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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2020-005061-13
    Sponsor's Protocol Code Number:A011-12
    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:2021-07-08
    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 number2020-005061-13
    A.3Full title of the trial
    An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
    Estudio de seguimiento, abierto, a largo plazo, para evaluar los efectos de sotatercept añadido a la terapia de base de la hipertensión arterial pulmonar (HAP) para el tratamiento de la HAP
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long-term Follow-up Study of Sotatercept for PAH Treatment
    Estudio de seguimiento a largo plazo de sotatercept para el tratamiento de la HAP
    A.3.2Name or abbreviated title of the trial where available
    A Long-term Follow-up Study of Sotatercept for PAH
    Estudio de seguimiento a largo plazo de sotatercept para la HAP
    A.4.1Sponsor's protocol code numberA011-12
    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 SponsorAcceleron Pharma 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 supportAcceleron Pharma Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcceleron Pharma Inc.
    B.5.2Functional name of contact pointSaraBeth Hahn
    B.5.3 Address:
    B.5.3.1Street Address128 Sidney Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900 834 223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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/3/20/2369
    D.3 Description of the IMP
    D.3.1Product nameSotatercept
    D.3.2Product code ACE-011
    D.3.4Pharmaceutical form Lyophilisate for 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 INNSOTATERCEPT
    D.3.9.1CAS number 1001080-50-7
    D.3.9.2Current sponsor codeACE-011
    D.3.9.3Other descriptive nameActRIIA-IgG1Fc
    D.3.9.4EV Substance CodeSUB179718
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Pulmonary Arterial Hypertension (PAH)
    Hipertensión Arterial Pulmonar (HAP)
    E.1.1.1Medical condition in easily understood language
    Cardiovascular Disease
    Enfermedad Cardiovascular
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH.
    El objetivo principal de este estudio abierto de SLP consiste en evaluar la seguridad y la tolerabilidad a largo plazo de sotatercept añadido a la terapia de base para la HAP en participantes adultos con HAP.
    E.2.2Secondary objectives of the trial
    The secondary objective is to follow participants from parent sotatercept studies that were treated with sotatercept or placebo and assess continued efficacy.
    El objetivo secundario consiste en hacer un seguimiento de los participantes procedentes de los estudios originales de sotatercept, tratados con sotatercept o placebo, y evaluar la continuación de la eficacia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible participants must meet the following criteria to be enrolled in the study:
    1. Participants must have completed their current respective PAH sotatercept clinical study, must have completed the parent study requirements, and must not have discontinued early.
    2. Participants must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements.
    3. Participants must have the ability to understand and provide written informed consent f.
    4. Females of childbearing potential must:
    a. Have a negative pregnancy tests as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug.
    b. If sexually active, have used, and agree to continue to use highly effective contraception without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug.
    c. Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug.
    5. Male participants must:
    a. Agree to use a condom, defined as a male latex condom or non-latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
    b. Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug.
    6. Participants must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the A011-12 study
    Para poder participar en el estudio, los pacientes deberán cumplir los siguientes criterios:
    1.Los participantes deberán haber completado su respectivo estudio clínico actual de sotatercept para la HAP y haber cumplido sus requisitos, y no podrán haberse retirado prematuramente.
    2.Los participantes deben estar dispuestos a cumplir el calendario de visitas del estudio y comprender y cumplir todos los requisitos del protocolo.
    3.Los participantes deben ser capaces de comprender y otorgar su consentimiento informado por escrito.
    4.Las mujeres con capacidad reproductiva deberán:
    a. Tener una prueba de embarazo negativa, verificada por el investigador antes de iniciar la administración del fármaco del estudio; deberá comprometerse a someterse a pruebas de embarazo periódicamente durante el estudio y hasta 8 semanas después de la última dosis del fármaco del estudio.
    b. En caso de ser sexualmente activas, haber utilizado y comprometerse a continuar utilizando un método anticonceptivo muy eficaz sin interrupción durante un mínimo de 28 días antes de empezar a recibir el producto en investigación, durante el estudio (incluidas las interrupciones de la administración) y durante 16 semanas (112 días) después de suspender el fármaco del estudio.
    c. Abstenerse de amamantar a un niño o de donar sangre u óvulos durante el estudio y durante al menos 16 semanas (112 días) después de la última dosis del fármaco del estudio.
    5. Los participantes varones deberán:
    a. Comprometerse a utilizar un preservativo, definido como un preservativo masculino de látex o de otro material diferente al látex que NO esté fabricado con membranas naturales (de origen animal), por ejemplo, de poliuretano, cuando mantengan relaciones sexuales con mujeres embarazadas o con capacidad para procrear mientras participen en el estudio, durante las interrupciones del tratamiento y hasta un mínimo de 16 semanas (112 días) después de la suspensión del producto en investigación, aunque se hayan sometido a una vasectomía con éxito.
    b. Abstenerse de donar sangre o semen durante el estudio y hasta 16 semanas (112 días) después de la última dosis del fármaco del estudio.
    6. Los participantes deberán comprometerse a no participar en ningún otro ensayo de fármacos o productos en investigación mientras participen en el estudio A011-12.
    E.4Principal exclusion criteria
    Participants will be excluded from the study if any of the following criteria are met:
    1. Not enrolled in a PAH parent study at the time of enrollment.
    2. Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
    3. Presence of an ongoing serious adverse event (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept.
    4. Pregnant or breastfeeding females.
    Se excluirá del estudio a los participantes que cumplan alguno de los criterios siguientes:
    1. No incluido en un estudio original sobre la HAP en el momento de la inclusión.
    2. Pérdida de más del equivalente a 4 dosis consecutivas entre el final del estudio original y el comienzo de este estudio.
    3. Presencia de un acontecimiento adverso grave persistente que se produzca durante un estudio clínico de sotatercept para la HAP y que se considere posible o probablemente relacionado con sotatercept.
    4. Embarazo o lactancia materna.
    E.5 End points
    E.5.1Primary end point(s)
    The following endpoints will be evaluated as a measure of safety and tolerability:
    • AEs
    • Anti-drug antibodies (ADA)
    • Clinical laboratory assessments (hematology and serum
    chemistry)
    • Vital signs
    • 12-lead electrocardiogram (ECG)
    Se evaluarán los siguientes criterios de valoración como medida de la seguridad y la tolerabilidad:
    - AAs
    - Anticuerpos contra el fármaco (ACF)
    - Evaluaciones analíticas (hematología y bioquímica en suero)
    - Constantes vitales
    - Electrocardiograma (ECG) de 12 derivaciones
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months and 48 months
    24 meses y 48 meses
    E.5.2Secondary end point(s)
    The following efficacy endpoints will be evaluated:
    • 6-minute walk distance
    • N-terminal pro-hormone B-type natriuretic peptide
    • World Health Organization functional class
    • Pulmonary vascular resistance
    • Overall survival
    Se evaluarán los siguientes criterios de valoración de la eficacia:
    - Distancia recorrida en 6 minutos
    - Propéptido natriurético de tipo B aminoterminal
    - Categoría funcional de la Organización Mundial de la Salud
    - Resistencia vascular pulmonar
    - Supervivencia general
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months and 48 months
    24 meses y 48 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 Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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
    Israel
    Korea, Republic of
    Mexico
    New Zealand
    Serbia
    United States
    Austria
    Belgium
    France
    Germany
    Ireland
    Italy
    Netherlands
    Poland
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    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
    A participant is considered to have completed the study if he/she has completed all phases of the study, including the EOT Visit and Follow-up Visit.
    The End of Study is defined as when the last participant completes the last visit.
    Se considera que un participante ha completado el estudio si él/ella ha completado todas las fases del mismo, incluyendo la Visita FdT y la visita de seguimiento.
    El final del estudio se define cuando el último participante completa la última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 326
    F.4.2.2In the whole clinical trial 700
    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
    Ninguno
    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 Decision2021-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-26
    P. End of Trial
    P.End of Trial StatusOngoing
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