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    Summary
    EudraCT Number:2021-003158-21
    Sponsor's Protocol Code Number:MGNT2022
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-11-04
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2021-003158-21
    A.3Full title of the trial
    MAGNETICAL: MAGNetic resonance Evaluation of Tafamidis Impact in Cardiac AmyLoidosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessing tafamidis impact in patients with Cardiac Amyloidosis using magnetic ressonance imaging
    A.3.2Name or abbreviated title of the trial where available
    MAGNETICAL
    A.4.1Sponsor's protocol code numberMGNT2022
    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 SponsorCentro Hospitalar de Trás-os-Montes e Alto Douro (CHTMAD), EPE
    B.1.3.4CountryPortugal
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLaboratórios Pfizer
    B.4.2CountryPortugal
    B.4.1Name of organisation providing supportSociedade Portuguesa de Cardiologia
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentro Hospitalar de Trás-os-Montes e Alto Douro (CHTMAD), EPE
    B.5.2Functional name of contact pointCatarina Ferreira
    B.5.3 Address:
    B.5.3.1Street AddressAvenida da Noruega, Lordelo
    B.5.3.2Town/ cityVila Real
    B.5.3.3Post code5000-508
    B.5.3.4CountryPortugal
    B.5.4Telephone number351916418717
    B.5.6E-mailcatarina.m.ferreira.cf@gmail.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 Vyndaqel
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/12/1066
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, soft
    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 INNTafamidis
    D.3.9.1CAS number 594839-88-0
    D.3.9.3Other descriptive name2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid
    D.3.9.4EV Substance CodeSUB33016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number61
    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
    TTR amyloidosis (wild type or hereditary)
    E.1.1.1Medical condition in easily understood language
    cardiac amyloidosis
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007509
    E.1.2Term Cardiac amyloidosis
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the evolution and correlation of CMR imaging parameters before and after treatment with tafamidis for 12 months.
    E.2.2Secondary objectives of the trial
    To identify clinical, analytical and imaging predictors of treatment response.
    To assess the association of imaging markers evolution with mortality and heart failure related hospitalizations.
    To assess the association of imaging markers evolution with functional capacity and quality of life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Established diagnosis of TTR amyloidosis (wild type or hereditary) in accordance with institutional/site standard of care (SoC):
    - Diphosphonate scintigraphy with 99mTc-labelled radiotracers (grade 2 or 3 uptake) AND cardiac involvement confirmed by means of echocardiography, with an end-diastolic interventricular septal wall thickness exceeding 12 mm AND no evidence of a monoclonal protein by negative serum free light chain and negative serum and urine
    immunofixation OR
    - Extracardiac biopsy positive for ATTR amyloidosis AND cardiac involvement confirmed by means of echocardiography, with an enddiastolic interventricular septal wall thickness exceeding 12 mm OR
    - Cardiac biopsy positive for ATTR amyloidosis

    AND
    • Medical history of heart failure - NYHA I-III
    • Age > 18 years and < 90 at screening
    • Capable of providing written informed consent, willing and able to adhere to protocol requirements
    • Patients with or without renal failure will also be included (for those with stage 4/5 CKD no late gadolinium enhancement will be performed)
    • Able to comply with approved Summary of Product Characteristics recommendations for treatment with tafamidis 61mg
    E.4Principal exclusion criteria
    • Confirmed diagnosis of light-chain amyloidosis
    • Familial amyloid polyneuropathy
    • NYHA IV
    • Heart failure due to other condition than CA in the opinion of the investigator
    • History of liver or cardiac transplant
    • Previous treatment with tafamidis or other alternatives in transthyretin amyloidosis
    • Severe malnutrition
    • Implanted cardiac device – pacemaker, defibrillator, cardiac resynchronization therapy
    • Devices or other material non-MRI conditional
    • Liver transaminases > 2 upper normal limit
    • Participating in another investigational study
    • Subjects requiring treatment with calcium channel blockers or digitalis
    • Subjects using non-steroidal anti-inflammatory drugs (NSAIDS), tauroursodeoxycholate and doxycycline
    • Investigator determines that the subject is not suitable for study participation for any other reason
    • Subjects who are pregnant females; breastfeeding females; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days, after last dose of tafamidis
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline at each point in CMR imaging parameters, including:
    ventricular volumes, mass, ejection fraction; native T1 and T2 mapping; ECV; Look-Locker at 2, 5 and 10 minutes; LGE, Strain analysis and 4D flow;
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change from baseline
    E.5.2Secondary end point(s)
    Frequency of heart failure related hospitalization and all-cause mortality
    Change from baseline at each point in the Kansas City Cardiomyopathy
    Questionnaire overall score
    Change from baseline at each point in 6MWT distance
    Change from baseline at each point in NT-proBNP concentration
    Change from baseline at each point in NYHA classification
    Change from baseline at each point in echocardiographic parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change from baseline
    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 Yes
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned3
    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 No
    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 months7
    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 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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 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)
    Patients will receive supportive care according to their concomitant comorbidities. At the end of the trial, patients will be able to switch to Tafamidis, provided by the Hospital. The decision on treatment with Tafamidis at the end of the study will be evaluated on a case-by-case basis.
    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 Decision2023-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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