Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-004033-20
    Sponsor's Protocol Code Number:ARGX-113-2005
    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:2021-06-09
    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 number2020-004033-20
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
    Ensayo en fase III, multicéntrico, sin enmascaramiento y a largo plazo para evaluar la seguridad y la eficacia de efgartigimod (ARGX-113) PH20 subcutáneo en pacientes adultos con trombocitopenia inmunitaria primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
    Estudio para evaluar la seguridad y la eficacia de efgartigimod (ARGX-113) PH20 subcutáneo en pacientes adultos con trombocitopenia inmunitaria primaria
    A.3.2Name or abbreviated title of the trial where available
    ADVANCE SC+
    ADVANCE SC+
    A.4.1Sponsor's protocol code numberARGX-113-2005
    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 Sponsorargenx BV
    B.1.3.4CountryBelgium
    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 supportargenx BV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationargenx BV
    B.5.2Functional name of contact pointRegulatory
    B.5.3 Address:
    B.5.3.1Street AddressIndustriepark Zwijnaarde 7
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post codeB-9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 9 310 3400
    B.5.6E-mailregulatory@argenx.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/3/19/2230
    D.3 Description of the IMP
    D.3.1Product nameefgartigimod PH20 SC
    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 INNefgartigimod alfa
    D.3.9.1CAS number 1821402-21-4
    D.3.9.2Current sponsor codeARGX-113
    D.3.9.4EV Substance CodeSUB198780
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 Yes
    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
    Primary immune thrombocytopenia (ITP)
    Trombocitopenia inmunitaria
    primaria (ITP)
    E.1.1.1Medical condition in easily understood language
    Disorder that can lead to easy or excessive bruising and bleeding due to low levels of the cells that help blood clot
    Trastorno que puede causar facilidad para sufrir hematomas y hemorragias o una cantidad excesiva debido a una baja concentración de las células que contribuyen a la coagulación de la sangre
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10083843
    E.1.2Term Primary immune thrombocytopenia
    E.1.2System Organ Class 100000004851
    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 safety and tolerability of efgartigimod PH20 SC in adult patients with primary ITP
    Evaluar la seguridad y la tolerabilidad de efgartigimod PH20 s.c. en pacientes adultos con TPI primaria
    E.2.2Secondary objectives of the trial
    First 52-week treatment period only
    • To evaluate the efficacy of efgartigimod PH20 SC on overall platelet count response
    • To evaluate the use of rescue treatment and reduction in concurrent ITP therapy while receiving treatment with efgartigimod PH20 SC
    • To evaluate the incidence and severity of bleeding events while receiving treatment with efgartigimod PH20 SC
    • To assess the PK of efgartigimod PH20 SC
    • To evaluate the effects of efgartigimod PH20 SC treatment on quality-of-life (QoL) measures and patient-reported outcomes (PRO)
    • To assess the PD effects of efgartigimod PH20 SC
    • To evaluate the feasibility of self-administration of efgartigimod PH20 SC

    First 52-week treatment period and additional 52-week treatment periods
    • To assess the immunogenicity of efgartigimod and/or rHuPH20
    Solo el primer periodo de tratamiento de 52 semanas
    • Evaluar la eficacia de efgartigimod PH20 s.c. en la respuesta global del número de plaquetas
    • Evaluar el uso del tratamiento de rescate y la disminución del tratamiento simultáneo de la TPI mientras se recibe el tratamiento con efgartigimod PH20 s.c.
    • Evaluar la incidencia y la gravedad de los acontecimientos hemorrágicos mientras se recibe el tratamiento con efgartigimod PH20 s.c.
    • Evaluar la FC de efgartigimod PH20 s.c.
    • Evaluar los efectos del tratamiento con efgartigimod PH20 s.c. en los parámetros de la calidad de vida (CdV) y los resultados percibidos por el paciente (RPP)
    • Evaluar los efectos de la FD de efgartigimod PH20 s.c.
    • Evaluar la viabilidad de la autoadministración de efgartigimod PH20 s.c.
    Primer periodo de tratamiento de 52 semanas y periodos de tratamiento adicionales de 52 semanas
    • Evaluar la inmunogenia de efgartigimod y/o rHuPH20
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the trial only if all of the following criteria apply:
    1. Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required trial visits).
    2. Participants enrolled in the ARGX-113-2004 trial who completed the 24-week trial period. Note: If a participant has had an SAE during the ARGX-113-2004 trial, his/her eligibility should be evaluated by the investigator and the sponsor’s trial physician. The decision of enrolling the participant will be evaluated case by case.
    3. Women of childbearing potential:
    • As defined in Woman of Childbearing Potential in the protocol, women of childbearing potential must have a negative urine pregnancy test at baseline before trial medication can be administered
    • Must be on a stable regimen for at least 1 month of a highly effective or acceptable method of contraception (see Female Contraception in the protocol) during the trial and for 90 days after the last administration of efgartigimod PH20 SC
    4. Non-sterilized male participants who are sexually active with a female partner of childbearing potential must use an acceptable method of contraception, ie, a condom (see Male Contraception in the protocol) from signing the informed consent form (ICF) until the end of the trial. Male participants are not allowed to donate sperm from signing the ICF until the end of the trial.
    In addition to the above criteria, for participants who want to continue receiving efgartigimod during an additional 52-week treatment period (only applicable in case efgartigimod is not yet commercially available for patients with primary ITP or available through another patient program for patients with primary ITP):
    5. Ability to understand the requirements of the additional 52-week treatment period of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).
    6. Participant has completed a 52-week treatment period.
    Los pacientes se considerarán idóneos para participar en el ensayo únicamente si cumplen todos los criterios que se detallan a continuación:
    1. Capacidad para comprender los requisitos del ensayo y proporcionar el consentimiento informado por escrito (incluido el consentimiento para el uso y la divulgación de información médica asociada con la investigación), estar dispuesto y ser capaz de seguir los procedimientos del protocolo del ensayo (incluida la asistencia a las visitas del ensayo requeridas).
    2. Participantes incluidos en el ensayo ARGX-113-2004 que han completado el periodo del ensayo de 24 semanas. Nota: Si un participante ha sufrido un AAG durante el ensayo ARGX-113-2004, el investigador y el médico del ensayo del promotor evaluarán su idoneidad. La decisión de incluir al participante se tomará de manera individual en cada caso.
    3. Mujeres en edad fértil:
    • Tal como se define en «Mujeres en edad fértil» del protocolo, estas mujeres deben dar negativo en la prueba de embarazo en orina en el momento basal antes de que se les pueda administrar el fármaco del ensayo
    • Deben seguir una pauta estable durante al menos 1 mes de un método anticonceptivo muy eficaz o aceptable (consulte «Métodos anticonceptivos femeninos muy eficaces» en el protocolo) durante el ensayo y durante 90 días posteriores a la última administración de efgartigimod PH20 s.c.
    4. Los varones no esterilizados que participen en el estudio y sean sexualmente activos, cuya pareja femenina esté en edad fértil, deben utilizar un método anticonceptivo aceptable, por ejemplo, un preservativo (consulte «Anticonceptivos masculinos» en el protocolo) desde el momento en que firmen el formulario de consentimiento informado (FCI) hasta el final del ensayo. Los varones participantes no pueden donar esperma desde la firma del FCI hasta el final del ensayo.
    Además de los criterios anteriores, en el caso de los participantes que deseen seguir recibiendo efgartigimod durante un periodo de tratamiento adicional de 52 semanas (solo aplicable en caso de que el efgartigimod todavía no esté comercialmente disponible para los pacientes con TPI primaria o esté disponible a través de otro programa para pacientes destinado a pacientes con TPI primaria):
    5. Capacidad para comprender los requisitos del periodo de tratamiento adicional de 52 semanas del ensayo, proporcionar el consentimiento informado por escrito (incluido el consentimiento para el uso y la divulgación de información médica asociada con la investigación) y cumplir con los procedimientos del protocolo del ensayo (incluidas las visitas del ensayo requeridas).
    6. Haber completado un periodo de tratamiento de 52 semanas.
    E.4Principal exclusion criteria
    Participants are eligible to be included in the trial only if none of the following criteria apply:
    1. Introduction or continuation of nonpermitted medications during the ARGX-113-2004 trial (such as anti-CD20 therapy, romiplostim, monoclonal antibodies, Fc fusion proteins, or live/live-attenuated vaccines)
    2. Use of any other investigational drug or participation in any other investigational trial
    3. Known hypersensitivity reaction to efgartigimod PH20 SC or any of its excipients
    4. Pregnant or lactating females and those who intend to become pregnant during the trial or within 90 days after last dose of efgartigimod PH20 SC
    Los pacientes se considerarán idóneos para participar en el ensayo únicamente si no cumplen ninguno de los criterios que se detallan a continuación:
    1. La introducción o la continuación de medicamentos que no estén permitidos durante el ensayo ARGX-113-2004 (como el tratamiento anti-CD20, romiplostim, anticuerpos monoclonales, proteínas de fusión Fc o vacunas con microbios vivos o atenuadas)
    2. El uso de cualquier otro fármaco en investigación o participación en algún otro ensayo de investigación
    3. Reacción de hipersensibilidad conocida al efgartigimod PH20 s.c. o a cualquiera de sus excipientes
    4. Mujeres gestantes o en período de lactancia y aquellas que piensan quedarse embarazadas durante el ensayo o durante los 90 días siguientes a la última dosis de efgartigimod PH20 s.c.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs)
    2. Vital signs, electrocardiogram (ECG), and laboratory safety evaluations
    Incidencia, frecuencia e intensidad de los acontecimientos adversos (AA), los AA de especial interés (AAEI) y los AA graves (AAG)
    2. Evaluaciones de las constantes vitales, el electrocardiograma (ECG) y las pruebas analíticas de seguridad
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At all visits
    2. At planned visits per schedule of assessment
    1. En todas las visitas
    2. En visitas programadas de acuerdo con el calendario de evaluaciones
    E.5.2Secondary end point(s)
    First 52-week treatment period only
    1. Extent of disease control defined as the percentage of weeks in the trial with platelet counts of ≥50×10^9/L
    2. Proportion of patients with overall platelet count response defined as achieving a platelet count of ≥50×10^9/L on at least 4 occasions at any time during the 52-week treatment period
    3. Mean change from baseline in platelet count at each visit
    4. For patients rolling over from the ARGX-113-2004 trial with a platelet count of <30×10^9/L: time to response defined as the time to achieve 2 consecutive platelet counts of ≥50×10^9/L
    5. The percentage of weeks in the trial with platelet counts of ≥30×10^9/L and ≥20×10^9/L above baseline
    6. In patients with a baseline platelet count of <15×10^9/L in the current trial (ARGX-113-2005), the percentage of weeks in the trial with platelet counts of ≥30×10^9/L and ≥20×10^9/L above baseline
    7. In patients with the first exposure to efgartigimod PH20 SC, the proportion of patients who achieve a sustained platelet response defined as achieving platelet counts of ≥50×10^9/L for at least 4 of the 6 visits between week 19 and week 24
    8. In patients with the first exposure to efgartigimod PH20 SC, the proportion of patients achieving platelet counts of ≥50×10^9/L for at least 6 of the 8 visits between week 17 and week 24
    9. Proportion of patients for whom dose and/or frequency of concurrent ITP therapies have been reduced compared to baseline
    10. Rate of receipt of rescue therapy (rescue per patient per month)
    11. Incidence and severity of the World Health Organization (WHO)-classified bleeding events
    12. Serum efgartigimod concentration observed predose (Ctrough)
    13. Change from baseline in PRO (Functional Assessment of Chronic Illness Therapy Fatigue Scale [FACIT-fatigue], Functional Assessment of Cancer Therapy questionnaire-Th6 [FACT-Th6]) and QoL (Short Form-36 [SF-36]) at planned visits
    14. Pharmacodynamics markers: total IgG
    15. Number and percentage of patients who performed self-administration at home over time
    16. Number and percentage of caregivers who administered the injection to the patient at home over time
    17. Number of training visits needed for the participant or caregiver to be competent to start administering efgartigimod PH20 SC
    18. Number and percentage of self- or caregiver-supported administrations at home

    First 52-week treatment period and additional 52-week treatment periods
    19. Incidence and prevalence of antibodies to efgartigimod
    20. Titers of antibodies to efgartigimod
    21 Presence of neutralizing antibodies (NAb) against efgartigimod
    Solo el primer periodo de tratamiento de 52 semanas

    1. Alcance del control de la enfermedad, que se define como el porcentaje de semanas durante el ensayo con un número de plaquetas ≥50 × 109/l
    2. Proporción de pacientes con una respuesta global del número de plaquetas, que se define como alcanzar un número de plaquetas ≥50 × 109/l en al menos 4 ocasiones en cualquier momento durante el periodo de tratamiento de 52 semanas
    3. Media del cambio en el número de plaquetas desde el momento basal en cualquier visita
    4. En el caso de los pacientes procedentes del ensayo ARGX-113-2004 con un número de plaquetas <30 × 109/l, el tiempo de respuesta, que se define como alcanzar dos números de plaquetas consecutivos ≥50 × 109/l
    5. El porcentaje de semanas durante el ensayo con un número de plaquetas ≥30 × 109/l y ≥20 × 109/l por encima del valor basal
    6. En el caso de pacientes con un número basal de plaquetas <15 × 109/l en el ensayo actual (ARGX-113-2005), el porcentaje de semanas durante el ensayo con un número de plaquetas ≥30 × 109/l y ≥20 × 109/l por encima del valor basal
    7. En el caso de pacientes que se exponen por primera vez a efgartigimod PH20 s.c., la proporción de pacientes que consiguen mantener la respuesta de plaquetas, que se define como alcanzar un número de plaquetas ≥50 × 109/l durante al menos 4 de las 6 visitas entre la semana 19 y la semana 24
    8. En el caso de pacientes que se exponen por primera vez a efgartigimod PH20 s.c., la proporción de pacientes que consiguen un número de plaquetas ≥50 × 109/l durante al menos 6 de las 8 visitas entre la semana 17 y la semana 24
    9. Proporción de pacientes para los que se ha disminuido la dosis o la frecuencia de los tratamientos simultáneos para la TPI en comparación con el momento basal
    10. Tasa de administración de tratamiento de rescate (rescate por paciente por mes)
    11. Incidencia y gravedad de los acontecimientos hemorrágicos según la clasificación de la Organización Mundial de la Salud (OMS)
    12. La concentración sérica de efgartigimod observada antes de la dosis (Cmín)
    13. Cambio en los RPP desde el momento basal (la escala de evaluación funcional de terapia de enfermedades crónicas para el cansancio [FACIT-fatiga], el cuestionario de evaluación funcional de la terapia antineoplásica Th6 [Fact-Th6]) y la CdV (formulario abreviado-36 [SF-36]) en las visitas programadas
    14. Marcadores farmacodinámicos: IgG total
    15. Número y porcentaje de pacientes que se autoadministran en el domicilio a lo largo del tiempo
    16. Número y porcentaje de cuidadores que administran la inyección al paciente en el domicilio a lo largo del tiempo
    17. Número de visitas de formación necesarias para que el participante o el cuidador adquirieran la suficiente competencia para comenzar a administrar efgartigimod PH20 s.c.
    18. Número y porcentaje de administraciones realizadas en el domicilio por el paciente o con ayuda del cuidador

    Primer periodo de tratamiento de 52 semanas y periodos de tratamiento adicionales de 52 semanas
    19. Incidencia y prevalencia de los anticuerpos frente a efgartigimod
    20. Valores de los anticuerpos frente a efgartigimod
    21 Presencia de anticuerpos neutralizantes (AcN) frente a efgartigimod
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2 At any time during the 52-week treatment period
    3. At each visit
    4, 5, 6 At planned visits per schedule of assessment
    7. Between week 19 and week 24
    8. Between week 17 and week 24
    9,10,11,12, 13, 14 At planned visits per schedule of assessment
    15, 16, 17, 18 Throughout the treatment period
    19, 20, 21 At planned visits per schedule of assessments
    1, 2 En cualquier momento durante el periodo de tratamiento de 52 semanas
    3. En cada visita
    4, 5, 6 En visitas programadas de acuerdo con el calendario de evaluaciones
    7. Entre la semana 19 y la semana 24
    8. Entre la semana 17 y la semana 24
    9, 10, 11, 12, 13, 14 En visitas programadas de acuerdo con el calendario de evaluaciones
    15, 16, 17, 18 Durante todo el periodo de tratamiento
    19, 20, 21 En visitas programadas de acuerdo con el calendario de evaluaciones
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Chile
    China
    Colombia
    Georgia
    Israel
    Japan
    Jordan
    Korea, Republic of
    Mexico
    New Zealand
    Peru
    Russian Federation
    Serbia
    South Africa
    Taiwan
    Thailand
    Tunisia
    Turkey
    United States
    Bulgaria
    Denmark
    France
    Germany
    Greece
    Ireland
    Italy
    Latvia
    Norway
    Poland
    Portugal
    Romania
    Spain
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 136
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    F.4.2.2In the whole clinical trial 156
    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 a participant has completed the trial, has withdrawn/discontinued early, or has completed the 2 follow-up visits, usual treatment will be administered if required, in accordance with the trial site’s standard of care and generally accepted medical practice depending on the participant’s individual needs.
    Cuando un participante haya finalizado el ensayo, haya abandonado o se haya retirado anticipadamente o haya completado las 2 visitas de seguimiento, se le administrará el tratamiento habitual si es necesario, de conformidad con las normas asistenciales del centro y la práctica médica generalmente aceptada, en función de las necesidades concretas de dicho participante.
    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 Decision2021-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-28
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA