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   36827   clinical trials with a EudraCT protocol, of which   6080   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:2016-002057-38
    Sponsor's Protocol Code Number:64091742PCR2001
    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:2016-08-17
    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 number2016-002057-38
    A.3Full title of the trial
    A Phase 2 Efficacy and Safety Study of Niraparib in Men with Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
    Estudio fase 2 de eficacia y seguridad de Niraparib en hombres con cáncer
    de próstata metastásico resistente a castración y anomalías en la
    reparación de ADN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to understand the effect of Niraparib in men with end-stage PCA+
    Estudio para entender el efecto de Niraparib en hombres con cáncer de
    próstata en fase avanzada
    A.3.2Name or abbreviated title of the trial where available
    GALAHAD
    GALAHAD
    A.4.1Sponsor's protocol code number64091742PCR2001
    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 SponsorJanssen-Cilag International N.V.
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917228100
    B.5.5Fax number+34917228628
    B.5.6E-mailagonza45@its.jnj.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNiraparib 100 mg capsules
    D.3.2Product code JNJ-64091742
    D.3.4Pharmaceutical form Capsule
    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 INNNIRAPARIB
    D.3.9.1CAS number 1038915-60-4
    D.3.9.2Current sponsor codeJNJ-64091742
    D.3.9.3Other descriptive nameniraparib tosylate monohydrate
    D.3.9.4EV Substance CodeSUB177208
    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.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
    mCRPC and DNA-repair anomalies
    Cáncer de próstata metastásico y resistente a castración y anomalías de
    reparación del ADN.
    E.1.1.1Medical condition in easily understood language
    Prostate cancer in adult men that has spread to other parts of the body
    Hombres adultos con cáncer de próstata extendido a otras partes del
    cuerpo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of niraparib in subjects with mCRPC and DNA-repair anomalies.
    Evaluar la eficacia de Niraparib en sujetos con cáncer de próstata
    metastásico resistente a castración y anomalías en la reparación del ADN
    E.2.2Secondary objectives of the trial
    -To evaluate response outcomes of niraparib in subjects with mCRPC and DNA-repair anomalies.
    -To evaluate the safety and tolerability of niraparib.
    -To evaluate duration of tumor response.
    - Evaluar las variables de respuesta de Niraparib en sujetos con cáncer
    de próstata metastásico resistente a castración y anomalías en la
    reparación del ADN
    - Evaluar la seguridad y tolerabilidad de Niraparib
    - Evaluar la duración de la respuesta tumoral
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male
    2. >18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
    3. Signed main study ICF indicating that the subject understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    4. Histologically confirmed prostate cancer (mixed histology is acceptable).
    5. At least 1 line of taxane-based chemotherapy for the treatment of prostate cancer.
    6. At least 1 line of AR-targeted therapy (eg, abiraterone acetate, enzalutamide, apalutamide) for prostate cancer.
    7. Biomarker-positive sample for DNA-repair anomalies.
    8. Progression of metastatic prostate cancer in the setting of castrate levels of testosterone ≤50 ng/dL on a gonadotropin releasing hormone analog (GnRHa), or history of bilateral orchiectomy at study entry defined as having one or more of the following:
    a. PSA progression defined by a minimum of 2 rising PSA levels with an interval of ≥1 week between each determination. The PSA level at the screening visit should be ≥2 μg/L (2 ng/mL).
    b. Radiographic progression of soft tissue or bone disease by Prostate Cancer
    Working Group 3 (PCWG3) criteria.
    9. Must continue GnRHa during the course of the study if not surgically castrate.
    10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤2.
    11. Must be able to swallow whole capsules.
    12. Subject must agree to use medically accepted and highly effective methods of contraception during the course of the study and for 3 months after the last dose of study drug.
    13. To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must agree while on study drug and for 3 months following the last dose of study drug to:
    a. Use a condom during sexual activity.
    b. Not donate sperm.
    14. At screening, the following laboratory parameters must be met:
    a. Absolute neutrophil count (ANC) ≥1.5 x 10^9/L
    b. Hemoglobin ≥9.0 g/dL
    c. Platelet count ≥150 x 10^9/L
    d. Serum albumin ≥2.5 g/dL
    e. Serum creatinine ≤1.5 × upper limit of normal (ULN), or a calculated
    creatinine clearance ≥60 mL/min using the Cockcroft-Gault equation
    f. Serum potassium ≥3.5 mmol/L
    g. Serum total bilirubin ≤1.5 × ULN or direct bilirubin ≤1 x ULN (Note: in
    subjects with Gilbert’s syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin, and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
    h. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
    ≤3.0 × ULN or ≤5 x ULN in the presence of liver metastases
    1. Varón
    2. Edad mínima de 18 años (o la edad legal de consentimiento en la
    jurisdicción en que se lleve a cabo el estudio).
    3. Documento de consentimiento informado para el estudio principal
    firmado que indique que el sujeto entiende la finalidad del estudio y los
    procedimientos que exige, así como que está dispuesto a participar en él.
    4. Cáncer de próstata confirmado histológicamente (la histología mixta
    será aceptable).
    5. Al menos una línea de quimioterapia a base de taxanos para el
    tratamiento del cáncer de próstata.
    6. Al menos una línea de tratamiento dirigido contra los receptores de
    andrógenos (por ejemplo, acetato de abiraterona, enzalutamida o
    apalutamida) para el cáncer de próstata.
    7. Muestra con biomarcadores positivos para anomalías de reparación
    del ADN (véase la sección 9.7).
    8. Progresión del cáncer de próstata metastásico en el contexto de unas
    concentraciones de testosterona en nivel de castración ≤ 50 ng/dl con
    un análogo de la hormona liberadora de gonadotropina (aGnRH) o
    antecedentes de orquiectomía bilateral al inicio del estudio, definida
    como la presencia de una o más de las circunstancias siguientes:
    a. Progresión del PSA, definida por un mínimo de dos concentraciones
    crecientes de PSA obtenidas con un intervalo ≥ 1 semana entre cada
    determinación. La concentración de PSA en la visita de selección debe
    ser ≥ 2 μg/L (2 ng/mL)
    b. Progresión radiológica de la enfermedad de tejido blando u ósea
    conforme a los criterios del Prostate Cancer Working Group 3
    (PCWG3)17.
    9. El tratamiento con aGnRH deberá mantenerse durante el estudio en
    caso de que el sujeto no esté castrado quirúrgicamente.
    10. Estado funcional del Eastern Cooperative Oncology Group (ECOG) ≤ 2
    (véase el apéndice 3).
    11. Capacidad de tragar cápsulas enteras.
    12. Compromiso del sujeto a utilizar métodos anticonceptivos
    médicamente aceptados y sumamente eficaces durante el estudio y
    hasta tres meses después de la última dosis del fármaco del estudio.
    13. A fin de evitar el riesgo de exposición al fármaco a través del
    eyaculado (incluso de varones con vasectomía), los sujetos deberán
    comprometerse durante el tratamiento con el fármaco del estudio y
    hasta tres meses después de la última dosis a:
    a. Utilizar preservativo durante las relaciones sexuales.
    b. No donar semen.
    14. En la selección, deberán cumplirse los siguientes parámetros
    analíticos:
    a. Recuento absoluto de neutrófilos (RAN) ≥ 1,5 x 109/l.
    b. Hemoglobina ≥ 9,0 g/dl.
    c. Recuento de plaquetas ≥ 150 x 109/l.
    d. Albúmina sérica ≥ 2,5 g/dl.
    e. Creatinina sérica ≤ 1,5 veces el límite superior de la normalidad (LSN)
    o aclaramiento de creatinina calculado ≥ 60 ml/min según la ecuación de
    Cockcroft-Gault.
    f. Potasio sérico ≥ 3,5 mmol/l.
    g. Bilirrubina total en suero ≤ 1,5 veces el LSN o bilirrubina directa ≤ 1
    vez el LSN. (Nota: En los sujetos con síndrome de Gilbert, si la bilirrubina
    total es > 1,5 veces el LSN, habrá que medir la bilirrubina directa e
    indirecta y, si la bilirrubina directa es ≤ 1,5 veces el LSN, el sujeto podrá
    participar en el estudio).
    h. Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) ≤
    3,0 veces el LSN, o ≤ 5 veces el LSN en presencia de metástasis
    hepáticas.
    E.4Principal exclusion criteria
    1. Prior treatment with a PARP inhibitor.
    2. Prior platinum-based chemotherapy.
    3. Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
    4. Known symptomatic or impending cord compression, except if subject has received definitive treatment for this and demonstrates evidence of clinically stable disease.
    5. Known symptomatic uncontrolled brain or leptomeningeal metastases (controlled is defined as CNS disease which has undergone treatment [eg, radiation or surgery] at least 15 days prior to Cycle 1 Day 1).
    6. Known allergies, hypersensitivity, or intolerance to niraparib or its excipients (refer to Investigator's Brochure).
    7. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
    8. Known disorder affecting gastrointestinal absorption.
    9. Active cancer (other than prostate cancer; or basal cell or squamous cell skin cancer, non-muscle invasive bladder cancer [stages pTaG1 and pTaG2], or any other cancer in situ currently in complete remission) within 2 years prior to Cycle 1 Day 1.
    10. Prior radiotherapy ≤15 days prior to Cycle 1 Day 1, with the exception of a single fraction of radiotherapy for the purposes of palliation, which is permitted.
    11. Prolonged corrected QT interval by the Fridericia correction formula (QTcF) on the screening ECG >470 msec.
    12. Receiving concomitant medications that prolong QTc and are unable to discontinue use while receiving study drug.
    13. History of clinically significant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsade’s de pointes).
    14. HIV positive subjects with 1 or more of the following:
    a. Not receiving highly active antiretroviral therapy
    b. A change in antiretroviral therapy within 6 months of the start of screening(except if, after consultation with the sponsor on exclusion criterion 14.c, a change is made to avoid a potential drug-drug interaction with the study drug)
    c. Receiving antiretroviral therapy that may interfere with the study drug consult the sponsor for review of medication prior to enrollment)
    d. CD4 count <350 at screening
    e. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening
    15. ≤30 days prior to Cycle 1 Day 1 received or had:
    a. a transfusion (platelets or red blood cells)
    b. chemotherapy
    c. hematopoietic growth factors
    d. an investigational agent for prostate cancer
    e. major surgery
    f. new or adjusted dose of zoledronic acid or denosumab
    1. Tratamiento previo con un inhibidor de la PARP.
    2. Quimioterapia previa a base de platino.
    3. Antecedentes o diagnóstico presente de síndrome mielodisplásico
    (SMD)/leucemia mieloide aguda (LMA).
    4. Compresión medular sintomática o inminente conocida, excepto si el
    sujeto ha recibido tratamiento definitivo para ella y presenta indicios de
    enfermedad clínicamente estable.
    5. Metástasis cerebrales o leptomeníngeas sintomáticas y no controladas
    conocidas («controladas» se define como enfermedad del SNC que ha
    recibido tratamiento [por ejemplo, radioterapia o intervención
    quirúrgica] al menos 15 días antes del día 1 del ciclo 1).
    6. Alergia, hipersensibilidad o intolerancia conocida a niraparib o sus
    excipientes (véase el manual del investigador)12.
    7. Cualquier condición por la que, en opinión del investigador, la
    participación en el estudio no sea lo mejor para el sujeto (por ejemplo,
    afectaría a su bienestar) o pueda impedir, limitar o constituir un factor
    de confusión en las evaluaciones especificadas en el protocolo.
    8. Trastorno conocido que afecte a la absorción gastrointestinal.
    9. Cáncer activo (distinto del cáncer de próstata; o carcinoma
    basocelular o cáncer de piel de células escamosas, cáncer de vejiga sin
    invasión muscular [estadios pTaG1 y pTaG2] o cualquier otro cáncer in
    situ en situación de remisión completa) en los dos años previos al día 1
    del ciclo 1.
    10. Radioterapia en los 15 días previos al día 1 del ciclo 1, a excepción
    de una sola fracción de radioterapia paliativa, que estará permitida.
    11. Intervalo QT corregido prolongado según la fórmula de corrección de
    Fridericia (QTcF) en el ECG de selección > 470 ms.
    12. Tratamiento con medicamentos concomitantes que prolongan el
    intervalo QTc e imposibilidad de suspender su uso mientras se
    administre el fármaco del estudio.
    13. Antecedentes de arritmias ventriculares con importancia clínica (por
    ejemplo, taquicardia ventricular, fibrilación ventricular o taquicardia
    helicoidal).
    14. Infección por el VIH con una o más de las circunstancias siguientes:
    a. El sujeto no está recibiendo tratamiento antirretroviral de gran
    actividad.
    b. Modificación del tratamiento antirretroviral en los 6 meses previos al
    inicio de la selección (excepto si, tras consultar al promotor en relación
    con el criterio de exclusión 14.c, la modificación se ha hecho para evitar
    una interacción farmacológica con el fármaco del estudio).
    c. Recepción de tratamiento antirretroviral que pueda interferir con el
    fármaco del estudio (ha de consultarse al promotor para que revise la
    medicación antes del reclutamiento).
    d. Recuento de CD4 < 350 en la visita de selección.
    e. Infección oportunista que defina síndrome de inmunodeficiencia
    adquirida en los 6 meses previos al inicio de la selección.
    15. En los 30 días previos al día 1 del ciclo 1, el sujeto ha recibido o se ha
    sometido a:
    a. Una transfusión (plaquetas o eritrocitos).
    b. Quimioterapia.
    c. Factores de crecimiento hematopoyéticos.
    d. Un fármaco en investigación para el cáncer de próstata.
    e. Intervención quirúrgica mayor.
    f. Dosis nueva o ajustada de ácido zoledrónico o denosumab.
    E.5 End points
    E.5.1Primary end point(s)
    Response rate (RR): defined as 1 of the following by PCWG3
    -Objective response (confirmed per RECIST 1.1), or
    -Conversion of CTC from ≥5 cells per 7.5 mL blood at baseline to <5 cells per 7.5 mL blood nadir, confirmed by a second consecutive value obtained 4 or more weeks later, or
    -PSA decline of ≥50%, measured twice 3 to 4 weeks
    apart
    Tasa de respuesta (TR): definida como una de las circunstancias
    siguientes según los criterios del PCWG3:
    - Respuesta objetiva (confirmada conforme a los criterios RECIST 1.1)
    - Conversión de CTC de ≥ 5 células por 7,5 ml de sangre en el momento
    basal a < 5 células por 7,5 ml de sangre en el nadir, confirmada por un
    segundo valor consecutivo obtenido un mínimo de 4 semanas después
    - Disminución del PSA ≥ 50%, determinado dos veces con 3 a 4 semanas
    de diferencia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Final analysis for the RR will occur approximately 18 months from first subject enrolled
    El análisis final de la TR tendrá lugar aproximadamente 18 meses
    después del reclutamiento del primer sujeto
    E.5.2Secondary end point(s)
    OS: time from enrollment to death from any cause
    - rPFS: time from enrollment to radiographic progression or death from any cause, whichever occurs first
    -Time to radiographic progression
    -Time to PSA progression
    -Time to symptomatic skeletal event (SSE)
    -Duration of objective response: time from complete response (CR) or partial response (PR) to radiographic progression of disease
    SG: tiempo transcurrido entre el reclutamiento y la muerte por cualquier
    causa
    - SSPr: tiempo transcurrido entre el reclutamiento y la progresión
    radiológica o la muerte por cualquier causa, lo que ocurra antes
    - Tiempo hasta la progresión radiológica
    - Tiempo hasta la progresión del PSA
    - Tiempo hasta la aparición de episodios óseos sintomáticos (EOS)
    - Duración de la respuesta objetiva: tiempo transcurrido entre la
    respuesta completa (RC) o parcial (RP) y la progresión radiológica de la
    enfermedad
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not answered
    No contestado
    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 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.8.2.4Number 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    Belgium
    Canada
    Denmark
    France
    Germany
    Italy
    Korea, Republic of
    Netherlands
    Russian Federation
    Spain
    Sweden
    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
    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 months4
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days10
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female No
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 51
    F.4.2.2In the whole clinical trial 100
    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 a subject has completed the Treatment Phase, survival follow-up and SSEs will be performed every 3 months either via clinic visits, telephone interview, chart review, or other convenient methods. Deaths regardless of causality and SAEs thought to be related to study drugs will be collected and reported within 24 hours of discovery or notification of the event.
    Una vez el sujeto ha completado la fase de tratamiento, el seguimiento
    de la supervivencia y de los episodios óseos se realizará cada 3 meses mediante visitas presenciales, telefónicas, revisión de historia médica u otros métodos convenientes. La muerte por cualquier causa y AAGs que se crea están relacionados con el fármaco del estudio serán recogidos y notificados dentro de las 24 horas desde la detección o notificación del evento.
    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 Decision2016-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-19
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA