressHyllie Boulevard 34
    B.5.3.2Town/ cityMalmö
    B.5.3.3Post code215 32
    B.5.3.4CountrySweden
    B.5.4Telephone number+46735179120
    B.5.6E-mailmk@ascelia.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 Mangoral
    D.3.4Pharmaceutical form Powder for oral solution in sachet
    D.3.4.1Specific paediatric formulation No
    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 INNMangoral
    D.3.9.1CAS number 13446-34-9
    D.3.9.2Current sponsor codeMangoral (CMC-001)
    D.3.9.3Other descriptive nameMANGANESE CHLORIDE TETRAHYDRATE
    D.3.9.4EV Substance CodeSUB27073
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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 typeExtractive. The origin of the active substance is from mined ore.
    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
    MRI in terms of visualization of detected focal liver lesions in patients with known or Suspected focal liver lesions and severe renal impairment
    E.1.1.1Medical condition in easily understood language
    Magnetic resonance Imaging of the liver
    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 22.1
    E.1.2Level LLT
    E.1.2Classification code 10028049
    E.1.2Term MRI
    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 assess the diagnostic efficacy of Mangoral in liver MRI in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.
    Lesion visualization will be determined by qualitative assessments of lesion border delineation and lesion contrast compared to background liver on 4-point scales for up to 15 lesions per patient.
    E.2.2Secondary objectives of the trial
    • To assess the diagnostic efficacy of Mangoral in liver MRI in terms of:
    - no. lesions detected by each MRI method;
    - visualization of detected focal liver lesions in Mangoral-enhanced MRI comp. to unenhanced MRI;
    - confidence in lesion detection and localization in each MRI method;
    - lesion dimensions...
    - quantitative assessments … signal intensity enhancement of liver, liver-to-lesion contrast, signal-to-noise ratio, contrast-to-noise ratio - up to 5 lesions/pat.;
    - no. of patients who had at least 1 new lesion identified on CMRI compared to unenhanced MRI
    • To assess a proportion of pat. having at least 1 malignant lesion identified on postmangoral images that was not identified on pre-mangoral images.
    • To evaluate the safety and tolerability of Mangoral;
    • To evaluate the pharmacokinetics of manganese after a single dose of Mangoral in a subgroup of pat.
    • To evaluate the impact of diagnostic performance of CMRI and Mangoral-enhanced MRI versus unenhanced MRI ...
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female patients 18 years and older

    Known or suspected focal liver lesions based on medical history and previous laboratory and/or imaging examinations

    Severe renal impairment such as:
    a. Chronic kidney disease [CKD] (estimated glomerular filtrationrate [eGFR] < 30 mL/min/1.73 m2) based on medical history and previous laboratory examinations at least once within the last 3 month prior to the Baseline Visit, OR
    b. Acute kidney injury (AKI) with an increase in serum creatinine ≥ 0.3 mg/dL within 48 hours or ≥ 50% within 7 days prior to the Baseline visit
    E.4Principal exclusion criteria
    Patients with simple liver cysts only
    Any investigational drug or device within 6 weeks prior to the Baseline Visit.
    Any MRI contrast media within 6 weeks prior to Baseline Visit or scheduled to receive any contrast medium before the last study visit.
    Patients with severe hepatic impairment (according to Child-Pugh score C).
    Patients scheduled for surgery before last study visit.
    Patients with encephalopathy / neurodegenerative or acute neurological disorders.
    Patients with hemochromatosis
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the visualization of detected focal liver lesions in combined MRI (CMRI, Mangoral-enhanced MRI plus unenhanced MRI) as compared to unenhanced MRI.
    Efficacy will be assessed by testing the superiority of each of the 2 co-primary variables:
    • lesion border delineation (BD), and
    • lesion contrast compared to liver background (LC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessments will be done during central reading sessions.
    All unenhanced and Mangoral-enhanced MRI image sets will be evaluated centrally at the imaging core lab by 3 independent readers.
    The central evaluation of all MRI images will consist of 3 parts:
    • Part I: unenhanced MRI alone;
    • Part II: combined MRI, i.e. paired reading of both unenhanced and Mangoral-enhanced images;
    • Part III: Mangoral-enhanced MRI alone.
    Each of the 3 independent readers will assess all images of all patients in each part of the reading. There will be a 2-weeks gap between read parts to reduce recall bias.
    The analysis of the primary efficacy variable will be based on the qualitative assessments performed centrally at the imaging core lab.
    E.5.2Secondary end point(s)
    - Number of lesions detected by each MRI method: unenhanced MRI, Mangoral-enhanced MRI, and CMRI.
    - Visualization of focal liver lesions in Mangoral-enhanced MRI as compared to unenhanced MRI
    - Confidence in lesion detection separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI
    - Confidence in lesion localization separately in unenhanced MRI, Mangoral-enhanced MRI, and CMRI
    - Lesion dimensions
    - Quantitative assessments
    - Change(s) in patients’ management based on diagnostic performance of CMRI or Mangoral-enhanced MRI vs. unenhanced MRI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessments will be done during central reading sessions as described in E.5.1.1.
    Additionally on-site evaluation will be done by each site investigator (or on-site radiologist) at the respective study site and will include separate assessments of all unenhanced and Mangoral-enhanced images of each patient. Data of on-site assessments will be used for analysis of specific secondary efficacy variables.
    In addition, brain MRI images will be evaluated by the independent off-site radiologist. Offsite evaluations should be performed within 5 working days after the respective MRI examination.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Central evaluation by 3 independent readers
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Unenhanced MRI will serve as control
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Argentina
    Colombia
    Mexico
    Russian Federation
    United States
    Germany
    Italy
    Poland
    Sweden
    Türkiye
    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 months8
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    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.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state38
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 97
    F.4.2.2In the whole clinical trial 197
    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 - Upon completion of the trial, patients should be treated at the discretion of the treating physician.
    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 Decision2019-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-27
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