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    Summary
    EudraCT Number:2017-003114-10
    Sponsor's Protocol Code Number:NI-0501-09
    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:2018-02-16
    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 number2017-003114-10
    A.3Full title of the trial
    An Open-label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNγ) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis
    Un estudio abierto, de brazo único, multicéntrico, para ampliar el acceso a emapalumab, un anticuerpo monoclonal anti-interferón gamma (anti-IFNγ), y para evaluar su eficacia, seguridad, impacto en la calidad de vida y resultados a largo plazo en pacientes de pediatría con linfohistiocitosis hemofagocítica primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study conducted in several Countries, to give access to emapalumab, and to study how efficacious and safe is in children with primary Hemophagocytic Lymphohistiocytosis (pHLH)
    Estudio realizado en varios países para dar acceso a emapalumab y estudiar la eficacia y seguridad en en niños con linfohistiocitosis hemofagocítica primaria (pHLH)
    A.4.1Sponsor's protocol code numberNI-0501-09
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01818492
    A.5.4Other Identifiers
    Name:US IND numberNumber:111015
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/358/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovimmune S.A.
    B.1.3.4CountrySwitzerland
    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 supportNovimmune S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovimmune SA
    B.5.2Functional name of contact pointIsabelle Fournet
    B.5.3 Address:
    B.5.3.1Street Address14 Chemin des Aulx
    B.5.3.2Town/ cityPlan-les-Ouates
    B.5.3.3Post code1228
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4122 593 51 58
    B.5.5Fax number+4122 5938280
    B.5.6E-mailNI-0501.clinops@novimmune.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/3/10/749
    D.3 Description of the IMP
    D.3.1Product nameEmapalumab
    D.3.2Product code NI-0501
    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 INNEMAPALUMAB
    D.3.9.2Current sponsor codeNI-0501
    D.3.9.3Other descriptive nameFully human anti-interferon gamma monoclonal antibody
    D.3.9.4EV Substance CodeSUB188645
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Hemophagocytic Lymphohistiocytosis (pHLH)
    Linfohistiocitosis hemofagocítica primaria (LHHp)
    E.1.1.1Medical condition in easily understood language
    A rare, life-threatening condition affecting predominantly children. The disease is characterized by uncontrolled inflammation.
    Una enfermedad rara que afecta predominantemente a niños y que pone en peligro la vida. La enfermedad se caracteriza por una inflamación no controlada.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071583
    E.1.2Term Haemophagocytic lymphohistiocytosis
    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 gather additional safety and efficacy data on emapalumab in pHLH patients.
    •Obtener datos de seguridad y eficacia adicionales sobre el emapalumab en pacientes con LHHp
    E.2.2Secondary objectives of the trial
    • To assess a starting dose of emapalumab of 3 mg/kg.
    • To assess the impact of emapalumab on Quality of Life (QOL).
    • To gather additional evidence on the long-term outcome of pHLH patients treated with emapalumab.
    • To further evaluate the pharmacokinetic (PK) profile of emapalumab in pHLH patients.
    • To further evaluate the pharmacodynamic (PD) effects (levels of circulating Total IFNγ and biomarkers of its neutralization, namely CXCL9 and CXCL10).
    • To assess the profile of other relevant HLH biomarkers, e.g., sCD25 and other exploratory biomarkers.
    •To monitor for potential occurrence of anti-drug antibodies (ADAs).
    •Evaluar una dosis inicial de emapalumab de 3 mg/kg
    •Evaluar el impacto del emapalumab en la calidad de vida (CdV)
    •Recopilar datos adicionales sobre el resultado a largo plazo de los pacientes con LHHp tratados con emapalumab
    •Evaluar el perfil farmacocinético (FC) del emapalumab en pacientes con LHHp
    •Evaluar los efectos farmacodinámicos (FD) (niveles de IFNγ total circulante y biomarcadores de su neutralización, concretamente CXCL9 y CXCL10)
    •Evaluar el perfil de otros biomarcadores relevantes de la LHH, p. ej. sCD25 y otros biomarcadores exploratorios
    •Controlar la posible aparición de anticuerpos contra el fármaco (ADA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female pHLH patients, from birth up to and including 18 years at diagnosis of HLH.
    2. A molecular diagnosis or familial history consistent with pHLH or fulfilment of HLH-2004 diagnostic criteria, i.e., five of the eight criteria below:
    - Fever
    - Splenomegaly
    - Cytopenias affecting 2 of 3 lineages in the peripheral blood (hemoglobin <90 g/L; platelets <100 x 109/L; neutrophils <1 x 109/L)
    - Hypertriglyceridemia (fasting triglycerides ≥3 mmol/L or ≥265 mg/dL) and/or hypofibrinogenemia (≤1.5 g/L)
    - Hemophagocytosis in bone marrow, spleen or lymph nodes, with no evidence of malignancy
    - Low or absent natural killer (NK)-cell activity
    - Ferritin ≥500 µg/L
    - Soluble CD25 (sCD25, i.e., soluble IL-2 receptor) ≥2400 U/mL.
    3. Presence of active HLH disease as assessed by the treating physician.
    4. Patients having already received HLH conventional therapy must fulfil one of the following criteria as assessed by the treating physician:
    - Having not responded
    - Having not achieved a satisfactory response
    - Having reactivated
    - Showing intolerance to previous conventional treatment of HLH.
    5. Informed consent signed by the patient (as required by local law), or by the patient’s legally authorized representative(s) with the assent of patients who are legally capable of providing it, as applicable.
    6. Having received guidance on contraception for both male and female patients sexually active and having reached puberty.
    Females of child-bearing potential require use of highly effective contraceptive measures (failure rate of less than 1% per year) from Screening until 6 months after receiving last dose of the study drug.
    Males with partner(s) of child-bearing potential must agree to take appropriate precautions (such as sexual abstinence, barrier contraception, vasectomy) to avoid fathering a child from Screening until 6 months after receiving last dose of study drug.
    1.Pacientes con LHHp de ambos sexos, desde el nacimiento hasta e incluyendo los 18 años de edad en el momento del diagnóstico de LHH.
    2.Diagnóstico molecular o antecedentes familiares compatibles con LHHp o cumplimiento de los criterios diagnósticos HLH-2004, es decir, cinco de los ocho criterios siguientes:
    -Fiebre
    -Esplenomegalia
    -Citopenias que afecten a 2 de las 3 líneas en sangre periférica (hemoglobina < 90 g/l; plaquetas < 100 x 109/l; neutrófilos < 1 x 109/l)
    -Hipertrigliceridemia (triglicéridos en ayunas ≥ 3 mmol/l o ≥ 265 mg/dl) y/o hipofibrinogenemia (≤ 1,5 g/l)
    -Hemofagocitosis en médula ósea, bazo o ganglios linfáticos, sin evidencia de neoplasia maligna
    -Actividad de los linfocitos citolíticos naturales (NK) baja o nula
    -Ferritina ≥ 500 µg/l
    -CD25 soluble (sCD25, es decir, receptor soluble de la IL-2) ≥ 2400 U/ml
    3.Presencia de enfermedad por LHH activa según el criterio del médico responsable del tratamiento.
    4.Los pacientes que ya hayan recibido tratamiento convencional para la LHH deben cumplir uno de los criterios siguientes según la valoración del médico responsable del tratamiento:
    -No haber mostrado ninguna respuesta
    -No haber obtenido una respuesta satisfactoria o haber empeorado
    -Haber presentado reactivación
    -Haber presentado intolerancia al tratamiento convencional previo de la LHH
    En el momento de la inclusión en el estudio, los pacientes elegibles pueden estar todavía recibiendo tratamiento (inducción o mantenimiento) o pueden haberlo interrumpido.
    5.Consentimiento informado firmado por el paciente (conforme a la normativa local), o por los representantes legalmente autorizados del paciente con el asentimiento de los pacientes que estén legalmente capacitados para proporcionarlo, según proceda.
    6.Haberse facilitado asesoramiento sobre medidas anticonceptivas a pacientes de ambos sexos sexualmente activos y que hayan alcanzado la pubertad.
    Las mujeres con capacidad de procrear deben utilizar métodos anticonceptivos muy eficaces (con una tasa de fracaso anual inferior al 1 %) desde la selección hasta 6 meses después de recibir la última dosis del fármaco del estudio.
    Los métodos anticonceptivos muy eficaces incluyen:
    oAbstinencia sexual
    oAnticonceptivos hormonales: combinación o progesterona solamente
    oMétodos intrauterinos: dispositivos o sistemas intrauterinos
    oOclusión de trompas bilateral
    oCompañero sexual sometido a vasectomía
    Los hombres con pareja(s) con capacidad de procrear deben adoptar precauciones apropiadas (como abstinencia sexual, uso de anticonceptivos de barrera, vasectomía) para no engendrar un hijo desde la selección hasta los 6 meses posteriores a la administración de la última dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    1. Diagnosis of secondary HLH consequent to a proven rheumatic, metabolic or neoplastic disease.
    2. Active mycobacteria, Histoplasma Capsulatum, Shigella, Salmonella, Campylobacter or Leishmania infections.
    3. Evidence of latent tuberculosis.
    4. Presence of malignancy.
    5. Patients who have another concomitant disease or malformation severely affecting cardiovascular, pulmonary, central nervous system (CNS), liver, or renal function that in the opinion of the Investigator may significantly affect the likelihood to respond to treatment and/or the assessment of emapalumab safety and/or efficacy.
    6. History of hypersensitivity or allergy to any component of the study regimen (e.g., polysorbate).
    7. Receipt of a bacille Calmette-Guerin (BCG) vaccine within 12 weeks prior to Screening.
    8. Receipt of a live or attenuated live (other than BCG) vaccine within 6 weeks prior to Screening.
    9. Pregnant or lactating female patients.
    1.Diagnóstico de LHH secundaria debida a una enfermedad reumática, metabólica o neoplásica confirmada.
    2.Infecciones activas por micobacterias, Histoplasma Capsulatum, Shigella, Salmonella, Campylobacter o Leishmania .
    3.Evidencia de tuberculosis latente.
    4.Presencia de neoplasia maligna.
    5.Pacientes que tienen otra malformación o enfermedad concomitante que afecta gravemente a la función cardiovascular, pulmonar, del sistema nervioso central (SNC), hepática o renal que, en opinión del investigador, podría afectar significativamente a la probabilidad de responder al tratamiento y/o a la evaluación de la seguridad y/o la eficacia del emapalumab.
    6.Antecedentes de hipersensibilidad o alergia a cualquiera de los componentes de la pauta del estudio (p. ej., polisorbato).
    7.Administración de una vacuna de bacilo de Calmette y Guérin (BCG) en las 12 semanas anteriores a la selección.
    8.Administración de una vacuna viva o viva atenuada (distinta de la vacuna BCG) en las 6 semanas anteriores a la selección.
    9.Pacientes embarazadas o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    • Overall Response, i.e., achievement of either Complete or Partial Response or HLH Improvement, at End of Treatment (EOT) or Week 8 (whichever occurs earlier).
    Criterio principal de valoración de la eficacia:
    • Respuesta global, es decir, consecución de respuesta completa o parcial o mejoría de la LHH, al final del tratamiento (FdT) o la semana 8 (lo que ocurra primero)
    E.5.1.1Timepoint(s) of evaluation of this end point
    See E.5.1
    Ver E.5.1
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • Overall Survival, including survival to HSCT and survival after either HSCT or last emapalumab infusion (if HSCT is not performed)
    • Event-free Survival
    • Overall Response, i.e., achievement of either Complete or Partial Response or HLH Improvement, at start of conditioning (or at last emapalumab infusion if HSCT is not performed)
    • Duration of Response, ie, maintenance of response achieved any time during the study (with censoring time at start of conditioning for patients with no events)
    • Time to Response at any time during the study
    • Number of patients able to reduce glucocorticoids by 50% or more of baseline dose at any time during emapalumab treatment
    • Number of patients able to proceed to HSCT, when deemed indicated
    • Quality of Life (QOL) indices.

    Safety endpoints:
    • Incidence, severity, causality and outcomes of AEs (serious and non-serious).
    • Evolutions of relevant laboratory parameters, e.g., complete blood cell (CBC) count, liver and renal function tests, and coagulation parameters.
    • Number of patients who discontinued emapalumab treatment for safety reasons.

    PK/PD Endpoints:
    • Serum concentrations of emapalumab to further evaluate emapalumab PK profile.
    • Determination of PD parameters (levels of circulating total IFNγ and markers of its neutralization, namely CXCL9 and CXCL10).
    • Determination of other relevant disease biomarkers, eg, sCD25 and other exploratory biomarkers.
    • Measurement of emapalumab concentrations and PD parameters in other matrices, eg, cerebrospinal fluid (CSF), bronchoalveolar lavage fluid (BALF), if clinically appropriate (exploratory).
    • Level (if any) of circulating antibodies against emapalumab (ADAs).
    Criterios secundarios de valoración de la eficacia:
    • Supervivencia global, incluyendo supervivencia hasta el TCMH y supervivencia después del TCMH o la última infusión de emapalumab (si no se realiza un TCMH)
    • Supervivencia sin acontecimientos
    • Respuesta global, es decir, consecución de respuesta completa o parcial o mejoría de la LHH, al principio del acondicionamiento (o durante la última infusión de emapalumab si no se realiza un TCMH)
    • Duración de la respuesta, es decir, mantenimiento de la respuesta alcanzada en cualquier momento del estudio (con un periodo con datos incompletos en el momento de iniciar el acondicionamiento en pacientes sin acontecimientos)
    • Tiempo hasta la respuesta en cualquier momento durante el estudio
    • Número de pacientes en quienes pueden reducirse los glucocorticoides en un 50 % o más respecto a la dosis inicial en cualquier momento durante el tratamiento con emapalumab
    • Número de pacientes que se considera que pueden proceder a un TCMH, cuando se considera indicado
    • Índices de calidad de vida (CdV)
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2.
    Ver E.5.2
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    France
    Germany
    Italy
    Spain
    Sweden
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    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 months5
    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 months5
    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: 33
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 2
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 18
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Newborns, infants and toddlers
    Recién nacidos, infantes y niños
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 34
    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)
    In case of HLH reactivation (eg transplant failure), the patient will be treated according to the standard of care of the site.
    En caso de reactivación de LHH (por ejemplo, fallo de trasplante) el paciente será tratado de acuerdo a la terapia habitual del centro.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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