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    Summary
    EudraCT Number:2020-002443-38
    Sponsor's Protocol Code Number:C0371006
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-07
    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 number2020-002443-38
    A.3Full title of the trial
    Phase 3 open-label study to evaluate efficacy, safety, and tolerability of FIX gene transfer with fidanacogene elaparvovec (PF-06838435) in pediatric male participants <18 years of age with moderately severe to severe hemophilia B (FIX:C=2%) (BeneGene 3).
    Studio di Fase III, in aperto per valutare l'efficacia, la sicurezza e la tollerabilità del trasferimento genico FIX con fidanacogene
    elaparvovec (PF-06838435) in pazienti pediatrici maschi di età <18 anni con emofilia B da moderatamente severa a severa (FIX:C=2%) (BeneGene 3)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Pediatric Male Participants with moderately severe to severe Hemophilia B (BeneGene-3).
    Uno studio per valutare l'efficacia e la sicurezza della terapia genica con Fattore IX con PF-06838435 in partecipanti maschi pediatrici con Emofilia B da moderatamente grave a grave (BeneGene-3).
    A.3.2Name or abbreviated title of the trial where available
    BeneGene-3
    BeneGene-3
    A.4.1Sponsor's protocol code numberC0371006
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/222/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPFIZER INC
    B.1.3.4CountryUnited States
    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 supportPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2090
    D.3 Description of the IMP
    D.3.1Product namerAAV-Spark100-hFIX39-Padua
    D.3.2Product code [PF-06838435]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFIDANACOGENE ELAPARVOVEC
    D.3.9.2Current sponsor codePF-06838435
    D.3.9.4EV Substance CodeSUB193007
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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
    moderately severe to severe hemophilia B (FIX:C=2%)
    emofilia B da moderatamente severa a severa (FIX:C=2%)
    E.1.1.1Medical condition in easily understood language
    Hemophilia B, or Christmas disease, results from a deficiency of blood coagulation Factor IX (FIX).
    L'emofilia B, o malattia di Natale, è il risultato di una carenza del Fattore IX della coagulazione del sangue (FIX).
    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 10060614
    E.1.2Term Hemophilia B (Factor IX)
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate efficacy of a single infusion of PF-06838435 (fidanacogene elaparvovec) in male pediatric participants <18 years of age with moderately severe to severe hemophilia B (FIX:C=2%)
    Dimostrare l'efficacia di una singola infusione di PF-06838435 (fidanacogene elaparvovec) in partecipanti maschi pediatrici di età inferiore ai 18 anni con emofilia B da moderatamente grave a grave (FIX:C=2%)
    E.2.2Secondary objectives of the trial
    • To further evaluate efficacy of a single infusion of PF-06838435 (fidanacogene elaparvovec) in male pediatric participants <18 years of age with moderately severe to severe hemophilia B (FIX:C=2%)
    • Safety and tolerability of a single infusion of PF-06838435 (fidanacogene elaparvovec) in male pediatric participants <18 years of age with moderately severe to severe hemophilia B (FIX:C=2%)
    • Assess durability of efficacy up to 5 years
    - Valutare ulteriormente l'efficacia di una singola infusione di PF-06838435 in partecipanti pediatrici maschi <18 anni di età con emofilia B da moderatamente grave a grave (FIX:C=2%)
    - Sicurezza e tollerabilità di una singola infusione di PF-06838435 (fidanacogene elaparvovec) in partecipanti pediatrici maschi <18 anni con emofilia B da moderatamente grave a grave (FIX:C=2%)
    - Valutare la durata dell'efficacia nell'arco di massimo 5 anni
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Participant must be <18 years of age at the time of signing the informed consent/assent from Study Site.
    •For enrollment in Cohort 1, participant must be =12 to <18 years of age.
    •Criteria for Cohorts 2 and 3 will be provided at time of future protocol amendment.
    2.Participants who have laboratory-documented moderately severe to severe hemophilia B, defined as FIX:C=2%.
    3.For Cohort 1, participants who have been on stable routine prophylaxis for at least 1 year.
    4.For Cohort 1, participants who have at least 50 documented exposure days to FIX replacement product (recombinant, plasma-derived, or longacting FIX product).
    5.For Cohort 1, participants who have at least 1 year of diary information in which exogenous FIX replacement infusions and hemophilic bleeding episodes were documented in real time as they occurred over the previous 12 months.
    6.Participants/legally authorized representatives must agree to suspend prophylaxis therapy for hemophilia B after administration of the study intervention. FIX replacement therapy is allowed as needed.
    7.Participants who at screening have:
    •Hemoglobin above or equal to the lower limit of normal for age;
    •Platelets =100,000 cells/µL;
    •Creatinine =1.5 × ULN for age.
    8. Male
    Sexually active participants must agree to use contraception in accordance with time period specified in the protocol.
    1. Il partecipante deve avere un'età inferiore a 18 anni al momento della firma del consenso/assenso informato presso il centro di studio.
    • Per l'iscrizione alla coorte 1, il partecipante deve avere un'età compresa tra =12 e <18 anni
    • I criteri per le coorti 2 e 3 saranno forniti al momento della futura modifica del protocollo.
    2. Partecipanti con emofilia B da moderatamente grave a grave documentata da test di laboratorio, definita come FIX:C=2%
    3. Per la coorte 1 i partecipanti che sono stati sottoposti a una profilassi di routine stabile per almeno 1 anno
    4. Per la coorte 1 i partecipanti con almeno 50 giorni di esposizione al prodotto sostitutivo FIX documentati (prodotto FIX ricombinante, derivato dal plasma o a lunga durata d'azione).
    5. Per la coorte 1 i partecipanti che hanno almeno 1 anno di informazioni registrate nel diario e in cui sono state documentate in tempo reale le infusioni sostitutive esogene di FIX e gli episodi di sanguinamento emofiliaco verificatisi nei 12 mesi.
    6. I partecipanti/rappresentanti legalmente autorizzati devono dare il loro consenso a interrompere la terapia profilattica per l'emofilia B dopo la somministrazione del prodotto oggetto di studio.
    7. I partecipanti che allo screening hanno:
    • Emoglobina superiore o uguale al limite inferiore per l'età;
    • Piastrine =100.000 cellule/µl;
    • Creatinina =1,5 × ULN per l'età
    8. Maschio
    I partecipanti sessualmente attivi devono accettare di utilizzare la contraccezione in conformità con il periodo di tempo specificato nel protocollo.
    E.4Principal exclusion criteria
    1.Anti-AAV-Spark100 nAb titer =1:1 (i.e., positive for nAb), at screening.
    2.Participants who have current or prior history of inhibitor to FIX.
    3.Known hypersensitivity to FIX replacement product or IV immunoglobulin administration.
    4.History of thrombotic events including, but not limited to, stroke or myocardial infarction.
    5.History of or any concurrent clinically significant major chronic disease, infection, or condition that the investigator deems unsuitable for participation.
    6.ALT, AST, alkaline phosphatase >2 × ULN.
    7.Bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    8.Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, hepatic encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
    9.Currently on antiviral therapy for hepatitis B or C.
    10.Any participant with a planned surgical procedure requiring FIX surgical prophylactic factor treatment in the next 12 months.
    11.Participant received any vaccination(s) in the 3 months prior to infusion of study intervention with the exception of nonlive influenza vaccination, which is permissible up to 1 month prior to infusion of study intervention.
    12.Previously dosed in a gene therapy research trial at any time or in an interventional clinical study within the last 12 weeks.
    13.Active hepatitis B or C; hepatitis B surface antigen positivity, hepatitis B core antibody positivity, hepatitis B virus-DNA positivity, or hepatitis C virus-RNA viral load positivity, respectively.
    14.Significant liver disease, as defined by pre-existing diagnosis of portal hypertension, splenomegaly, or hepatic encephalopathy or a serum albumin level below normal limits during screening. Significant fibrosis will be screened for in all participants with testing by FibroTest/FibroSURE (a score of >0.48 is exclusionary), FibroScan (a score of >8 kPa is exclusionary), or shear wave elastography by conventional ultrasound (a score of >6.7 kPa is exclusionary).
    15.Serological evidence of HIV-1 or HIV-2 with CD4+ cell count = 200/mm3 or viral load >20 copies/mL.
    16.Sensitivity to heparin or heparin-induced thrombocytopenia.
    17.Sensitivity to the study intervention, or components thereof, or drug or other allergy that, in the opinion of the investigator or the sponsor's. Medical Monitor, contraindicates participation in the study.
    1. Titolo anticorpale NAb anti-AAV-Spark100 =1:1 (ovvero con NAb positivo), durante lo screening.
    2. Partecipanti che hanno un'anamnesi attuale o passata di inibitori del FIX.
    3. Nota ipersensibilità al prodotto sostitutivo del FIX o alla somministrazione di immunoglobuline per via endovenosa.
    4. Anamnesi di eventi trombotici, inclusi ma non limitati a ictus o infarto del miocardio.
    5. Anamnesi o qualsiasi altra malattia, infezione o disturbo cronico grave clinicamente rilevante, o condizione che lo sperimentatore ritenga non adatta per la partecipazione
    6. ALT, AST, fosfatasi alcalina >2 × ULN
    7. Bilirubina >1,5 × ULN (la bilirubina isolata >1,5 × ULN è accettabile se la bilirubina è frazionata e la bilirubina diretta <35%)
    8. Malattia epatica corrente instabile o patologia biliare, in base alla valutazione dello sperimentatore, stabilita dalla presenza di ascite, encefalopatia epatica, coagulopatia, ipoalbuminemia, varici esofagee o gastriche, itterizia persistente o cirrosi.
    9. Assunzione attuale di una terapia antivirale per l’epatite B o C.
    10. Qualsiasi partecipante per cui sia già stato programmato un intervento chirurgico che richieda il trattamento con fattore profilattico chirurgico FIX nei 12 mesi successivi.
    11. Il partecipante ha ricevuto qualsiasi vaccinazione nei 3 mesi precedenti l'infusione del prodotto oggetto di studio, ad eccezione della vaccinazione antinfluenzale con virus non vivo, che è consentita fino a 1 mese prima dell'infusione del prodotto oggetto di studio
    12. Precedente partecipazione con somministrazione in un trial clinico sulla terapia genica in qualsiasi momento, o a uno studio clinico interventistico nelle ultime 12 settimane.
    13. Epatite B o C attive; positività all'antigene di superficie dell'epatite B, positività all'antigene core dell'epatite B, positività all'anticorpo del virus dell'epatite B, positività al virus-DNA dell'epatite B o positività alla carica virale del virus-RNA dell'epatite C.
    14. Patologia epatica significativa, come definita dalla diagnosi preesistente di ipertensione portale, splenomegalia, o encefalopatia epatica o un livello di albumina nel siero inferiore ai limiti normali durante lo screening. La fibrosi significativa sarà verificata in tutti i partecipanti tramite test FibroTest/FibroSURE (un punteggio di >0,48 è motivo di esclusione), FibroScan (un punteggio di >8 kPa è motivo di esclusione), o elastografia shear wave a ultrasuoni convenzionali (un punteggio di >6,7 kPa è motivo di esclusione).
    15. Evidenza sierologica di HIV-1 o HIV-2 con conta delle cellule CD4+ =200/mm3 o carica virale >20 copie/mL.
    16. Sensibilità all'eparina o trombocitopenia indotta da eparina.
    17. Sensibilità ai prodotti oggetto dello studio o a loro componenti oppure a un farmaco o un'altra allergia che, secondo il parere dello sperimentatore o del monitor medico dello sponsor, renda controindicata la partecipazione allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    •ABR for the first year post-PF-06838435 infusion versus ABR for prophylaxis FIX replacement regimen (retrospectively collected during the 1 year immediately prior to informed consent).
    •Steady-state vector-derived FIX:C level (from Week 12 to 1 year).
    • Tasso di sanguinamento annuale (ABR) nel primo anno dopo l'infusione di PF- 06838435 e tasso di sanguinamento annuale (ABR) nel regime di sostituzione della profilassi FIX (raccolto retrospettivamente durante il primo anno immediatamente prima del consenso informato).
    • Livello di FIX:C derivante dal vettore in stato stazionario (dalla Settimana 12 a 1 anno).
    E.5.1.1Timepoint(s) of evaluation of this end point
    from Week 12 to 1 year
    da 12 settimane a un anno
    E.5.2Secondary end point(s)
    •AIR for the first year post-infusion
    Additional Secondary Endpoints:
    •Annualized dose and total factor consumption during the first year post infusion
    •Percentage of participants without bleeds during the first year postinfusion
    •Change from baseline in joint health as measured by the HJHS instrument at 1 year post-infusion
    •Change from baseline in quality of life measured by: Haem-AQoL/ Haemo-QoL Physical Health domain score at 1-year post-infusion, if age cohort appropriate
    •Change from baseline in activity level measured by pedHAL Function of the Legs domain score at 1-year post infusion, if age cohort appropriate
    •Incidence and severity of adverse events collected during the study
    • Tasso di infusione annualizzato (AIR) nel primo anno dopo l'infusione
    Ulteriori endpoint secondari:
    • Dose annualizzata e consumo totale dei fattori nel primo anno dopo l'infusione
    • Percentuale di partecipanti che non hanno manifestato episodi di sanguinamento nel primo anno dopo l'infusione
    • Variazione rispetto al basale della salute delle articolazioni misurata dallo strumento HJHS a 1 anno dopo l'infusione
    • Variazione rispetto al basale della qualità della vita misurata in base a: punteggio del dominio della salute fisica Haem-AQoL/ Haemo-QoL a 1 anno dopo l'infusione, se l'età della coorte è appropriata
    • Variazione rispetto al basale del livello di attività misurato con il punteggio di Funzionalità delle gambe pedHAL a 1 anno dopo l'infusione, se l'età della coorte è appropriata
    • Incidenza e gravità degli eventi avversi manifestatisi nel corso dello studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    first year post infusion
    primo anno dopo l'infusione
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    immunogenicità
    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 No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Japan
    Korea, Republic of
    France
    Germany
    Italy
    Spain
    Sweden
    United Kingdom
    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 years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 11
    F.4.2.2In the whole clinical trial 15
    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)
    no difference from the expected normal treatment of that condition
    nessuna differenza dal normale trattamento previsto per quella condizione
    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 Decision2021-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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