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    Summary
    EudraCT Number:2016-001464-11
    Sponsor's Protocol Code Number:ALN-AT3SC-004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-08-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-001464-11
    A.3Full title of the trial
    ATLAS-A/B: A Phase 3 study to evaluate the efficacy and safety of fitusiran in patients with hemophilia A or B, without inhibitory antibodies to factor VIII or IX
    ATLAS-A/B: Estudio de fase 3 para evaluar la eficacia y la seguridad de fitusirán en pacientes con hemofilia A o B sin anticuerpos inhibidores de los factores VIII o IX
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of fitusiran (ALN-AT3SC) in hemophilia A and B patients without inhibitors
    Estudio de Fitusirán (ALN-AT3SC) en pacientes con hemofilia A y B sin inhibidores
    A.4.1Sponsor's protocol code numberALN-AT3SC-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 Trials 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
    B.5.6E-mailclinicaltrials@alnylam.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1297; EU/3/14/1298
    D.3 Description of the IMP
    D.3.1Product namefitusiran
    D.3.2Product code ALN-AT3SC
    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 INNfitusiran
    D.3.9.1CAS number 1609016-97-8
    D.3.9.2Current sponsor codeALN-AT3SC
    D.3.9.3Other descriptive nameALN-57213
    D.3.9.4EV Substance CodeSUB130859
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Hemophilia A or Hemophilia B
    Hemofilia A o Hemofilia B
    E.1.1.1Medical condition in easily understood language
    Hemophilia is an inherited bleeding disorder in which the blood does not clot normally and can result in internal bleeding into the muscles and joints.
    La hemofilia es un trastorno hemorrágico hereditario en el que la sangre no coagula normalmente y puede dar lugar a sangrado interno en los músculos y las articulaciones.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10060613
    E.1.2Term Hemophilia A (Factor VIII)
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10060614
    E.1.2Term Hemophilia B (Factor IX)
    E.1.2System Organ Class 100000004850
    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 efficacy of fitusiran compared to on demand treatment with factor concentrates, as determined by the frequency of bleeding episodes.
    Evaluar la eficacia de fitusirán en comparación con el tratamiento a demanda con concentrados de factores, determinada por la frecuencia de episodios hemorrágicos
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of fitusiran compared to on demand treatment with factor concentrates, as determined by the frequency of spontaneous bleeding episodes, the frequency of joint bleeding episodes in patients, and health related quality of life (HRQOL) in patients receiving fitusiran.
    Evaluar la eficacia de fitusirán en comparación con el tratamiento a demanda con concentrados de factores, determinada por la frecuencia de episodios hemorrágicos espontáneos, la frecuencia de episodios hemorrágicos articulares y la calidad de vida relacionada con la salud (CVRS) en pacientes que reciban fitusirán.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males ≥12 years of age.

    Severe hemophilia A or B (evidenced by a central laboratory FVIII <1% or FIX level ≤2% at Screening) without inhibitors (evidenced by inhibitor titer of <0.6 BU/mL and supported by medical records)

    AT activity ≥60% at Screening

    A minimum of 6 bleeding episodes requiring factor concentrate treatment within the last 6 months

    Willing and able to comply with the study requirements and to provide written informed consent and assent in the case of patients under the age of legal consent
    Varones de ≥ 12 años de edad.

    Hemofilia A o B grave (demostrada mediante medición en el laboratorio central de FVIII < 1 % o FIX ≤ 2 % en la selección) sin inhibidores (demostrado por un título de inhibidores < 0,6 BU/ml documentado en la historia clínica)

    Actividad AT ≥ 60 % en la selección

    Mínimo de 6 episodios hemorrágicos con necesidad de tratamiento con concentrados de factores en los 6 meses previos.

    Disposición y capacidad para cumplir los requisitos del estudio y para otorgar el consentimiento informado por escrito y el asentimiento en el caso de los menores de edad para dar el consentimiento.
    E.4Principal exclusion criteria
    1. Known co-existing bleeding disorders other than hemophilia A or B, ie, Von
    Willebrand’s disease, additional factor deficiencies, or platelet disorders.
    2. Current use of factor concentrates as regularly administered prophylaxis designed to
    prevent spontaneous bleeding episodes.
    3. AT activity <60% at Screening as determined by central laboratory measurement.
    4. Presence of clinically significant liver disease, or as indicated by any of the conditions
    below:
    a. INR >1.2;
    b. ALT and/or AST >1.5× upper limit of normal reference range (ULN);
    c. Total bilirubin >ULN (>1.5 ULN in patients with Gilbert’s Syndrome);
    d. History of portal hypertension, esophageal varices, or hepatic encephalopathy;
    e. Presence of ascites by physical exam
    5. Hepatitis C virus antibody positive, except patients with a history of HCV infection who
    meet both conditions a. and b.:
    a. Completed curative treatment at least 12 weeks prior to enrollment and attained
    sustained virologic response as documented by a negative HCV RNA at screening, or
    they have spontaneously cleared infection as documented by negative HCV RNA at
    Screening.
    b. No evidence of cirrhosis according to one of the following assessments:
     FibroScan <12.5 kPa (where available), or
     FibroTest score <0.75 and APRI <2 (if FibroScan unavailable)
    6. Presence of acute hepatitis, ie, hepatitis A, hepatitis E.
    7. Presence of acute or chronic hepatitis B infection (IgM anti-HBc antibody positive or
    HBsAg positive).
    8. Platelet count ≤100,000/μL.
    9. Presence of acute infection at Screening.
    10. Known to be HIV positive with CD4 count <200 cells/μL.
    11. Estimated glomerular filtration rate ≤45 mL/min/1.73m2 (using the Modification of Diet
    in Renal Disease [MDRD] formula).
    12. Co-existing thrombophilic disorder, as determined by presence of any of the below as
    identified at central laboratory (or via historical results, where available):
    a. FV Leiden (homozygous or heterozygous)
    b. Protein S deficiency
    c. Protein C deficiency
    d. Prothrombin mutation (G20210A; homozygous or heterozygous)
    13. History of antiphospholipid antibody syndrome.
    14. History of arterial or venous thromboembolism, atrial fibrillation, significant valvular
    disease, myocardial infarction, angina, transient ischemic attack, or stroke. Patients who
    have experienced thrombosis associated with indwelling venous access may be enrolled.
    15. Had a malignancy within 2 years, except for basal or squamous cell carcinoma of the skin
    that has been successfully treated.
    16. Any condition (eg, medical concern), which in the opinion of the Investigator, would
    make the patient unsuitable for dosing on Day 1 or which could interfere with the study
    compliance, the patient’s safety and/or the patient’s participation in the completion of the
    treatment period of the study. This includes significant active and poorly controlled
    (unstable) cardiovascular, neurologic, gastrointestinal, endocrine, renal or psychiatric
    disorders unrelated to hemophilia identified by key laboratory abnormalities or medical
    history.
    17. At Screening, anticipated need of surgery during the study or planned surgery scheduled
    to occur during the study.
    18. Completion of a surgical procedure within 14 days prior to Screening, or currently
    receiving additional factor infusion for postoperative hemostasis.
    19. History of multiple drug allergies or history of allergic reaction to an oligonucleotide or
    GalNAc.
    20. Inadequate venous access, as determined by the Investigator, to allow the blood draws
    required by the study protocol.
    21. History of intolerance to SC injection(s).
    22. Current or future participation in another clinical study, scheduled to occur during this
    study, involving an investigational product other than fitusiran or investigational device;
    in order to participate in this study, patient must discontinue the investigational product at
    least 30 days (or 5× the investigational product half-life, whichever is longer) prior to
    dosing (Day 1).
    23. Current or prior participation in a gene therapy trial.
    24. History of alcohol abuse within the 12 months before Screening. Alcohol abuse is
    defined as regular weekly intake of more than 14 units (unit: 1 glass of wine
    [approximately 125 mL] = 1 measure of spirits (approximately 1 fluid ounce) = ½ pint of
    beer [approximately 284 mL]).
    1. Trastornos hemorrágicos coexistentes conocidos distintos de la hemofilia A o B, es decir,
    enfermedad de Von Willebrand, otras carencias de factores o trastornos de las plaquetas.
    2. Uso actual de concentrados de factores como tratamiento profiláctico habitual destinado a
    evitar episodios hemorrágicos espontáneos.
    3. Actividad AT < 60 % en la selección, según la medición del laboratorio central.
    4. Presencia de hepatopatía clínicamente significativa, o como indique cualquiera de las
    circunstancias siguientes:
    a. INR > 1,2;
    b. ALT/AST > 1,5 × límite superior de la normalidad (LSN);
    c. Bilirrubina total > LSN (> 1,5 LSN en pacientes con síndrome de Gilbert);
    d. Antecedentes de hipertensión portal, varices esofágicas o encefalopatía hepática;
    e. Presencia de ascitis constatada en la exploración física.
    5. Positivo para anticuerpos contra el virus de la hepatitis C, salvo los pacientes con
    antecedentes de infección por el VHC que cumplas las condiciones a. y b.:
    a. Tratamiento curativo finalizado al menos 12 semanas antes de la inscripción y
    consecución de respuesta virológica sostenida, documentada por un ARN del VHC
    negativo en la selección, o desaparición espontánea de la infección documentada por
    un ARN del VHC negativo en la selección.
    b. Ausencia de indicios de cirrosis según una de las evaluaciones siguientes:
     FibroScan < 12,5 kPa (si está disponible), o
     Puntuación de FibroTest < 0,75 y APRI < 2 (si FibroScan no está disponible)
    6. Presencia de hepatitis aguda, es decir, hepatitis A, hepatitis E.
    7. Presencia de infección aguda o crónica por el virus de la hepatitis B (positivo para
    HBsAg o positivo para el anticuerpo IgM anti-HBc).
    8. Recuento de plaquetas ≤ 100. 000/μl.
    9. Presencia de infección aguda en la selección.
    10. VIH positivo con recuento de CD4 < 200 células/μl.
    11. Filtración glomerular estimada ≤ 45 ml/min/1,73 m2 (empleando la fórmula de la
    Modificación de la dieta en enfermedad renal [MDRD]).
    12. Trastorno trombofílico coexistente, determinado por la presencia de cualquiera de lo
    siguiente identificado en el laboratorio central (o por los resultados históricos, si se
    dispone de ellos):
    a. Mutación del FV Leiden (homocigótica o heterocigótica)
    b. Deficiencia de proteína S
    c. Deficiencia de proteína C
    d. Mutación de la protrombina (G20210A; homocigótica o heterocigótica)
    13. Antecedentes de síndrome de anticuerpos antifosfolípidos.
    14. Antecedentes de tromboembolia arterial o venosa, fibrilación auricular, valvulopatía
    importante, infarto de miocardio, angina, accidente isquémico transitorio o derrame
    cerebral. Podrán participar pacientes que hayan sufrido una trombosis relacionada con un
    acceso venoso permanente.
    15. Neoplasia maligna en los 2 años anteriores, salvo carcinoma basocelular o espinocelular
    de la piel tratado con éxito.
    16. Cualquier trastorno (p. ej. , enfermedad) que, en opinión del investigador, motive que el
    paciente no sea adecuado para la administración de la medicación el día 1 o que pueda
    dificultar el cumplimiento del estudio, la seguridad del paciente o la participación del
    paciente en el período de tratamiento del estudio. Esto incluye trastornos
    cardiovasculares, neurológicos, digestivos, endocrinos, renales o psiquiátricos
    importantes activos y mal controlados (inestables) no relacionados con la hemofilia,
    identificados mediante la historia médica o alteraciones analíticas fundamentales.
    17. En la selección, necesidad prevista de una intervención quirúrgica durante el estudio o
    intervención quirúrgica programada durante el estudio.
    18. Realización de un procedimiento quirúrgico en los 14 días anteriores a la selección o
    tratamiento actual adicional con infusión de factores para hemostasia posquirúrgica.
    19. Antecedentes de alergias múltiples a fármacos o antecedentes de reacción alérgica a un
    oligonucleótido o a GalNAc.
    20. Acceso venoso inadecuado, en opinión del investigador, para hacer las extracciones de
    sangre exigidas por el protocolo de estudio.
    21. Antecedente de intolerancia a inyecciones s. c.
    22. Participación actual o futura en otro estudio clínico, que se vaya a producir durante este
    estudio, con un medicamento experimental distinto de fitusirán o un producto sanitario
    experimental; para poder participar en este estudio, el paciente debe suspender el
    medicamento en investigación al menos 30 días (o 5 × la semivida del fármaco
    experimental, lo que suponga más tiempo) antes de la administración (día 1).
    23. Participación actual o previa en un ensayo de genoterapia.
    24. Antecedente de alcoholismo en los 12 meses previos a la selección. El alcoholismo se
    define como el consumo semanal regular de más de 14 unidades (unidad: 1 vaso de vino
    [unos 125 ml] = una bebida de alta graduación (unos 30 ml) = 284 ml de cerveza.
    E.5 End points
    E.5.1Primary end point(s)
    Annualized bleeding rate (ABR)
    Tasa de hemorragias anualizada (THA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through 9 months
    Durante 9 meses
    E.5.2Secondary end point(s)
    Annualized Bleeding rate in the treatment period
    Annualized Spontaneous Bleeding rate in the efficacy period
    Annualized joint bleeding rate in the efficacy period
    Change in Haem-A-QOL score in the treatment period
    Annualized Bleeding rate in the onset period
    Tasa de hemorragias anualizada en el periodo de tratamiento
    Tasa de hemorragias espontáneas anualizada en el periodo de eficacia
    Tasa de hemorragias articulares anualizada en el periodo de eficacia
    Cambio en la puntuación Haem-A-QoL en el periodo de tratamiento
    Tasa de hemorragias anualizada en el periodo de arranque
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through 9 months
    Durante 9 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento de rescate estándar
    Rescue SOC
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Australia
    Brazil
    Bulgaria
    Canada
    China
    Denmark
    France
    Germany
    Hungary
    India
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Netherlands
    Portugal
    Russian Federation
    South Africa
    Spain
    Taiwan
    Turkey
    Ukraine
    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
    LVLS
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject must provide written informed consent and assent in the case of patients under the age of legal consent.
    El paciente deberá proporcionar consentimiento informado por escrito y asentimiento en el caso de pacientes menores para dar el consentimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 120
    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)
    Consistent with pre-study treatment.
    De acuerdo con el tratamiento previo al estudio.
    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 Decision2018-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-07-14
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