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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   33313   clinical trials with a EudraCT protocol, of which   5397   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).
     
    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:2018-000482-36
    Sponsor's Protocol Code Number:CL02-ORY-1001AML
    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:2018-06-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-000482-36
    A.3Full title of the trial
    A pilot study to assess the safety, tolerability, dose finding and efficacy of ORY-1001 in combination with azacitidine in older patients with AML in first line therapy.
    Estudio piloto para evaluar la seguridad, tolerabilidad, búsqueda de dosis y eficacia de ORY-1001 en combinación con azacitidina en pacientes mayores con Leucemia Mieloide Aguda (AML) en primera línea terapéutica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot study to assess the safety, tolerability, dose finding and efficacy of ORY-1001 in combination with azacitidine in older patients with AML in first line therapy.
    Estudio piloto para evaluar la seguridad, tolerabilidad, respuesta de dosis y eficacia de ORY-1001 en combinación con azacitidina en pacientes mayores con ALM en primera línea terapéutica.
    A.3.2Name or abbreviated title of the trial where available
    ALICE
    ALICE
    A.4.1Sponsor's protocol code numberCL02-ORY-1001AML
    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 SponsorOryzon Genomics S. A.
    B.1.3.4CountrySpain
    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 supportOryzon Genomics S. A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOryzon Genomics S. A.
    B.5.2Functional name of contact pointRoger Bullock
    B.5.3 Address:
    B.5.3.1Street AddressSant Ferran 74
    B.5.3.2Town/ cityCornellá de Llobregat
    B.5.3.3Post code08940
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 93 515 13 13
    B.5.5Fax number+34 93 377 40 28
    B.5.6E-mailrbullock@oryzon.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/3/13/1174
    D.3 Description of the IMP
    D.3.1Product nameORY-1001.2HCl
    D.3.2Product code PEI 13-106
    D.3.4Pharmaceutical form Oral solution
    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 INNORY-1001
    D.3.9.1CAS number 1431303-72-8
    D.3.9.3Other descriptive nameORY-1001
    D.3.9.4EV Substance CodeSUB124833
    D.3.10 Strength
    D.3.10.1Concentration unit µg/m2 microgram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number60 to 140
    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 Yes
    D.2.1.1.1Trade name Azacitidine
    D.2.1.1.2Name of the Marketing Authorisation holderAzacitidine
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAzacitidine
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZACITIDINE
    D.3.9.1CAS number 320-67-2
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with acute mieloyd leukemia (AML)
    Pacientes con leucemia mieloide aguda (LMA)
    E.1.1.1Medical condition in easily understood language
    Patients with acute mieloyd leukemia
    Pacientes con leucemia mieloide aguda
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10024349
    E.1.2Term Leukemia myeloid
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To asses safety, tolerability and dose finding of ORY-1001 in combination with azacitidine.
    Evaluar la seguridad, la tolerabilidad y la búsqueda de dosis de ORY-1001 en combinación con azacitidina.
    E.2.2Secondary objectives of the trial
    -Time to response (time from the start of treatment with ORY-1001 to the first objective tumor response observed in terms of number of cycles administered)
    -Duration of response d(the time from the first occurrence of a documented objective response to the time of progression or death from any cause, whichever occurs first)
    -Objetive response (number of subjects achieving complete remission, CR with incomplete recovery, partial remission, confirmed by repeat assessments ≥ 4 weeks after initial documentation)
    -Hematologic improvement (hematologic improvements of some cellular line that allow patient improve their quality of life)
    -Event–Free Survival (time from first study treatment to disease progression or death)
    -Overall Survival (the time from first study treatment to death from any cause)
    -To monitor ORY-1001 exposure and accumulation at steady state
    -To monitor ORY-1001 pharmacodynamics in terms of LSD1 target engagement in peripheral blood mononuclear cells
    - Tiempo de respuesta (tiempo desde inicio del tto con ORY-1001 hasta la 1ª respuesta tumoral objetiva observada en nº de ciclos admtrados)
    -Duración de respuesta (tiempo desde la 1ª aparición de una respuesta objetiva docum al momento de progresión o muerte, lo que ocurra primero)
    -Respuesta objetiva (nº de sujetos que logran remisión completa, RC con recuperación incompleta, remisión parcial, confirmada por evaluaciones repetidas ≥ 4 semanas después de la docum inicial)
    -Mejora hematológica (de alguna línea celular que permiten al paciente mejorar su calidad de vida)
    -Supervivencia Libre de Eventos (tiempo desde el primer tto del estudio hasta la progresión de la enfermedad o la muerte)
    - Supervivencia global (tiempo desde el 1º tto del estudio hasta la muerte)
    - Controlar la exposición y acumulación de ORY-1001 en estado estacionario (FC)
    - Controlar la farmacodinámica de ORY-1001 respecto a la activación de la diana LSD1 en las cél. mononucleares de sangre periférica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects ≥ 60 years of age with AML according to World Health Organization (WHO) classification, who are considered by the investigator ineligible for intensive chemotherapy regimen at that time or have refused standard chemotherapy.
    2. Blasts at least 20% of bone marrow and/or ≥ 20 % in peripheral blood.
    3. Subjects may not have received prior treatment for AML other than Hydroxyurea.
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
    5. Platelets ≥ 100 x10e9/ L without transfusion (in the opinion of the investigator).
    6. Chemical laboratory parameters within the following range:
    a. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x the upper limit of normal (ULN).
    b. Total bilirubin ≤ 1.5 x the ULN; patients with Gilbert’s syndrome can enroll if conjugated bilirubin is within normal limits.
    7. Patients with preserved renal function: serum creatinine ≤ 1.5 mg /dl.
    8. Patients must be capable of understanding and complying with protocol requirements, and they must be able and willing to sign a written informed consent, and willing to complete all scheduled visits and assessments at the institution administering.
    9. Life expectancy of at least 3 months in the opinion of the investigator.
    1. Sujetos ≥60 años de edad con LMA según la clasificación de la Organización Mundial de la Salud (OMS), que el investigador considera que no son aptos para la pauta de quimioterapia intensiva en ese momento o que han rechazado la quimioterapia estándar.
    2. Blastos: al menos un 20 % en la médula ósea o ≥20 % en la sangre periférica.
    3. Los sujetos no pueden haber recibido tratamiento previo para la LMA aparte de hidroxiurea.
    4. Estado funcional del Grupo Oncológico Cooperativo del Este (ECOG) de 0-2.
    5. Plaquetas ≥100 x10e9/l sin transfusión (bajo criterio médico).
    6. Valores analíticos bioquímicos dentro del siguiente rango:
    a. Aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) ≤3 veces el límite superior de la normalidad (LSN).
    b. Bilirrubina total ≤1,5 veces el LSN; los pacientes con síndrome de Gilbert pueden inscribirse si la bilirrubina conjugada se encuentra dentro de los límites normales.
    7. Creatinina sérica ≤1,5 veces el LSN.
    8. Los pacientes deben ser capaces de comprender y cumplir los requisitos del protocolo, además de poder y estar dispuestos a firmar un consentimiento informado por escrito, así como estar dispuestos a realizar todas las visitas y evaluaciones programadas en la institución que las administra.
    9. Esperanza de vida de al menos 3 meses según la opinión del investigador.
    E.4Principal exclusion criteria
    1. Malignancies other than AML within 1 year prior to start treatment, except for those that are in complete remission, no treatment is required and with a minimal risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ treated surgically with curative intent.
    2. Patients with uncontrolled hypertension (in the opinion of the investigator).
    3. Patients with uncontrolled diabetes (in the opinion of the investigator).
    4. Active hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
    5. Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
    6. Inter-current illness or social situation that will limit compliance with study requirements. Any serious underlying medical or psychiatric condition (e.g. alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the investigator would contraindicate the patient’s participation in the study or confound the results of the study.
    7. A physical exam or laboratory finding that contraindicates the use of investigational therapy or otherwise places the patient at excessively high risk for treatment, as determined by the Investigator.
    8. Patients medicated with anti-depressants reported to have KDM1A/LSD1 inhibitory activity: tranylcypromine or phenelzine.
    9. History of central nervous system (CNS) disease involvement or prior history of NCI CTCAE Grade ≥ 3 drug-related CNS toxicity.
    10. Evidence of active uncontrolled viral, bacterial, or systemic fungal infection. Prophylactic therapy according to institutional protocols is acceptable.
    11. Peripheral white blood cell (WBC) count ≥ 20 x 10e9/L on Day 1 prior to treatment. Hydroxyurea or 6-mercaptopurine are allowed until 24 hours prior study treatment start.
    12. Pregnant or lactating / breastfeeding women.
    13. Fertile women of childbearing potential (WCBP) not willing to use double barrier methods of contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) during the trial and 90 days after the end of treatment. Male patients whose partners are not willing to use double-barrier methods of contraception.
    1. Neoplasias malignas distintas de la LMA durante 1 año antes del inicio del tratamiento, excepto los que tienen remisión completa, no requieren tratamiento y con un riesgo mínimo de metástasis o muerte, como carcinoma localizado del cuello uterino tratado adecuadamente, cáncer de piel basocelular o espinocelular, cáncer de próstata localizado, carcinoma ductal localizado tratado quirúrgicamente con intención curativa.
    2. Pacientes con hipertensión no controlada (en opinión del investigador).
    3. Pacientes con diabetes no controlada (en opinión del investigador).
    4. Virus de la hepatitis C (VHC) o virus de la hepatitis B (VHB) activos. Los pacientes que son positivos para el anticuerpo de núcleo de la hepatitis B, el antígeno de superficie de la hepatitis B o el anticuerpo de la hepatitis C deben tener un resultado negativo en la reacción en cadena de polimerasa (RCP) antes de inscribirse. Se excluirá a los que tengan una RCP positiva.
    5. Resultado positivo conocido de la prueba del virus de la inmunodeficiencia humana (VIH) o el síndrome de inmunodeficiencia adquirida (SIDA).
    6. Enfermedad concomitante o situación social que limitará el cumplimiento de los requisitos del estudio. Cualquier enfermedad o trastorno psiquiátrico (por ejemplo, dependencia de alcohol o drogas) subyacente grave, demencia o alteración del estado mental o cualquier problema que pueda afectar a la capacidad del paciente para comprender el consentimiento informado o que, en opinión del investigador, contraindique la participación del paciente en el estudio o que pueda confundir los resultados del estudio.
    7. Exploración física o resultado analítico que contraindique el uso del tratamiento en investigación o ponga al paciente en un riesgo excesivamente alto para el tratamiento, según lo determine el investigador.
    8. Pacientes con medicamentos antidepresivos que tienen actividad inhibidora frente a KDM1A/LSD1: tranilcipromina o fenelzina.
    9. Antecedentes de afectación de la enfermedad al sistema nervioso central (SNC) o antecedentes de toxicidad farmacológica del SNC de grado ≥3 según NCI CTCAE.
    10. Evidencia de infección vírica, bacteriana o fúngica sistémica activa no controlada. Se acepta el tratamiento profiláctico de acuerdo con los protocolos del centro.
    11. Recuento de leucocitos (LEU) periféricos ≥20 x 10e9/l el día 1 antes del tratamiento. Se permite hidroxiurea o 6-mercaptopurina hasta 24 horas antes de iniciar el tratamiento del estudio.
    12. Mujeres embarazadas o en período de lactancia.
    13. Mujeres en edad fértil (MEF) que no estén dispuestas a utilizar métodos anticonceptivos de doble barrera (abstinencia, anticonceptivos orales, dispositivo intrauterino o método anticonceptivo de barrera junto con gelatina espermicida, o quirúrgicamente estériles) durante el ensayo y 90 días después de finalizar el tratamiento. Pacientes masculinos cuyas parejas no estén dispuestas a usar métodos anticonceptivos de doble barrera.
    E.5 End points
    E.5.1Primary end point(s)
    Dose finding, safety and tolerability of combo therapy.
    Determinación de la dosis, seguridad y tolerabilidad del tratamiento combinado.
    E.5.1.1Timepoint(s) of evaluation of this end point
    until disease progression or unacceptable toxicities
    hasta progresión o toxicidades inaceptables
    E.5.2Secondary end point(s)
    1. Time to first response (TTR) of combo therapy.
    2. Duration of response (DOR) of combo therapy.
    3. Objetive response (OR) of combo therapy.
    4. Hematologic improvement (HI) of combo therapy.
    5. Event – Free Survival (EFS) of combo therapy.
    6. Overall Survival (OS) of combo therapy.
    7. To monitor ORY-1001 pharmacokinetics (PK).
    8. To monitor ORY-1001 pharmacodynamics (PD) in terms of LSD1 target engagement in peripheral blood mononuclear cells (PBMCs).

    Exploratory endpoints
    1. Determination of gene expression changes in response to ORY-1001 for specific biomarkers.
    2. Morphological differentiation observed in blasts in PB and BM.
    1. Tiempo hasta la respuesta (THR) del tratamiento combinado
    2. Duración de la respuesta (DR) del tratamiento combinado
    3. Respuesta objetiva (RO) del tratamiento combinado
    4. Mejora hematológica (MH) del tratamiento combinado
    5. Supervivencia libre de eventos (SLE) del tratamiento combinado
    6. Supervivencia global (SG) del tratamiento combinado
    7. Determinación de los niveles plasmáticos mínimos de ORY-1001 (FC)
    8. Determinación de los niveles de activación de la diana LSD1 en las CMSP (FD)

    Criterios de valoración exploratorios
    1. Determinación de cambios en la expresión génica en respuesta a ORY-1001 en biomarcadores específicos
    2. Diferenciación morfológica observada en blastos en la SP y la MO.
    E.5.2.1Timepoint(s) of evaluation of this end point
    until disease progression or unacceptable toxicities
    hasta progresión o toxicidades inaceptables
    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 Yes
    E.6.10Pharmacogenetic Yes
    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) No
    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.8.3 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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LPLV
    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 months3
    E.8.9.1In the Member State concerned days
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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)
    According medical practice
    Acorde a práctica clínica habitual
    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 Decision2018-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-25
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-Sat Sep 22 15:36:25 BST 2018 | 30 Churchill Place, Canary Wharf, London E14 5EU
    Legal notice
    EMA HMA