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    Summary
    EudraCT Number:2020-003884-25
    Sponsor's Protocol Code Number:4202-HEM-301
    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 number2020-003884-25
    A.3Full title of the trial
    An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease
    Estudio multicéntrico, aleatorizado, controlado con placebo, doble ciego y adaptativo de FT-4202 oral, un activador de la piruvato cinasa en pacientes con anemia drepanocítica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study is a randomized, placebo-controlled, double-blind, multicenter Phase 2/3 study of patients, age 12 to 65 years, with sickle cell disease (SCD).
    Este es un estudio randomizado, controlado con placebo, doble ciego, multicéntrico de fase II/III con pacientes de edad de 12 a 65 años, con anemia drepanocítica
    A.4.1Sponsor's protocol code number4202-HEM-301
    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 SponsorForma Therapeutics, 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 supportForma Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationForma Therapeutics, Inc.
    B.5.2Functional name of contact pointFitzroy Dawkins, MD
    B.5.3 Address:
    B.5.3.1Street Address500 Arsenal Street, Suite 100
    B.5.3.2Town/ cityWatertown
    B.5.3.3Post codeMA 02742
    B.5.3.4CountryUnited States
    B.5.4Telephone number609751-7258
    B.5.6E-mail4202medicalmonitor@formatherapeutics.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 numberEMA-OD-0000033107
    D.3 Description of the IMP
    D.3.1Product nameFT-4202
    D.3.2Product code FT-4202
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFT-4202
    D.3.9.1CAS number FT-4202
    D.3.9.2Current sponsor codeFT-4202
    D.3.9.3Other descriptive name(S)-1-(5-((2,3-dihydro-[1,4]dioxino[2,3-b]pyridin-7-yl)sulfonyl)-3,4,5,6-tetrahydropyrrolo[3,4-c]pyrrol-2(1H)-yl)-3-hydroxy-2-phenylpropan-1-one
    D.3.9.4EV Substance CodeSUB207913
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.IMP: 2
    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 numberEMA-OD-0000033107
    D.3 Description of the IMP
    D.3.1Product nameFT-4202
    D.3.2Product code FT-4202
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFT-4202
    D.3.9.1CAS number FT-4202
    D.3.9.2Current sponsor codeFT-4202
    D.3.9.3Other descriptive name(S)-1-(5-((2,3-dihydro-[1,4]dioxino[2,3-b]pyridin-7-yl)sulfonyl)-3,4,5,6-tetrahydropyrrolo[3,4-c]pyrrol-2(1H)-yl)-3-hydroxy-2-phenylpropan-1-one
    D.3.9.4EV Substance CodeSUB207913
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    sickle cell disease (SCD)
    anemia drepanocítica (AD)
    E.1.1.1Medical condition in easily understood language
    sickle cell disease (SCD)
    anemia drepanocítica (AD)
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10040644
    E.1.2Term Sickle cell disease
    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 assess the efficacy of FT-4202 in adolescents and adults with SCD as compared to placebo as measured by improvement in hemoglobin (Hb)
    • To assess the efficacy of FT-4202 as compared to placebo on the annualized vaso-occlusive crisis (VOC) rate
    •Evaluar la eficacia de FT-4202 en adolescentes y adultos con AD en comparación con placebo medida por la mejora de la hemoglobina (Hb).
    •Evaluar la eficacia de FT-4202 en comparación con placebo en la tasa anualizada de crisis vasooclusivas (CVO).
    E.2.2Secondary objectives of the trial
    • To measure the effects of FT-4202 on clinical measures and sequelae of hemolysis
    • To evaluate the effects of FT-4202 on the sequelae of VOC
    • To assess changes in fatigue of sickle cell patients taking FT-4202
    •Medir los efectos de FT-4202 en las medidas clínicas y las secuelas de la hemólisis.
    •Evaluar los efectos de FT-4202 sobre las secuelas de las CVO.
    •Evaluar los cambios en la fatiga de los pacientes con anemia drepanocítica que toman FT-4202.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Provision of consent
    2) Patient has a confirmed diagnosis of sickle cell disease
    3) At least 2 episodes of vaso-occlusive crises in the past 12 months
    4) Hemoglobin ≥ 5.5 and ≤ 10 g/dL (≥ 55 and ≤ 100 g/L) during screening
    5) Patients taking hydroxyurea, must demonstrate a stable dose for at least 90 days prior to start of study treatment
    6) Female patients of childbearing potential must use highly effective methods of contraception, male patients are willing to use barrier methods of contraception
    1) Prestación de consentimiento
    2) El paciente tiene un diagnóstico confirmado de anemia de células falciformes.
    3) Al menos 2 episodios de crisis vasooclusivas en los últimos 12 meses
    4) Hemoglobina ≥ 5,5 y ≤ 10 g / dL (≥ 55 y ≤ 100 g / L) durante el cribado
    5) Los pacientes que toman hidroxiurea deben demostrar una dosis estable durante al menos 90 días antes del inicio del tratamiento del estudio.
    6) Las pacientes femeninas en edad fértil deben utilizar métodos anticonceptivos altamente eficaces, los pacientes masculinos están dispuestos a utilizar métodos anticonceptivos de barrera.
    E.4Principal exclusion criteria
    Medical Conditions
    1) More than 10 vaso-occlusive crises within the past 12 months
    2) Female who is breast feeding or pregnant
    3) Hepatic dysfunction characterized by:
    - Alanine aminotransferase (ALT) > 4.0 × upper limit of normal (ULN)
    - Direct bilirubin > 3.0 × ULN
    4) Known HIV positive
    5) Active hepatitis B or hepatitis C infection
    6) Severe renal dysfunction or on chronic dialysis
    7) History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent including but not limited to the following:
    - Unstable angina pectoris or myocardial infarction or elective coronary intervention
    - Congestive heart failure requiring hospitalization
    - Uncontrolled clinically significant arrhythmias
    - Symptomatic pulmonary hypertension
    8) History of overt clinical stroke within previous 2 years or any history of an intracranial hemorrhage
    Prior/Concomitant Therapy
    1) Patients receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion)
    2) Receiving or use of concomitant medications that are strong inducers or moderate/strong inhibitors of CYP3A4/5 within 2 weeks of starting study treatment or anticipated need for such agents during the study
    3) Use of voxelotor within 28 days prior to starting study treatment or anticipated need for this agent during the study
    4) Use of a selectin antagonist (eg, crizanlizumab or other monoclonal antibody or small molecule) within 28 days of starting study treatment or anticipated need for such agents during the study
    5) Use of erythropoietin or other hematopoietic growth factor treatment within 28 days of starting study treatment or anticipated need for such agents during the study
    6) Receipt of prior cellular-based therapy (eg, hematopoietic cell transplant, gene modification therapy)
    Condiciones médicas
    1) Más de 10 crisis vasooclusivas en los últimos 12 meses
    2) Mujer que está amamantando o embarazada
    3) Disfunción hepática caracterizada por: - Alanina aminotransferasa (ALT)> 4.0 × límite superior de lo normal (LSN) - Bilirrubina directa> 3,0 × LSN
    4) VIH positivo conocido
    5) Infección activa por hepatitis B o hepatitis C
    6) Disfunción renal grave o en diálisis crónica
    7) Historial de enfermedad cardíaca o pulmonar inestable o en deterioro dentro de los 6 meses anteriores al consentimiento, incluidos, entre otros, los siguientes:
    - Angina de pecho inestable o infarto de miocardio o intervención coronaria elective
    - Insuficiencia cardíaca congestiva que requiere hospitalización.
    - Arritmias clínicamente significativas no controladas
    - Hipertensión pulmonar sintomática
    8) Historia de accidente cerebrovascular clínico manifiesto en los 2 años anteriores o cualquier historia de hemorragia intracraneal

    Terapia previa / concomitante
    1) Pacientes que reciben terapia de transfusión de sangre (RBC) programada regularmente (también denominada transfusión crónica, profiláctica o preventiva)
    2) Recibir o usar medicamentos concomitantes que sean inductores fuertes o inhibidores moderados / fuertes de CYP3A4 / 5 dentro de las 2 semanas posteriores al inicio del tratamiento del estudio o la necesidad anticipada de dichos agentes durante el estudio.
    3) Uso de voxelotor dentro de los 28 días anteriores al inicio del tratamiento del estudio o necesidad anticipada de este agente durante el estudio.
    4) Uso de un antagonista de selectina (p. Ej., Crizanlizumab u otro anticuerpo monoclonal o molécula pequeña) dentro de los 28 días posteriores al inicio del tratamiento del estudio o la necesidad anticipada de dichos agentes durante el estudio.
    5) Uso de eritropoyetina u otro tratamiento con factor de crecimiento hematopoyético dentro de los 28 días posteriores al inicio del tratamiento del estudio o la necesidad anticipada de dichos agentes durante el estudio.
    6) Recepción de terapia celular previa (p. Ej., Trasplante de células hematopoyéticas, terapia de modificación genética)
    E.5 End points
    E.5.1Primary end point(s)
    • Hb response rate at Week 24 (increase of > 1 g/dL [> 10 g/L] from baseline) during the blinded treatment period
    • Annualized VOC rate during the 52-week blinded treatment period based on adjudicated VOC review
    •Tasa de respuesta de la Hb en la semana 24 (aumento de >1 g/dl [>10 g/l] desde el inicio) durante el periodo de tratamiento enmascarado.
    •Tasa anualizada de CVO durante el periodo de tratamiento enmascarado de 52 semanas según la revisión de CVO adjudicada.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Hemoglobin response rate at Week 24 (increase of > 1 g/dL [> 10 g/L] from baseline) during the blinded treatment period [ Time Frame: 24 Weeks ]
    2. Annualized vaso-occlusive crisis rate during the 52-week blinded treatment period based on adjudicated vaso-occlusive crisis review [ Time Frame: 52 Weeks ]
    1. Tasa de respuesta de la hemoglobina en la semana 24 (aumento de> 1 g / dL [> 10 g / L] desde el valor inicial) durante el período de tratamiento ciego [intervalo de tiempo: 24 semanas]
    2. Tasa anualizada de crisis vasooclusiva durante el período de tratamiento ciego de 52 semanas según la revisión de crisis vasooclusiva adjudicada [intervalo de tiempo: 52 semanas]
    E.5.2Secondary end point(s)
    • Change from baseline in Hb at Week 24 during the blinded treatment period
    • Change in SCD-related clinical laboratory measurements from baseline at Week 24 during the blinded treatment period in:
    o % reticulocytes,
    o Unconjugated bilirubin, and
    o Lactate dehydrogenase (LDH)
    • Time to first VOC during the blinded treatment period
    • Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale at Week 24 during the blinded treatment period
    •Cambio con respecto al inicio en la Hb en la semana 24 durante el periodo de tratamiento enmascarado.
    •Cambio en las mediciones analíticas clínicas relacionadas con la AD con respecto al inicio en la semana 24 durante el periodo de tratamiento enmascarado en:
    o el porcentaje de reticulocitos,
    o la bilirrubina no conjugada y
    o la lactato deshidrogenasa (LDH).
    •Tiempo hasta la primera CVO durante el periodo de tratamiento enmascarado.
    •Cambio con respecto al inicio en la escala de fatiga del sistema de información de medición de resultados notificados por el paciente (PROMIS) en la semana 24 durante el periodo de tratamiento enmascarado.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Change from baseline in hemoglobin at W24 during the blinded treatment period [Time Frame: 24 Weeks]
    2. Change in SCD related clinical lab measurements from baseline at W24 during the blinded treatment period [Time Frame: 24 Weeks]
    - % reticulocytes; Unconjugated bilirubin; Lactate dehydrogenase
    3. Time to first vaso-occlusive during the blinded treatment period [Time Frame: 52 Weeks]
    4. Change from baseline in PROMIS) Fatigue Scale at W24 during the blinded treatment period [Time Frame: 24 Weeks]
    Adult patients (18 to 65) will complete the PROMIS® Item Bank v.1.0 - Fatigue - Short Form 7a. Adolescent patients (12 to 17) will complete the PROMIS® Item Bank v2.0 - Fatigue - Short Form 10a. Responses are graded on a score of 1 to 5 with a higher score indicating a worse outcome.
    1. Cambio desde el valor inicial en la hemoglobina en la S24 durante el período de tratamiento cegado
    2. Cambio en las mediciones de laboratorio clínico relacionadas con la SCD desde el inicio en la S24 durante el período de tratamiento ciego :% de reticulocitos;Bilirrubina no conjugada;Lactato deshidrogenasa
    3. Tiempo hasta la primera vasooclusión durante el período de tratamiento ciego
    4. Cambio desde el inicio en PROMIS) Escala de fatiga en S24 durante el período de tratamiento ciego
    Los pacientes adultos completarán el PROMIS® Item Bank v.1.0 - Fatiga - Short Form 7a.
    Los pacientes adolescentes completarán el PROMIS® Item Bank v2.0 - Fatiga - Short Form 10a.
    Las respuestas se califican con una puntuación de 1 a 5, y una puntuación más alta indica un resultado peor
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Canada
    United States
    France
    Germany
    Italy
    Spain
    United Kingdom
    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
    última visita del ultimo paciente
    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 months2
    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 months2
    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: 40
    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: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 302
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 94
    F.4.2.2In the whole clinical trial 344
    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)
    Once patients complete the Phase 2/3 blinded portions of the trial, an open-label extension is available for patients continuing to derive benefit as determined by their physician. Expanded access may be available until marketing approval or discontinuation of the development program.
    Una vez que los pacientes completan las partes ciegas de la Fase 2/3 del ensayo, se encuentra disponible una extensión abierta para que los pacientes continúen obteniendo beneficios según lo determine su médico. El acceso ampliado puede estar disponible hasta la aprobación de marketing o la interrupción del programa de desarrollo.
    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 Decision2021-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-26
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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