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    EudraCT Number:2014-003835-20
    Sponsor's Protocol Code Number:ALN-TTRSC-004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-14
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-003835-20
    A.3Full title of the trial
    A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)
    Estudio de fase 3, multicéntrico, internacional, aleatorizado,
    doble ciego, controlado con placebo para evaluar la eficacia y la
    seguridad de ALN-TTRSC en pacientes con miocardiopatía
    amiloide familiar (CAF) relacionada con transtiretina (TTR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart
    Estudio para analizar la eficacia y seguridad de ALN TTRSC en pacientes con una enfermedad hereditaria que provoca que ciertas moléculas de proteína se depositen en el corazón
    A.4.1Sponsor's protocol code numberALN-TTRSC-004
    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 SponsorAlnylam Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportAlnylam Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlnylam Pharmaceuticals Inc
    B.5.2Functional name of contact pointClinical Trial Hotline
    B.5.3 Address:
    B.5.3.1Street Address300 Third Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1267 (EMA/OD/194/13)
    D.3 Description of the IMP
    D.3.1Product nameALN-TTRSC
    D.3.2Product code ALN-TTRSC
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.2Current sponsor codeALN-TTRSC
    D.3.9.3Other descriptive nameALN-51547
    D.3.9.4EV Substance CodeSUB104164
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
    Tratamiento de pacientes con MAF mediada por la TTR
    E.1.1.1Medical condition in easily understood language
    FAC is a hereditary disease caused by protein aggregates in the heart. It leads to heart dysfunction, conduction defects, arrhythmias, congestive heart failure and death.
    MAF es una enfermedad hereditaria causada por agregados de proteínas en el corazón. Que lleva a la disfunción del corazón, defectos de conducción, arritmias, insuficiencia cardíaca congestiva y muerte
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10016202
    E.1.2Term Familial amyloidosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 determine the efficacy of ALN-TTRSC in patients with FAC.
    Determinar la eficacia de ALN-TTRSC en pacientes con MAF.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are male or female of 18 to 90 years of age (inclusive).

    2. Have a documented TTR mutation.

    3. Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red staining.

    4. If patient has monoclonal gammopathy, TTR amyloidosis needs to be confirmed through either TTR protein identification via immunohistochemistry or mass spectrometry OR Technetium scintigraphy (99mTc -3,3-diphosphono-1,2-propanodicarboxylic acid
    [DPD-Tc] or 99m-Tc-Pyrophosphate [PYP-Tc]).

    5. Have a medical history of heart failure (HF) with at least 1 prior hospitalization for HF, which may include hospitalization for arrhythmia or pacemaker placement, OR clinical evidence of HF (as evidenced by one or more of the following: elevated jugular venous
    pressure, peripheral edema, shortness of breath or signs of pulmonary congestion on x-ray or auscultation) that either requires/required treatment with diuretics or is/was associated with an N terminal prohormone of B-type natriuretic peptide (NT-proBNP) >400 ng/L or
    B-type natriuretic peptide (BNP) >100 ng/L.

    6. Have evidence of cardiac involvement by Screening/Baseline echocardiogram including an end-diastolic intraventricular septum thickness of ?12 mm. For patients with an end-diastolic intraventricular septum thickness of <12mm, an endomyocardialbiopsy showing amyloid deposition is required.

    7. Can walk ?150 meters on a 6-minute walk test (6-MWT).

    8. Have a Karnofsky performance status of ?50%.

    9. Symptoms of HF optimally managed with no CV hospitalizations within 4 weeks prior to consent or during Screening/Baseline.

    10. Have adequate liver function, demonstrated by an aspartate transaminase (AST) and alanine transaminase (ALT) ?2.5 × the upper limit of normal (ULN), albumin >3 g/dL (>4.35 ?mol/L), and total bilirubin <2 mg/dL (34.2 ?mol/L), unless elevation in total bilirubin is
    due to Gilbert?s syndrome.

    11. No active infection with hepatitis B (HBV) or hepatitis C (HCV) by serology.

    12. Women of child-bearing potential must have a negative pregnancy test, cannot be breastfeeding, and use 2 highly effective methods of contraception throughout study participation, and for 28 days after last dose of study drug.

    13. Males with partners of child-bearing potential, must agree to use 1 barrier method (e.g., condom) and 1 additional method (eg, spermicide) of contraception throughout study participation and for 28 days after the last dose of study drug; males must also abstain from sperm donation after the first dose of study drug through study participation and for 28 days after the last dose of study drug.

    14. Must be willing and able to comply with protocol-required visit schedule and visit requirements and provide informed consent or have a legal guardian who can provide informed consent.
    1. Pacientes de ambos sexos de 18 a 90 años de edad (inclusive).
    2. Mutación documentada en TTR.
    3. Confirmación de la presencia de depósitos de amiloide en tejido cardíaco y no cardíaco mediante tinción con Rojo Congo.
    4. En caso de gammapatía monoclonal, la amiloidosis por TTR debe confirmarse mediante la identificación de la proteína TTR con inmunohistoquímica o espectrometría de masas O gammagrafía con tecnecio (ácido 3,3-difosfono-1,2-propanodicarboxílico marcado con tecnecio99m [DPD-Tc] o pirofosfato marcado con tecnecio99m [PYP-Tc]).
    5. Antecedentes médicos de insuficiencia cardíaca (IC) con al menos 1 ingreso hospitalario previo por IC, que puede incluir hospitalización debido a una arritmia o para la implantación de un marcapasos, O evidencia clínica de IC (definida por uno o más de los siguientes: presión venosa yugular elevada, edema periférico, dificultad para respirar o signos de congestión pulmonar en radiografía o auscultación) que requiera/haya requerido tratamiento con diuréticos o esté/haya estado asociada a una concentración de prohormona N-terminal del péptido natriurético tipo-B (NT-proBNP)>400 ng/l o de péptido natriurético tipo-B (BNP)>100 ng/l.
    6. Signos de afectación cardíaca en un ecocardiograma realizado en la visita de selección/inicial que incluya un espesor del tabique intraventricular de fin de diástole ?12 mm. En el caso de los pacientes con espesor del tabique intraventricular de fin de diástole <12 mm, se requiere una biopsia endomiocárdica que muestre depósitos de amiloide.
    7. Poder caminar una distancia ?150 metros en una prueba de marcha durante 6 minutos (6-MWT).
    8. Estado funcional según el índice de Karnofsky ?50 %.
    9. Síntomas de IC controlada de forma óptima sin ingresos hospitalarios por problemas cardiovasculares (CV) en las 4 semanas anteriores al consentimiento o durante la visita de selección/inicial.
    10. Función hepática adecuada, demostrada mediante concentraciones de aspartato transaminasa (AST) y alanina transaminasa (ALT) ?2,5 veces el límite superior de la normalidad (LSN), albúmina >3 g/dl (>4,35 ?mol/l) y bilirrubina total <2 mg/dl (34,2 ?mol/l), a menos que el aumento de la bilirrubina total se deba al síndrome de Gilbert.
    11. No presentar una infección activa por hepatitis B (VHB) o hepatitis C (VHC) demostrada mediante serología.
    12. Las mujeres en edad fértil deben tener un resultado negativo en la prueba de embarazo, no pueden estar en período de lactancia y deben usar 2 métodos anticonceptivos altamente eficaces (consúltese la Sección 5.2) durante toda la participación en el estudio y durante 28 días después de la última dosis del medicamento del estudio.
    13. Los varones con parejas en edad fértil deben aceptar usar un método anticonceptivo de barrera (por ejemplo, preservativo) y otro método anticonceptivo adicional (por ejemplo, espermicida) durante toda la participación en el estudio y durante 28 días después de la última dosis del medicamento del estudio. Los varones también deben abstenerse de donar esperma después de la primera dosis del medicamento del estudio durante toda la participación en el estudio y durante 28 días después de la última dosis del medicamento del estudio
    14. Estar dispuesto y querer cumplir con el calendario de visitas requerido por el protocolo y los requisitos de las visitas, y proporcionar el consentimiento informado o tener un tutor legal que pueda proporcionar el consentimiento informado.
    E.4Principal exclusion criteria
    1. Has estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m2 (using the Modification of Diet in Renal Disease [MDRD] formula)

    2. Has known primary amyloidosis (AL), leptomeningeal amyloidosis, non- FAC hereditary cardiomyopathy, hypertensive cardiomyopathy, or cardiomyopathy due to valvular heart disease

    3. Has known peripheral vascular disease affecting ambulation

    4. Has uncontrolled hypertension

    5. Has uncontrolled ischemic heart disease

    6. Has uncontrolled clinically significant cardiac arrhythmia

    7. Had acute coronary syndrome within the past 3 months

    8. Has a Polyneuropathy Disability score >2

    9. Has untreated hypo- or hyperthyroidism

    10. Has a New York Heart Association (NYHA) classification of IV

    11. Has known or suspected systemic bacterial, viral, parasitic, or fungal infection

    12. Has known human immunodeficiency virus (HIV) infection

    13. Has a known history of alcohol abuse within the last two years

    14. Has received an investigational agent or device within 30 days of anticipated study drug administration or 5 half-lives of the investigational drug, whichever is longer

    15. Is currently taking diflunisal, tafamidis, doxycycline, or tauroursodeoxycholic acid; if previously on any of these agents, must have completed a 14-day wash-out prior to start of study drug administration in this study

    16. Had metastatic cancer within the past 5 years

    17. History of allergic reaction to an oligonucleotide or Nacetylgalactosamine (GalNAc).

    18. Has a history of intolerance to SC injection

    19. Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation
    1. Tasa de filtración glomerular estimada (TFGe) <30 ml/min/1,73 m2 (de acuerdo con la fórmula de modificación de la dieta en la nefropatía [Modification of Diet in Renal Disease, MDRD]).
    2. Amiloidosis (AL) primaria conocida, amiloidosis leptomeníngea, miocardiopatía hereditaria no MAF, miocardiopatía hipertensiva o miocardiopatía debida a una cardiopatía valvular.
    3. Enfermedad vascular periférica conocida que afecte la marcha.
    4. Hipertensión no controlada.
    5. Cardiopatía isquémica no controlada.
    6. Arritmia cardíaca clínicamente significativa no controlada.
    7. Antecedentes de síndrome coronario agudo en los últimos 3 meses.
    8. Puntuación >2 en la discapacidad por polineuropatía.
    9. Hipertiroidismo o hipotiroidismo no tratados.
    10. Clasificación de IV según la Asociación de Cardiología de Nueva York (New York Heart Association, NYHA).
    11. Infección sistémica bacteriana, vírica, parasitaria o micótica conocida o sospechada.
    12. Infección causada por el virus de la inmunodeficiencia humana (VIH) conocida.
    13. Antecedentes conocidos de alcoholismo en los últimos dos años.
    14. Tratamiento con algún dispositivo o medicamento en fase de investigación en los 30 días anteriores a la administración del medicamento del estudio o 5 semividas del medicamento en fase de investigación, lo que sea más largo.
    15. Estar usando actualmente diflunisal, tafamidis, doxiciclina o ácido tauroursodeoxicólico. Si con anterioridad usó alguno de estos medicamentos, debe haber transcurrido un período de reposo farmacológico de 14 días antes de comenzar con la administración del medicamento de este estudio.
    16. Antecedentes de cáncer metastásico en los últimos 5 años.
    17. Antecedentes de reacción alérgica a un oligonucleótido o a la N-acetilgalactosamina (GalNAc).
    18. Antecedentes de intolerancia a inyecciones s.c.
    19. Presencia de otros problemas médicos o enfermedades concomitantes que, según criterio del investigador, afectarían al cumplimiento del estudio o a la interpretación de los datos.
    E.5 End points
    E.5.1Primary end point(s)
    The co-primary endpoints of the study are to evaluate the difference between the ALN-TTRSC and placebo groups for:

    1. Change in 6-MWD at 18 months compared to baseline

    2. Percent reduction in serum TTR burden over 18 months
    Los criterios de valoración coprincipales del estudio son evaluar la diferencia entre los grupos de ALN-TTRSC y placebo respecto a:
    1. Cambio en la prueba 6-MWD a los 18 meses respecto al inicio.
    2. Reducción porcentual de la carga de TTR en suero durante 18 meses.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At 18 months

    2. Over 18 months
    1. A los 18 meses
    2. Durante 18 meses.
    E.5.2Secondary end point(s)
    The secondary endpoints of the study are to determine the effect of ALN-TTRSC on various clinical parameters by assessing the difference between the ALN-TTRSC and placebo groups at 18 months for:

    ? Composite CV mortality and CV hospitalization
    ? Change in New York Heart Association (NYHA) class compared to baseline
    ? Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to baseline
    ? Cardiovascular (CV) mortality
    ? CV hospitalization
    ? All-cause mortality
    Los criterios de valoración secundarios del estudio son determinar el efecto de ALN-TTRSC en distintos parámetros clínicos mediante la evaluación de las diferencias entre los grupos de ALN-TTRSC y placebo a los 18 meses respecto a:
    ? Criterio de valoración compuesto de mortalidad CV e ingresos hospitalarios por causas CV.
    ? Cambio de clase según la Asociación de Cardiología de Nueva York (New York Heart Association, NYHA) respecto al inicio.
    ? Cambio en el Cuestionario de miocardiopatías de Kansas City (Kansas City Cardiomyopathy Questionnaire, KCCQ) respecto al inicio.
    ? Mortalidad cardiovascular (CV).
    ? Ingreso hospitalario por causas CV.
    ? Mortalidad por cualquier causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? At 18 months
    - A los 18 meses.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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. 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 200
    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)
    Eligible patients who complete study dosing and the 18 month efficacy assessments may be eligible to participate in an ALN-TTRSC open-label extension study.
    Los pacientes aptos que completen la administración de dosis del medicamento del estudio y las evaluaciones de eficacia de los 18 meses sean aptos para participar en un estudio de extensión abierto de ALN-TTRSC.
    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 Decision2015-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-30
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