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    Summary
    EudraCT Number:2018-002098-23
    Sponsor's Protocol Code Number:ALN-TTRSC02-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-002098-23
    A.3Full title of the trial
    HELIOS-A: A Phase 3 Global, Randomized, Open-label Study to Evaluate the Efficacy and Safety of ALN-TTRSC02 in Patients with Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)
    HELIOS-A: Estudio de fase 3, internacional, aleatorizado y abierto para evaluar la eficacia y la seguridad de ALN-TTRSC02 en pacientes con amiloidosis hereditaria por transtiretina (amiloidosis hATTR).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HELIOS-A: A Clinical Study to Assess the Effectiveness and Safety of an Investigational Drug, ALN-TTRSC02, in Patients with Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis).
    HELIOS-A: Estudio clinico para evaluar la eficacia y la seguridad de un farmaco en investigacion, ALN-TTRSC02, en pacientes con amiloidosis hereditaria de transtiretina(amiloidosis hATTR).
    A.3.2Name or abbreviated title of the trial where available
    HELIOS-A
    A.4.1Sponsor's protocol code numberALN-TTRSC02-002
    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 Information Line
    B.5.3 Address:
    B.5.3.1Street Address300 Third Street
    B.5.3.2Town/ cityCambridge, Massachusetts
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018772569526
    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/3/18/2026
    D.3 Description of the IMP
    D.3.1Product nameALN-TTRSC02
    D.3.2Product code ALN-TTRSC02
    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 INNvutrisiran
    D.3.9.1CAS number 1867157-35-4
    D.3.9.2Current sponsor codeALN-65492
    D.3.9.3Other descriptive nameALN-65492
    D.3.9.4EV Substance CodeSUB182382
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Onpattro
    D.2.1.1.2Name of the Marketing Authorisation holderAlnylam Netherlands B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/11/857
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPATISIRAN
    D.3.9.2Current sponsor codePatisiran
    D.3.9.3Other descriptive nameALN-TTR02
    D.3.9.4EV Substance CodeSUB189946
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis)
    Amiloidosis hereditaria por transtiretina (amiloidosis hATTR).
    E.1.1.1Medical condition in easily understood language
    hATTR amyloidosis is a hereditary disease caused by protein aggregates in the heart and the nervous system. It leads to heart disease, damage to the nerves, and gut and bladder problems.
    La Amiloidosis hATTR es una enfermedad hereditaria causada por una agregación de proteinas en el corazón y sistema nervioso. Produce disfunción en el corazon, daños en los nervios, vejiga e intestino.
    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 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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10019889
    E.1.2Term Hereditary neuropathic 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-TTRSC02 in patients with hATTR amyloidosis by evaluating the effect on neurologic impairment and on quality of life
    Determinar la eficacia de ALN-TTRSC02 en pacientes con amiloidosis hATTR mediante la evaluación del efecto sobre el deterioro neurológico y la calidad de vida.
    E.2.2Secondary objectives of the trial
    • To determine the efficacy of ALN-TTRSC02 on gait speed, nutritional status, and disability
    • To characterize the effect of ALN-TTRSC02 on serum TTR levels
    • To evaluate patient mortality and hospitalization
    • Determinar la eficacia de ALN-TTRSC02 sobre la velocidad de la marcha, el estado nutricional y la discapacidad.
    • Definir el efecto de ALN-TTRSC02 sobre la concentración sérica de TTR.
    • Evaluar la mortalidad y la hospitalizaciónde los pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female age 18 (or age of legal consent, whichever is older) to 85 years of age
    • Have a diagnosis of hATTR amyloidosis with documented TTR mutation
    • Have an Neuropathy Impairment Score of 5 to 130 (inclusive; this criterion must be met at the Screening Visit 2)
    • Have a Polyneuropathy Disability score of ≤3b (this criterion must be met at the Screening Visit 2)
    • Have a Karnofsky Performance Status (KPS) of ≥60%
    • Patient is willing and able to comply with the study requirements and to provide written informed consent
    • Varón o mujer con una edad comprendida entre los 18 (o edad del consentimiento legal, lo que sea mayor) y 85 años.
    •Diagnóstico de amiloidosis hATTR con mutación documentada de la TTR.
    •Puntuación NIS de entre 5 y 130 (ambos inclusive; este criterio deberá cumplirse en la visita de selección 2).
    •Puntuación PND ≤ 3b (este criterio deberá cumplirse en la visita de selección 2).
    •Estado funcional de Karnofsky (EFK) ≥ 60%.•.El paciente está dispuesto y es capaz de cumplir los requisitos del estudio y de otorgar su consentimiento informado por escrito.
    E.4Principal exclusion criteria
    • Has had a liver transplant or is likely, in the opinion of the Investigator, to undergo liver transplantation during the 18-month Treatment Period of the study
    • Has known other (non-hATTR) forms of amyloidosis or clinical evidence of leptomeningeal amyloidosis
    • Has a New York Heart Association heart failure classification >2
    • Has any of the following laboratory parameter assessments:
    a. ALT and/or AST >1.5× upper limit of normal reference range (ULN);
    b. Total bilirubin >ULN (>1.5 ULN in patients with Gilbert's Syndrome)
    c. INR >1.2 (patients on anticoagulant therapy with an INR of ≤3.5 will be allowed)
    • Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2
    • Has known human immunodeficiency virus (HIV) infection; or evidence of acute or chronic hepatitis C virus (HCV) or hepatitis B virus (HBV) infection
    • Has other known causes of sensorimotor or autonomic neuropathy (eg, autoimmune disease, monoclonal gammopathy) that the treating physician believes to be contributing to the neuropathy
    • Current or future participation in another investigational device or drug study
    • Is currently taking tafamidis, doxycycline, or tauroursodeoxycholic acid; acid; if previously on
    any of these agents, must have completed a 14-day wash-out prior to dosing (Day 1)
    • Is currently taking diflunisal; if previously on this agent, must have at least a 3-day washout prior to dosing (Day 1)
    •Ha tenido un trasplante de hígado o es probable que, en opinión del investigador, se someta a un trasplante de hígado durante los 18 meses del período de tratamiento.
    • El paciente tiene otras formas conocidas (distintas de hATTR) de amiloidosis o signos clínicos de amiloidosis leptomeníngea.
    • El paciente tiene una insuficiencia cardiaca > 2 según la New York Heart Association.
    • Presencia de alguno de los parámetros analíticos siguientes:
    a.ALT o AST > 1,5 veces el límite superior del intervalo de referencia normal (LSN).
    b.Bilirrubina total > LSN (> 1,5 veces el LSN en los pacientes con síndrome de Gilbert).
    c.Índice internacional normalizado (INR) > 1,2 (se permitirá la participación de pacientes en tratamiento anticoagulante con un INR ≤ 3,5).
    • Filtración glomerular estimada (FGe) ≤ 30 ml/min/1,73 m2
    • Infección conocida por el virus de la inmunodeficiencia humana (VIH) o signos de infección aguda o crónica por el virus de la hepatitis C (VHC) o B (VHB).
    • Presencia de otras causas conocidas de neuropatía sensitivomotora o autonómica (p. ej., enfermedad autoinmunitaria o gammapatía monoclonal) que el médico responsable del tratamiento considera que contribuyen a la neuropatía.
    • Participación actual o futura en otro estudio de un dispositivo o fármaco en investigación.
    • Tratamiento activo con tafamidís, doxiciclina o ácido tauroursodesoxicólico; si el paciente ha recibido previamente cualquiera de estos fármacos, deberá haber completado un período de lavado de 14 días antes de la administración (día 1).
    • Tratamiento activo con diflunisal; si el paciente ha recibido previamente este fármaco, deberá haber completado un período de lavado de tres días, como mínimo, antes de la administración (día 1).
    E.5 End points
    E.5.1Primary end point(s)
    • Change from baseline in the Modified Neurologic Impairment Score +7 (mNIS+7) of the ALN-TTRSC02 group compared to the placebo arm of the Phase 3 patisiran-LNP study (ALN-TTR02-004; APOLLO)
    • Change from baseline in Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QoL-DN) total score of the ALN-TTRSC02 group compared to the placebo arm of the APOLLO study
    •Variación de la puntuación mNIS+7 (Puntuación de deterioro neurológico modificado +7) con respecto al momento basal en comparación con el grupo de placebo del estudio APOLLO.
    • Variación de la puntuación Norfolk QoL-DN (Escala de calidad de vidaNeuropatía diabética de Norfolk) total con respecto al momento basal en comparación con el grupo de placebo del estudio APOLLO.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Change from baseline in the mNIS+7 of the ALN-TTRSC02 group compared to the placebo arm of the APOLLO study at 9 months for the primary analysis, and additional analysis at 18 months
    • Change from baseline in Norfolk Norfolk QoL-DN total score of the ALN-TTRSC02 group compared to the placebo arm of the APOLLO study at 9 months for the primary analysis, and additional analysis at 18 months
    •Variacion de la puntuacion mNIS+7 del grupo ALN-TTRSC02 en comparacion con el grupo placebo del estudo APOLLO a los 9 meses desde el primer analisis, y en el analisis adicional a los 18 meses.
    •Variación de la puntuación Norfolk QoL-DN total del grupo ALN-TTRSC02 en comparacion con el grupo placebo del estudo APOLLO a los 9 meses desde el primer analisis, y en el analisis adicional a los 18 meses.
    E.5.2Secondary end point(s)
    • Change from baseline in the following parameters of the ALN-TTRSC02 group compared to the placebo arm of the APOLLO (patisiran-LNP) study:
    - Timed 10-meter walk test (10-MWT);
    - Modified body mass index (mBMI)
    - Rasch-built Overall Disability Scale (R-ODS)
    • Percent reduction in serum TTR levels in the ALN-TTRSC02 arm compared to the within-study patisiran-LNP arm
    • Composite events of all-cause deaths and/or all-cause hospitalizations in the overall population compared to the placebo arm of the APOLLO study
    • Composite events of all-cause deaths and/or all-cause hospitalizations in patients with cardiac involvement compared to patients with cardiac involvement in the placebo arm of the APOLLO study
    •Variación de los siguientes parámetros desde el nmomento basal del grupo ALN-TTRSC02 en comparación con el grupo de placebo del estudio APOLLO(patisiran-LNP):
    -Prueba cronometrada de marcha de 10 metros..
    -Índice de masa corporal modificado (IMCm).
    -Escala R ODS (Escala de discapacidad general según el modelo de Rasch).
    •Reducción porcentual de la concentración sérica de transtiretina (TTR) en el grupo de ALN-TTRSC02 en comparación con el grupo de patisirán-NPLdel estudio.
    •Episodios combinados de muertes y/ohospitalizaciones por cualquier causa en la población global (durante 18 meses) en comparación con el grupo de placebo del estudio APOLLO.
    •Episodios combinados de muertes y/o hospitalizaciones por cualquier causa en los pacientes con afectación cardíaca (durante 18 meses) en comparación con aquellos con afectación cardíaca del grupo de placebo del estudio APOLLO.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Change from baseline in the various clinical parameters of the ALN-TTRSC02 group compared to the placebo arm of the APOLLO (patisiran-LNP) study at 9 months, and then at 18 months
    • Percent reduction in serum TTR levels in the ALN-TTRSC02 arm compared to the within-study patisiran-LNP arm at 9 months and at 18 months
    • Composite events of all-cause deaths and/or all-cause hospitalizations in the overall population at 18 months
    • Composite events of all-cause deaths and/or all-cause hospitalizations in patients with cardiac involvement at 18 months
    •Variación de los siguientes parámetros con respecto al momento basal del grupo ALN-TTRSC02 en comparación con el grupo de placebo del estudio APOLLO (patisiran-LNP) a los 9 meses y despues a los 18 meses.
    •Reducción porcentual de la concentración sérica de transtiretina (TTR) en el grupo de ALN-TTRSC02 en comparación con el grupo de patisirán-NPLdel estudio a los 9 meses y a los 18 meses.
    •Episodios combinados de muertes y/o hospitalizaciones por cualquier causa en la población global (durante 18 meses)
    •Episodios combinados de muertes y/o hospitalizaciones por cualquier causa en los pacientes con afectación cardíaca (durante 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 No
    E.6.11Pharmacogenomic Yes
    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.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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    External control, with comparison to placebo arm of the Phase 3 APOLLO study of patisiran-LNP
    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
    Placebo arm of completed Phase 3 APOLLO trial by the same sponsor in a similar patient population
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Cyprus
    France
    Germany
    Greece
    Ireland
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    Portugal
    Spain
    Sweden
    Taiwan
    Turkey
    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
    Ultima visita del ultimo 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 months4
    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 months4
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 160
    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)
    After participation in the trial has ended, patients will be treated at the discretion of their physician based on local standard of care.
    Despues de la participacion en el estudio que ha terminado, los pacientes seran tratados a discrecion de su medico segun el estandar de antecion local.
    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 Decision2019-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-14
    P. End of Trial
    P.End of Trial StatusOngoing
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