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    Summary
    EudraCT Number:2015-004717-25
    Sponsor's Protocol Code Number:Low-PV
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-004717-25
    A.3Full title of the trial
    The benefit/risk profile of pegylated proline-Interferon alpha-2b (AOP2014) added to the best available strategy based on phlebotomies in low-risk patients with Polycythemia Vera (PV). The Low-PV randomized trial.
    Il profilo beneficio/rischio della Prolina-interferone alfa-2b peghilato (AOP2014), in aggiunta alla migliore strategia terapeutica disponibile basata sui salassi, in pazienti con Policitemia Vera (PV) a basso rischio. Lo studio randomizzato Low-PV.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the effects of pegylated-proline-Interferon-alpha-2b (AOP2014) added to the best available therapy based on phlebotomies in low-risk patients with Polycythemia Vera (PV), who are younger than 60 and who have never experienced thrombosis.
    Valutazione degli effetti dell’aggiunta del farmaco Prolina-interferone alfa-2b peghilato (AOP2014) alla migliore cura disponibile e usata basata sui salassi, nei malati di Policitemia Vera (PV) a basso rischio, cioè con età inferiore a 60 anni e che non hanno mai avuto episodi di trombosi.
    A.3.2Name or abbreviated title of the trial where available
    Low-PV
    Low-PV
    A.4.1Sponsor's protocol code numberLow-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 SponsorFONDAZIONE PER LA RICERCA OSPEDALE MAGGIORE DI BERGAMO - FROM
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationFondazione per la ricerca Ospedale Maggiore (FROM)
    B.5.2Functional name of contact pointUfficio Sperimentazioni FROM
    B.5.3 Address:
    B.5.3.1Street AddressPiazza OMS, 1
    B.5.3.2Town/ cityBergamo (BG)
    B.5.3.3Post code24127
    B.5.3.4CountryItaly
    B.5.4Telephone number+39(0)352673678
    B.5.5Fax number+ 39(0)352674926
    B.5.6E-mailsperimentazioni.from@asst-pg23.it
    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 IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNropeginterferon alfa-2b
    D.3.9.1CAS number 1335098-50-4
    D.3.9.2Current sponsor codeAOP2014
    D.3.9.3Other descriptive namePEG-Proline-IFN α-2b; P1101
    D.3.9.4EV Substance CodeSUB12549MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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, that is a disease characterized by an uncontrolled proliferation of blood, that increase (red cells, white cells and platelets).
    Policitemia vera, una malattia caratterizzata dalla proliferazione incontrollata delle cellule del sangue, che aumentano (globuli rossi, globuli bianchi e piastrine).
    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 20.0
    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 whether the addition of Pegylated Proline-interferon alpha-2b to the best therapeutic current strategy available based on phlebotomies and low dose acetylsalicilic acid (ASA) could improve the efficacy of treatment of patients with PV at low risk in term of control of recommended level of hematocrit < 45%, over a period of 12 months.
    Valutare se l’aggiunta della Prolina-interferone alfa-2b peghilato alla strategia terapeutica basata sui salassi può migliorare l’efficacia del trattamento dei pazienti con PV a basso rischio, in termini di controllo dell’ematocrito (HCT) ai livelli raccomandati < 45%, valutato lungo il periodo di 12 mesi.
    E.2.2Secondary objectives of the trial
    Comparative evaluation of:
    • Reduction of the need of phlebotomies
    • Hematological response
    • Thrombotic and hemorrhagic events
    • Proportion of patients with not palpable spleen
    • Bone marrow histological remission
    • Molecular response
    • Quality of life of patients
    • Rate of assigned treatment withdrawal due to any protocol drug-related toxicity
    • Adverse events rate
    Valutazione comparata tra i due bracci di:
    • Riduzione del bisogno dei salassi
    • Risposta ematologica
    • Risposta molecolare
    • Eventi trombotici ed emorragici
    • Proporzione dei pazienti con milza non palpabile Remissione istologica del midollo osseo
    • Qualità di vita dei pazienti
    • Tasso di interruzioni della terapia assegnata, dovute a qualsiasi tossicità relativa al trattamento in corso da protocollo
    • Tasso di eventi avversi
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Molecular study within the Low-PV trial (Version 2.1, 15/02/2016): the explorative objective is to determine the efficacy of treatment on the JAK2V617F allele burden.
    Studio molecolare del trial Low-PV (Versione 2.1, 15/02/2016): l'obiettivo esplorativo è quello di determinare l'efficacia della terapia sull'espressione allelica di JAK2V617F.
    E.3Principal inclusion criteria
    1. Age 18-60 years
    2. Diagnosis of Polycythemia Vera according to WHO 2008 criteria
    3. Diagnosis of Polycythemia Vera performed within 3 years prior inclusion in the study and never treated with cytoreductive drugs
    4. HCT<45%
    5. Ability and willingness to comply with all study requirements
    6. Signed written informed consent
    1. Età di 18-60 anni
    2. Diagnosi di Policitemia Vera in accordo con i criteri WHO 2008
    3. Diagnosi di Policitemia Vera entro i 3 anni che precedono l’inclusione in studio e che non abbiano mai ricevuto farmaci citoriduttivi in precedenza
    4. HCT<45%
    5. Abilità e buona volontà di accettare tutte le richieste necessarie per la conduzione dello studio
    6. Firma del consenso informato scritto
    E.4Principal exclusion criteria
    1. Any previous well documented cardiovascular PV-related events (see Appendix 1 for description)
    2. Previous cytoreductive drugs
    3. Known hypersensitivity or contraindications to the IMP (Pegylated Proline-Interferon alpha-2b)
    4. Previous exposure to a non-pegylated or pegylated interferon α
    5. Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis
    6. Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
    7. Significant liver (AST or ALT > 2.5 times ULN) or renal disease (creatinine > 2 mg/ml)
    8. Presence of any life-threatening condition or of any disease (e.g. cancer) that is likely to significantly shorten life expectancy
    9. History of active substance or alcohol abuse within the last year
    10. Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol
    11. Pregnant or lactating women and women*/men of childbearing potential who are not using or are not willing to use any effective means of contraception
    1. Qualsiasi evento cardiovascolare documentato correlato alla PV (vedi Appendice 1 per descrizione)
    2. Somministrazione precedente di farmaci citoriduttivi.
    3. Ipersensibilità o controindicazioni note al farmaco in sperimentazione (IMP) Prolina-interferone alfa-2b peghilato
    4. Esposizione precedente all’ interferone peghilato o non peghilato
    5. Infiltrati polmonari di rilevanza clinica e polmonite
    6. Infezioni sistemiche, e.g. epatite B, epatite C, o HIV allo screening
    7. Disturbi epatici (AST or ALT > 2.5 volte ULN) o renali (creatinina > 2 mg/ml) significativi
    8. Presenza di condizioni potenzialmente mortali o di altri disturbi (e.g. cancro) che facciano prevedere una breve sopravvivenza.
    9. Storie di abuso di alcol o di droghe nell’ultimo anno
    10. Ogni condizione che nell’opinione dello sperimentatore metterebbe in pericolo la valutazione di efficacia e sicurezza o potrebbe essere associata a una insufficiente aderenza al protocollo
    11. Donne in gravidanza o in allattamento oppure donne*/uomini che non adottino o non vogliono adottare metodi efficaci di contraccezione
    E.5 End points
    E.5.1Primary end point(s)
    Proportion (%) of responders to assigned treatment strategy defined as patients who maintain the median HCT values <45% during 12 months after treatment in each arm, without progression of disease and no need of any extra-protocol cytoreductive drugs.
    Proporzione (%) dei pazienti che rispondono alla strategia di trattamento assegnato, definiti come quelli che mantengono la mediana dei valori di HCT <45% durante i 12 mesi dopo la randomizzazione, in ciascun braccio di trattamento, senza progressione di malattia e bisogno di ulteriori farmaci citoriduttivi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 montns
    12 mesi
    E.5.2Secondary end point(s)
    Quality of Life (QoL):
    • Functional Assessment of Cancer Therapy-Anemia (FACT-An)
    • Myeloproliferative Neoplasm Symptoms Assessment Form total symptom score (MPN-SAF TSS/MPN10)
    Qualità della vita (QoL):
    • Valutazione funzionale dell’anemia legata al trattamento del cancro (FACT-An)
    • Questionario per la valutazione dei sintomi nelle malattie mieloproliferative croniche- 10 (MPN-10)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline (before starting the protocol therapy), every 3 months until the end of the study and at the completion of the study.
    Al basale (prima di iniziare la terapia da protocollo), ogni 3 mesi fino alla fine dello studio e al suo completamento.
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Lo studio prevede 2 fasi: 1) studio core; 2) fase di estensione.
    The study includes 2 phase: 1)core study; 2) extension phase.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Regime standard raccomandato basato sui salassi e acido acetilsalicilico a basso dosaggio (100mg).
    Standard recommended therapy based on phlebotomies and low dose of acetylsalicylic acid (100mg).
    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 concerned22
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned 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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    Patients will be treated with the best recommended available therapy according to their clinical condition.
    I pazienti verranno trattati con la migliore terapia disponibile raccomandata per la loro condizione clinica.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation AIRC – Gruppo Italiano Malattie Mieloproliferative (AGIMM)
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
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