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    Summary
    EudraCT Number:2014-001357-17
    Sponsor's Protocol Code Number:CONTINUATION-PV
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-16
    Trial results View 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 number2014-001357-17
    A.3Full title of the trial
    An open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of AOP2014 in patients with Polycythemia Vera who previously participated in the PROUD-PV study
    Ensayo en fase IIIb, abierto y multicéntrico, que evalúa la eficacia a largo plazo y la seguridad de AOP2014 en pacientes con policitemia vera que han participado previamente en el estudio PROUD-PV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of AOP2014 in patients with Polycythemia Vera who previously participated in the PROUD-PV study
    Ensayo en fase IIIb, abierto y multicéntrico, que evalúa la eficacia a largo plazo y la seguridad de AOP2014 en pacientes con policitemia vera que han participado previamente en el estudio PROUD-PV
    A.3.2Name or abbreviated title of the trial where available
    CONTINUATION-PV
    CONTINUATION-PV
    A.4.1Sponsor's protocol code numberCONTINUATION-PV
    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 SponsorAOP Orphan Pharmaceuticals AG
    B.1.3.4CountryAustria
    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 supportAOP Orphan Pharmaceuticals AG
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL DEL MAR
    B.5.2Functional name of contact pointCarles Besses Raebel
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Marítim de la Barceloneta, 25
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08003
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932483341
    B.5.5Fax number+34932483343
    B.5.6E-mailcbesses@parcdesalutmar.cat
    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/3/11/932
    D.3 Description of the IMP
    D.3.1Product namePegylated proline-interferon alpha-2b
    D.3.2Product code AOP2014
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGylated Proline-interferon alpha-2b recombinant
    D.3.9.1CAS number 1335098-50-4
    D.3.9.2Current sponsor codePEG-P-INFa-2b; P1101
    D.3.9.3Other descriptive namePEGINTERFERON ALFA-2B
    D.3.9.4EV Substance CodeSUB12549MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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
    Polycythemia Vera
    Policitemia vera
    E.1.1.1Medical condition in easily understood language
    Polycythemia Vera, a myeloproliferative disease of blood forming cells
    La policitemia vera es un trastorno mieloproliferativo de las células que forman la sangre
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10036061
    E.1.2Term Polycythemia vera
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term efficacy of AOP2014 in terms of disease response rate in patients diagnosed with PV, who were previously treated with AOP2014 in the PROUD-PV study and who completed this study.
    Evaluar la eficacia a largo plazo de AOP2014 en lo que respecta a la tasa de respuesta de la enfermedad en pacientes a los que se ha diagnosticado PV, que han recibido tratamiento previo con AOP2014 en el estudio PROUD-PV y que han completado este estudio.
    E.2.2Secondary objectives of the trial
    To further assess the long-term efficacy, safety, quality of life (QoL) and change of JAK2 allelic burden in patients diagnosed with PV and previously treated with AOP2014 in the PROUD-PV study.
    Evaluar en mayor profundidad la eficacia a largo plazo, la seguridad, la calidad de vida (CdV) y el cambio en la carga alélica de JAK-2 en pacientes a los que se ha diagnosticado PV y que han recibido tratamiento previo con AOP2014 en el estudio PROUD-PV.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1/ optional geneting testing
    2/ optional bone marrow samplings (one at screening prior the first study drug dose, and another one after completion of the 12 month period) taken and sent for central evaluation will be setup within the PROUD-PV study. Patients may decline participation in the bone marrow sub study, while remaining on the main study protocol.
    1/ Test genético opcional.
    2/ Dentro del estudio CONTINUATION-PV se puede realizar una toma opcional de muestras de médula ósea (una en la selección, antes de la primera dosis del fármaco del estudio, y otra después de la finalización del período de 12 meses) que se envía para su evaluación centralizada. Los pacientes pueden rechazar su participación en el subestudio de médula ósea, manteniendo su participación en el protocolo del estudio principal.
    E.3Principal inclusion criteria
    1. Patients who completed the 12 months AOP2014 treatment arm of the PROUD-PV study and at the "end-of-treatment visit" (EoT) of the PROUD-PV study who fulfill at least one of the following criteria:
    a. normalization of at least two out of three main blood parameters (Hct, PLTs and WBCs) if these parameters were moderately increased (Hct<50%, WBC<20 x 10(9)/L, PLTs<600 x 10(9)/L) at baseline of the PROUD-PV study, OR
    b. >35% decrease of at least two out of three main blood parameters (Hct, PLTs and WBCs) if these parameters were massively increased (Hct>50%, WBCs>20 x 10(9)/L, PLTs>600 x 10(9)/L), at baseline of the PROUD-PV study, OR
    c. normalization of spleen size, if spleen was enlarged at baseline of the PROUD-PV study, OR
    d. otherwise a clear, medically verified benefit from treatment with AOP2014 (e.g. normalization of disease-related micro-vasculatory symptoms, substantial decrease of JAK2 allelic burden).
    2. Signed written ICF.
    1. Pacientes que completaron el grupo de tratamiento con AOP2014 de 12 meses del estudio PROUD-PV y en la “visita de fin de tratamiento” (EoT) del estudio PROUD-PV cumplían al menos uno de los, siguientes criterios:
    a. Normalización de al menos dos de tres parámetros sanguíneos principales (Hto, Pl y LEU) en el caso de que dichos parámetros hubiesen aumentado de forma moderada (Hto<50 %, LEU< 20 x 109/L, Pl<600 x 109/L) en la visita basal del estudio PROUD-PV, O
    b. >35 % de descenso de al menos dos de tres parámetros sanguíneos principales (Hto, Pl y LEU) si estos parámetros hubiesen aumentado de forma masiva (Hto>50 %, LEU >20 x 109/L, Pl>600 x 109/L), en la visita basal del estudio PROUD-PV, O
    c. Normalización del tamaño del bazo, si este hubiese aumentado su tamaño en la visita basal del estudio PROUD-PV, O
    d. cualquier otro beneficio claro y médicamente contrastado del tratamiento con AOP2014 (por ej. normalización de los síntomas microvasculares asociados a la enfermedad, reducción sustancial de la carga alélica de JAK2).
    2. HCI por escrito firmado.
    E.4Principal exclusion criteria
    1. Non-recovery from the AOP2014 related toxicities to the grade (usually, Grade I) which allows continuation of the treatment.
    2. HADS score of 11 or higher on either or both of the subscales, and /or development or worsening of the clinically significant depression or suicidal thoughts.
    3. Progressive and clinically significant increase of liver enzyme levels despite dose reduction, or if such increase is accompanied by increased bilirubin level, any signs or symptoms of a clinically significant autoimmune disease.
    4. Clinically significant development of a new ophthalmologic disorder, or worsening of a pre-existing one, during the study.
    5. Loss of efficacy of AOP2014 or any comparable situation where no further benefits of treatment continuation are expected by the investigator.
    1. No recuperación de las toxicidades relacionadas con AOP2014 hasta el grado (habitualmente Grado I) que permite la continuación del tratamiento.
    2. Puntuación HADS de 11 o superior en una de las subescalas o en ambas y/o presencia o empeoramiento de depresión o pensamientos suicidas médicamente significativos.
    3. Aumento progresivo y médicamente significativo de los niveles de enzimas hepáticas a pesar de la reducción de dosis, o si dicho aumento viene acompañado por un aumento del nivel de bilirrubina, signos o síntomas de una enfermedad autoinmune médicamente importante.
    4. Presencia médicamente importante de una nueva enfermedad oftalmológica, o empeoramiento de una preexistente durante el estudio.
    5. Pérdida de la eficacia de AOP2014 o cualquier situación comparable en la que el investigador no espera más beneficios de la continuación del tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    The main efficacy evaluation criterion will be disease response defined as Hct<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs<400 x 109/L, WBCs<10 x 109/L, and normal spleen size.
    The main efficacy endpoint will be the maintenance rate of disease response at assessment visits (every three months).
    El criterio de evaluación de la eficacia principal será la respuesta de la enfermedad definida como un nivel de Hto < 45 % sin flebotomía (al menos 3 meses desde la última flebotomía), Pl < 400 x 109/l, LEU < 10 x 109/l y tamaño normal del bazo.
    El criterio de valoración principal de la eficacia será la tasa de mantenimiento de la respuesta de la enfermedad en las visitas de evaluación (cada tres meses)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every three months.
    Cada tres meses.
    E.5.2Secondary end point(s)
    1. Change in hematological parameters, Hct, WBCs, PLTs and erythrocytes (RBCs), from baseline (i.e. "EoT visit" in the PROUD-PV study) over time up to last patient visit.
    2. Change in spleen size from baseline (i.e. "EoT visit" in the PROUD-PV study) over time up to last patient visit.
    3. Duration of response maintenance.
    4. Phlebotomy need.
    5. Change in QoL (EQ-5D-3L) from baseline ("EoT visit" of the PROUD-PV study) over time up to last patient visit.
    6. Change in JAK2 allelic burden and other molecular and genetic abnormalities from baseline ("EoT visit" of the PROUD-PV study) over time up to last patient visit.
    Safety evaluation
    7. Incidence, causality and intensity of AEs according to common terminology criteria for adverse events (CTCAE 4.0).
    8. Events leading to dose reduction or permanent treatment discontinuation.
    9. Adverse events of special interest (AESI).
    10. Disease-related symptoms (microvascular disturbances, pruritus, headache).
    Criterios secundarios de valoración de la eficacia
    1. Variación en los parámetros hematológicos, Hto, LEU, Pl y eritrocitos (GR), desde la visita basal (es decir, la “visita EoT” del estudio PROUD-PV) a lo largo de tiempo hasta la última visita del paciente.
    2. Variación en el tamaño del bazo desde la visita basal (es decir, la “visita EoT” del estudio PROUD-PV) a lo largo del tiempo hasta la última visita del paciente.
    3. Duración del mantenimiento de la respuesta.
    4. Necesidad de flebotomía.
    5. Variación de la CdV (EQ-5D-3L) desde la visita basal (la “visita EoT” del estudio PROUD-PV) a lo largo del tiempo hasta la última visita del paciente.
    6. Variación en la carga alélica de JAK2 y otras anomalías genéticas y moleculares desde la visita basal (la “visita de EoT” del estudio PROUD-PV) a lo largo del tiempo hasta la última visita del paciente.
    Evaluación de la seguridad
    7. Incidencia, causalidad e intensidad de los AA según los Common Terminology Criteria for Adverse Events (CTCAE 4.0, criterios terminológicos comunes para acontecimientos adversos).
    8. Acontecimientos que provoquen una reducción de la dosis o la suspensión definitiva del tratamiento
    9. Acontecimientos adversos de especial interés (AAEI)
    10. Síntomas relacionados con la enfermedad (molestias microvasculares, prurito, cefalea)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every three months
    Cada tres 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 Yes
    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 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) 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Austria
    Bulgaria
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Poland
    Romania
    Russian Federation
    Slovakia
    Spain
    Ukraine
    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
    Study participation will be as long as the treatment is effective and tolerable/safe and until AOP2014 becomes otherwise available.
    La participación de los pacientes en el estudio continuará mientras el tratamiento sea eficaz y seguro/tolerable y hasta que se comercialice AOP2014 o se encuentre disponible de otra manera.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 130
    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 participation will be as long as the treatment is effective and tolerable/safe and until AOP2014 becomes otherwise available.
    La participación de los pacientes en el estudio continuará mientras el tratamiento sea eficaz y seguro/tolerable y hasta que se comercialice AOP2014 o se encuentre disponible de otra manera.
    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 Decision2015-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-29
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