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    Summary
    EudraCT Number:2018-001054-96
    Sponsor's Protocol Code Number:000013/BT
    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:2020-05-15
    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 number2018-001054-96
    A.3Full title of the trial
    Phase IIb, Placebo-Controlled, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB) Single Implantation in Tibial Fracture
    Estudio de fase IIb, multicéntrico, aleatorizado, con doble enmascaramiento y comparativo con placebo, para evaluar la eficacia y la seguridad de un único implante de osteoblastos alogénicos (ALLOB®) en la fractura de tibia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Efficacy and Safety of ALLOB in Tibial Fracture
    Estudio para evaluar la eficacia y la seguridad de ALLOB en la fractura de tibia
    A.3.2Name or abbreviated title of the trial where available
    ALLOB-TF2
    A.4.1Sponsor's protocol code number000013/BT
    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 SponsorBone Therapeutics S.A.
    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 supportBone Therapeutics S.A.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBone Therapeutics S.A.
    B.5.2Functional name of contact pointClinical Trial Team
    B.5.3 Address:
    B.5.3.1Street AddressRue Auguste Piccard, 37
    B.5.3.2Town/ cityGosselies
    B.5.3.3Post code6041
    B.5.3.4CountryBelgium
    B.5.6E-mailallob.tf2@bonetherapeutics.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 nameALLOB
    D.3.2Product code ALLOB
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPercutaneous use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALLOB cells
    D.3.9.2Current sponsor codeALLOB cells
    D.3.9.3Other descriptive nameAllogeneic bone-marrow-derived osteoblasts
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberIt has been classified as a tissue engineering product (non-combined) (reference : EMA/647468/2011) by the EMA on July 19, 2011 (as defined in Article 2(1)(a-d) of Regulation (EC) No 1394/2007)
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboPercutaneous use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Tibial fracture considered at risk of DU/NU (based on the combination of risk factors documented to be associated with increased proportion of DU/NU).
    Fractura de tibia con riesgo de RC/SA (determinado teniendo en cuenta la combinación de factores de riesgo que, según se ha demostrado, se asocian a una mayor proporción de RC/SA).
    E.1.1.1Medical condition in easily understood language
    Tibial fracture considered at risk of Delay union/non union
    Fractura de tibia con riesgo de retraso de consolidación/seudoartrosis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10043827
    E.1.2Term Tibia fracture
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that treatment with ALLOB leads to a significant improvement in radiological success with respect to placebo in subjects with a tibial fracture.
    Demostrar que el tratamiento con ALLOB conlleva una mejoría significativa en el éxito radiológico con respecto al placebo en los pacientes que han sufrido una fractura de tibia.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - To assess the impact of ALLOB on the speed of fracture healing, radiological fracture healing and clinical fracture healing
    - To assess the impact of ALLOB on the rate of fracture healing, radiological fracture healing, clinical fracture healing, DU and NU
    - To assess the impact of ALLOB on the rate of rescue intervention due to tibial DU and NU
    - To assess the impact of ALLOB on functional status and return to normal activities
    - To assess the impact of ALLOB on RUST score
    - To assess the accuracy of RUST threshold value predictive of bone healing
    - To demonstrate the overall safety of ALLOB particularly based on key safety outcomes (product failure, infection related to implantation, hypersensitivity reaction, ectopic bone formation)
    Objetivos secundarios
    - Evaluar efecto de ALLOB en la rapidez de consolidación de la fractura, consolidación radiológica de la fractura y consolidación clínica de la fractura
    - Evaluar efecto de ALLOB en el índice de consolidación de la fractura, consolidación radiológica de la fractura, consolidación clínica de la fractura, retraso de consolidación (RC) y seudoartrosis (SA)
    - Evaluar efecto de ALLOB en el índice de intervención de rescate debido a un RC o una SA de la tibia
    - Evaluar efecto de ALLOB en el estado funcional y regreso a las actividades habituales
    - Evaluar efecto de ALLOB en la puntuación obtenida en la escala RUST
    - Evaluar la exactitud del valor umbral predictivo de la consolidación de la fractura de la escala RUST
    - Demostrar la seguridad global de ALLOB, especialmente tomando como base los criterios clave de valoración de seguridad (ineficacia del producto, infección relacionada con la implantación, reacción de hipersensibilidad y osificación ectópica)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects must satisfy ALL of the following criteria to be included in the study:
    1. Men and women at least 18 years of age
    2. Subject diagnosed with a fresh proximal, midshaft or distal tibial fracture with definitive reduction performed with nail(s) and wound closure within 1 week of fracture occurrence
    3. Mechanism of injury at risk of DU/NU: fracture occurring because of a high energy impact
    4. At increased risk of DU/NU defined by: Severe open fracture (Gustilo-Anderson grade IIIa and IIIb) OR Open (Gustilo-Anderson grade I-II) or closed (Tscherne grade II-III) fracture with at least one additional risk factor among smoking, comminuted fracture or cortical continuity (0-50%)
    5. Ability to obtain a written, dated, and signed informed consent prior to any study related procedures and ability to understand and comply with study requirements
    Para poder incorporarse al estudio, los pacientes deben cumplir TODOS los criterios siguientes:
    1. Personas de ambos sexos de al menos 18 años
    2. Diagnóstico de fractura reciente del tercio proximal, medio o distal de la tibia y una cirugía de reducción definitiva con clavo(s) y cierre de la herida en el plazo de 1 semana desde que se produjo la fractura
    3. Mecanismo de lesión con riesgo de RC/SA: la fractura es secundaria a un traumatismo de alta energía
    4. Un riesgo elevado de RC/SA, que se define como:
    Fractura abierta grave (grados IIIa y IIIb de Gustilo y Anderson)
    O BIEN
    Fractura abierta (grados I-II de Gustilo y Anderson) o cerrada (grados II-III de Tscherne) con al menos un factor de riesgo adicional de entre los siguientes: tabaquismo, fractura conminuta o continuidad cortical (0-50 %)
    5. Capacidad para otorgar su consentimiento informado por escrito, fechado y firmado, antes de realizar cualquier procedimiento del estudio, además de la capacidad para entender los requisitos del estudio y cumplirlos
    E.4Principal exclusion criteria
    Current symptoms and/or signs related to the disease under study:
    1. Definitive reduction at the fracture site under investigation performed with plate, screw or external fixator
    2. Subjects who did not receive a standard antibiotic prophylaxis before definitive reduction at the fracture site under investigation
    3. Intra-articular tibial pilon and/or plateau fracture at the site under investigation
    4. Known osteomyelitis at the fracture site under investigation
    5. Bone defect post-definitive reduction greater than 1cm at least on 2 cortices at the fracture site under investigation
    6. Fracture requiring vascular surgery at the site under investigation
    7. Pathological fractures as judged by the Investigator, such as tumor or metabolic bone disease
    8. Bifocal or multifocal fracture at the site under investigation

    Current or previous diagnoses, signs and/or symptoms:
    9. Presence of fever (defined as body temperature ≥ 38°C) or other signs/symptoms suggestive of active infection before randomization
    10. Severe brain trauma with a Glasgow Coma Scale (GCS) [3 – 8] or severe spinal cord injury with impossibility of weight-bearing
    11. Current or history (within 5 years) of any neoplasia (except for basal cell carcinoma of the skin and for carcinoma in situ of the cervix that has been treated with no evidence of recurrence)
    12. Known metabolic diseases potentially interfering with bone healing as judged by the Investigator, such as thyroid dysfunction, Paget disease or severe osteoporosis
    13. Planned or history of solid organ transplantation or bone marrow transplantation
    14. Known disease, including genetic disease, that may possibly need solid organ transplantation
    15. Subject with renal impairment requiring dialysis or with clinically significant renal impairment defined as serum creatinine >2.0 x ULN
    16. Clinically significant hepatic function impairment defined as ALT/AST levels > 3x ULN or total bilirubin levels > 2 x ULN
    17. Known hematologic disease as evidenced by hematocrit < 25%, white blood cell < 2,500/ul or platelet values < 100,000/ul without another explanation
    18. Subject with an history of long standing poorly controlled chronic hypertension or diabetes that could put him at risk of needing a kidney transplant later on according to the Investigator
    19. History of hypersensitivity to human biological material including blood and blood derived products
    20. Known allergy to DMSO, dextran, gentamicin and any other aminoglycosides

    Current or previous treatment:
    21. Participation in another interventional clinical study within 3 months prior to screening
    22. Any chronic intake of medication within one month that might affect bone metabolism or the quality of bone formation such as but not limited to bisphosphonates, teriparatide, systemic steroids, anticoagulant therapies, methotrexate and other immunosuppressant drugs or related immunotherapy
    23. Previous (within 10 years) treatment with bisphosphonates
    24. Current treatment with bone morphogenic protein or any other osteo-biologic intervention at the site of the tibial fracture

    Safety aspects concerning female subjects of childbearing potential
    25. Breast-feeding
    26. Pregnancy
    27. Woman with positive urine pregnancy test at screening
    28. Woman not willing or not able to use a reliable contraceptive method during the active study follow-up period. Reliable contraceptive methods exclusively highly effective birth control methods: a. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) b. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) c. Intrauterine device d. Intrauterine hormone-releasing system e. Bilateral tubal occlusion

    Other exclusion criteria:
    29. Life expectancy less than 12 months at screening
    30. Signs of an active drug or alcohol dependence, serious current illness, mental illness or any other factors which, in the opinion of the Investigator, may interfere with subject’s ability to understand and comply with study requirements, as judged by the Investigator
    31. Prisoner
    Síntomas o signos actuales relacionados con la enfermedad en estudio

    1.Realización de una reducción definitiva en el lugar de la fractura en investigación con placas, tornillos o fijadores externos
    2.Pacientes que no recibieron la prevención antibiótica habitual antes de la reducción definitiva en el lugar de la fractura en investigación
    3.Fractura de la meseta o el pilón tibial intrarticular en el lugar en investigación
    4.Osteomielitis conocida en el lugar de la fractura en investigación
    5.Defecto óseo posterior a la reducción definitiva superior a 1 cm en un mínimo de 2 cortezas en el lugar de la fractura en investigación
    6.Fractura que requiere cirugía vascular en el lugar en investigación
    7.Fracturas espontáneas, según el criterio del investigador, tales como tumores u osteopatía metabólica
    8.Fractura bifocal o multifocal en el lugar en investigación

    Diagnósticos, signos o síntomas actuales o anteriores

    9.Presencia de fiebre (definida como una temperatura corporal >=38 °C) u otros signos o síntomas indicativos de infección activa antes de la aleatorización
    10.Traumatismo craneoencefálico grave con una puntuación de 3 a 8 en la escala de coma de Glasgow (Glasgow Coma Scale, GCS) o lesión medular grave con imposibilidad de soportar cargas
    11.Presencia o antecedentes (durante los 5 últimos años) de cualquier neoplasia (excepto carcinoma basocelular y carcinoma localizado del cuello uterino que ha sido tratado y no muestra signos de recidiva)
    12.Metabolopatías conocidas que pueden interferir con la consolidación ósea según el criterio del investigador, tales como la disfunción tiroidea, la enfermedad de Paget o la osteoporosis grave
    13.Antecedentes de trasplante de vísceras macizas o de médula ósea o tener previsto someterse a uno
    14.Enfermedad conocida, incluidas las genéticas, que pueda requerir un trasplante de vísceras macizas
    15.Insuficiencia renal que requiere diálisis o insuficiencia renal clínicamente significativa definida como un valor de creatinina sérica >2,0 veces el LSN
    16.Insuficiencia hepática clínicamente significativa definida como valores de ALT/AST >3 veces el LSN o valores de bilirrubina total >2 veces el LSN
    17.Hemopatía conocida corroborada por valores de hematocrito <25 %, leucocitos <2500/μl o trombocitos <100 000/μl en ausencia de otra explicación
    18.Antecedentes de diabetes o hipertensión crónica de larga duración mal controlada que podría poner al paciente en riesgo de requerir un trasplante renal más adelante, según el criterio del investigador
    19.Antecedentes de hipersensibilidad a sustancias biológicas de origen humano, incluidos sangre y hemoderivados
    20.Alergia conocida a DMSO, dextrano, gentamicina o cualquier otro aminoglucósido

    Tratamiento actual o anterior

    21.Haber participado en otro estudio clínico de intervención durante los 3 meses previos a la selección
    22.Cualquier ingesta crónica de medicación durante el último mes que pueda influir en el metabolismo óseo o en la calidad de la osificación, como, por ejemplo, bisfosfonatos, teriparatida, corticoides sistémicos, tratamientos anticoagulantes, metotrexato y otros inmunodepresores o inmunoterapias relacionadas
    23.Tratamiento anterior (durante los 10 últimos años) con bisfosfonatos
    24.Tratamiento actual con proteína morfogenética ósea o cualquier otra intervención osteobiológica en el lugar de la fractura de tibia

    Aspectos de seguridad que afectan a las mujeres en edad fértil

    25.Lactancia
    26.Embarazo
    27.Resultado positivo en una prueba de embarazo en orina en la selección
    28.La mujer no desea o no puede utilizar un método anticonceptivo fiable durante el periodo de seguimiento activo del estudio. Métodos anticonceptivos fiables, exclusivamente métodos de control de la natalidad de gran eficacia:
    a.Anticonceptivos hormonales mixtos (que contengan estrógenos y gestágenos) asociados a la inhibición de la ovulación (orales, intravaginales o transdérmicos)
    b.Anticonceptivos hormonales gestagénicos asociados a la inhibición de la ovulación (orales, inyectables o implantables)
    c.Dispositivo intrauterino
    d.Sistema intrauterino de liberación de hormonas
    e.Oclusión bilateral de las trompas

    Otros criterios de exclusión

    29.Una esperanza de vida inferior a los 12 meses en la selección
    30.Signos de alcoholismo o drogodependencia activa, enfermedad grave en curso, enfermedad mental u otros factores que, según el criterio del investigador, puedan interferir en la capacidad del participante para entender los requisitos del estudio y cumplirlos
    31.Encontrarse recluido en prisión
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects with a radiological success at Week 12 (Visit #4). A radiological success is defined as a subject with a RUST score above the threshold value predictive of a normal bone healing. The threshold value that would best predict bone healing is hypothesized to be between 6 and 8 (on a scale from 4 to 12). It will be selected at an interim analysis by an Independent Data Monitoring Committee (IDMC) based on predefined decision rules.
    El criterio de valoración principal es la proporción de participantes que obtienen un éxito radiológico en la semana 12 (visita 4). El éxito radiológico de un participante se define como la obtención de una puntuación en la escala RUST que supere el valor umbral predictivo de una consolidación ósea normal. Se hipotetiza que el valor umbral que mejor predeciría la consolidación ósea es de entre 6 y 8 (en una escala de 4 a 12). Será seleccionado por un comité independiente de vigilancia de los datos (CIVD) en un análisis intermedio basándose en normas de decisión predefinidas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 semanas
    E.5.2Secondary end point(s)
    Efficacy endpoints:

    Key efficacy secondary endpoints:
    - Proportion of subjects with radiological success at Week 16 (Visit #5), Week 20 (Visit #6) and Month 6 (Visit #7)
    - Change in RUST at Week 12 (Visit #4), Week 16 (Visit #5), Week 20 (Visit #6) and Month 6 (Visit #7) compared to baseline visit

    Other efficacy secondary endpoints:
    - Time to fracture healing: based on Investigator judgement, fracture healing is defined by a full weight bearing of the treated tibia, a lack of pain at palpation, and a radiological fracture union. Radiological fracture union is defined by a bone bridging on at least three of the four cortices and absence of fracture line
    - Time to clinical fracture healing: based on Investigator judgement with the condition of a full weight bearing of the treated tibia and a lack of pain at palpation
    - Time to radiological fracture healing: performed by Independent Radiologists with the condition of a radiological fracture union
    - Proportion of subjects with fracture healing at each follow-up visit
    - Proportion of subjects with clinical fracture healing at each follow-up visit
    - Proportion of subjects with radiological fracture healing at each follow-up visit
    - Proportion of subjects with full weight-bearing at each follow-up visit
    - Time to rescue intervention
    - Time to full weight-bearing
    - Proportion of subjects requiring rescue intervention within 12 months
    - Proportion of subjects diagnosed with NU at Month 9 (Visit #8)
    - Proportion of subjects diagnosed with DU at Week 20 (Visit #6)
    - Pain at palpation at each follow-up visit
    - Lower Extremity Functional Scale (LEFS) score at each follow-up visit
    - Short Form 12 (SF-12) score at each follow-up visit
    - Sensitivity and specificity of RUST threshold value at 6 months predictive of bone healing with regard to fracture outcome

    Safety endpoints:
    - Any Adverse Event (AE)/Serious Adverse Event (SAE)
    - Adverse Event of Special Interest (AESI):
    o Suspected or confirmed acute or chronic infection related to the medical condition under evaluation
    o AEs possibly related to product failure
    o AEs suggesting infection related to implantation procedure
    o AEs suggesting hypersensitivity reaction
    o AEs suggesting ectopic bone formation
    Criterios de valoración de la eficacia

    Criterios secundarios clave de valoración de la eficacia:

    -Proporción de participantes que presentan éxito radiológico en la semana 16 (visita 5), la semana 20 (visita 6) y el mes 6 (visita 7)
    -Variación respecto al inicio en la puntuación de la escala RUST en la semana 12 (visita 4), la semana 16 (visita 5), la semana 20 (visita 6) y el mes 6 (visita 7)

    Otros criterios secundarios de valoración de la eficacia

    -Tiempo que transcurre hasta la consolidación de la fractura: según el criterio del investigador, la consolidación de la fractura se define como la capacidad de la tibia tratada para soportar la carga completa, la ausencia de dolor al realizar una palpación y la confirmación radiológica de la unión de la fractura. La confirmación radiológica de la unión de la fractura se define como la formación de puentes óseos en al menos tres de las cuatro cortezas y ausencia de la línea de fractura
    -Tiempo que transcurre hasta la consolidación clínica de la fractura: según el criterio del investigador con la condición de que la tibia tratada sea capaz de soportar la carga completa y no haya dolor a la palpación
    -Tiempo que transcurre hasta la consolidación radiológica de la fractura: realizada por radiólogos independientes con la condición de que exista confirmación radiológica de la unión de la fractura
    -Proporción de participantes que presentan consolidación de la fractura en cada visita de seguimiento

    -Proporción de participantes que presentan consolidación clínica de la fractura en cada visita de seguimiento
    -Proporción de participantes que presentan consolidación radiológica de la fractura en cada visita de seguimiento
    -Proporción de participantes con capacidad de soportar la carga completa en cada visita de seguimiento
    -Tiempo que transcurre hasta que se efectúa una intervención de rescate
    -Tiempo que transcurre hasta que se puede soportar la carga completa
    -Proporción de participantes que requieren una intervención de rescate en un plazo de 12 meses
    -Proporción de participantes diagnosticados de SA en el mes 9 (visita 8)
    -Proporción de participantes diagnosticados de RC en la semana 20 (visita 6)
    -Dolor al realizar una palpación en cada visita de seguimiento
    -Puntuación en la escala funcional de la extremidad inferior (Lower Extremity Functional Scale, LEFS) en cada visita de seguimiento
    -Puntuación en el cuestionario abreviado 12 (Short Form 12, SF-12) en cada visita de seguimiento
    -Sensibilidad y especificidad del valor umbral predictivo de consolidación de la fractura de la escala RUST a los 6 meses con respecto al desenlace de la fractura


    Criterios de valoración de la seguridad:

    -Cualquier acontecimiento adverso (AA) o acontecimiento adverso grave (AAG)
    -Acontecimiento adverso de interés especial (AAIE):
    Sospecha o confirmación de infección aguda o crónica relacionada con la dolencia en investigación
    AA posiblemente relacionados con la ineficacia del producto
    AA indicativos de infección relacionada con el procedimiento de implantación
    AA indicativos de reacción de hipersensibilidad
    AA indicativos de osificación ectópica
    E.5.2.1Timepoint(s) of evaluation of this end point
    6-12-16-20 weeks
    6-9-12 months
    6-12-16-20 semanas
    6-9-12 meses
    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 No
    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) No
    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 trial2
    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 EEA38
    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 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
    last visit last subject
    última visita del último paciente
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 178
    F.4.2.2In the whole clinical trial 178
    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)
    Study treatment will be administered once only. If the patient is in further need of treatment past study, the patient will receive treatment per local standard of care. Subjects treated with ALLOB® (discontinued or not) will also be followed up in an additional 5 years post-study safety follow-up (Separate Study Protocol).
    El tratamiento del estudio se administrará una sola vez. Si el paciente necesita más tratamiento una vez finalizado el estudio, lo recibirá de acuerdo con la práctica habitual del centro. Los pacientes tratados con ALLOB® (hayan interrumpido o no el tratamiento) también se someterán a seguimiento en un período adicional de seguimiento de la seguridad de 5 años de duración (protocolo de estudio diferente) una vez finalizado el estudio.
    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 Decision2020-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-06
    P. End of Trial
    P.End of Trial StatusOngoing
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