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    Summary
    EudraCT Number:2019-004451-37
    Sponsor's Protocol Code Number:C3731003
    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:2021-05-24
    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 number2019-004451-37
    A.3Full title of the trial
    Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants with Moderately Severe to Severe Hemophilia A (FVIII:C=1%)
    Studio di fase 3, in aperto, a braccio singolo per valutare l’efficacia e la sicurezza di PF-07055480 (terapia genica con fattore umano VIII AAV2/6 ricombinante) in partecipanti maschi adulti affetti da emofilia A (FVIII:C=1%) da moderatamente grave a grave
    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 VIII Gene Therapy With PF-07055480 in Adult Males With Moderately Severe to Severe Hemophilia A
    Uno studio per valutare l'efficacia e la sicurezza della terapia genica con fattore VIII con PF-07055480 in maschi adulti con emofilia A da moderatamente grave a grave
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberC3731003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04370054
    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 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 codeNY 10017
    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/3/17/1874
    D.3 Description of the IMP
    D.3.1Product namegiroctocogene fitelparvovec
    D.3.2Product code [PF-07055480]
    D.3.4Pharmaceutical form Solution for injection/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 INNgiroctocogene fitelparvovec
    D.3.9.2Current sponsor codePF-07055480
    D.3.9.4EV Substance CodeSUB203742
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Hemophilia A
    Emofilia A
    E.1.1.1Medical condition in easily understood language
    Inherited condition caused by a lack of Factor VIII which is required for blood to clot and stop any bleeding
    Condizione ereditaria causata dalla mancanza del Fattore VIII necessario per la coagulazione del sangue e per fermare qualsiasi sanguinamento
    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 10060613
    E.1.2Term Hemophilia A (Factor VIII)
    E.1.2System Organ Class 100000004850
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10060613
    E.1.2Term Hemophilia A (Factor VIII)
    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
    Evaluate the efficacy of a single infusion of PF-07055480 in participants =18 and <65 years of age with moderately severe to severe hemophilia A (FVIII C = 1%).
    Valutare l’efficacia di una singola infusione di PF-07055480 nei partecipanti di età =18 e <65 anni con emofilia A da moderatamente grave a grave (FVIII:C=1%).
    E.2.2Secondary objectives of the trial
    - To demonstrate that the use of exogenous Factor VIII (FVIII) is significantly reduced post PF-07055480 infusion.
    - To compare additional efficacy parameters post PF-07055480 infusion including use of exogenous FVIII, information on bleeding events and patient-reported outcomes (PROs).
    - Estimate the durability of efficacy up to 5 years after PF-07055480 infusion.
    - To estimate the safety and tolerability of PF-07055480, including immunogenicity, for the study duration of 5 years after PF-07055480 infusion.
    - Dimostrare che l’uso di FVIII esogeno si riduce notevolmente dopo l’infusione di PF- 07055480.
    - Confrontare ulteriori parametri di efficacia dopo l’infusione di PF-07055480, compreso l’uso di FVIII esogeno, informazioni su episodi di sanguinamento e PRO.
    - Stimare la durata dell’efficacia fino a 5 anni dopo l’infusione di PF- 07055480.
    - Stimare la sicurezza e la tollerabilità di PF- 07055480, compresa l’eventuale immunogenicità, nel corso dei 5 anni dello studio dopo l’infusione di PF-07055480.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: - Optional vector shedding sub-study, 10 Dec 2019, Version 1: To further characterize the kinetics of vector shedding.
    - Optional ultrasounds of the joints sub-study, 10 Dec 2019, Version 1: To compare and evaluate joint health post PF-07055480 infusion to baseline via ultrasounds.
    - Optional X-rays of the joints sub-study, 11 Aug 2020, Version 1: To compare joint health post PF-07055480 infusion to baseline and evaluate long-term joint outcomes via X-rays.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: - Sottostudio opzionale di disseminazione del vettore, 10 dicembre, versione 1: al fine di caratterizzare ulteriormente la cinetica della diffusione dei vettori.
    - Sottostudio opzionale di ultrasuoni delle articolazioni, 10 dicembre 2019, versione 1: al fine di confrontare e valutare lo status delle articolazioni dopo l'infusione PF-07055480 rispetto al basale tramite ultrasuoni.
    - Sottostudio opzionale di raggi X delle articolazioni, 11 agosto 2020, versione 1: al fine di confrontare lo status delle articolazioni a seguito dell'infusione PF-07055480 rispetto al basale e valutare gli esiti sulle articolazioni a lungo termine tramite raggi X.
    E.3Principal inclusion criteria
    • Males who completed 6 months of routine Factor VIII prophylaxis therapy during the lead in study(C0371004) and have = 150 documented exposure days to a Factor VIII protein product
    • Moderately severe to severe hemophilia A (Factor VIII activity = 1%)
    • Suspension of FVIII prophylaxis therapy post study drug infusion

    For full list of inclusion criteria please refer to study protocol.
    • Uomini che hanno completato 6 mesi di terapia profilattica di routine del fattore VIII durante la fase iniziale dello studio (C0371004) e hanno = 150 giorni di esposizione documentata a un prodotto proteico del fattore VIII
    • Emofilia A da moderatamente grave a grave (attività del fattore VIII = 1%)
    • Sospensione della terapia profilattica del fattore VIII dopo l'infusione del farmaco in studio

    Per l'elenco completo dei criteri di esclusione si prega di fare riferimento al protocollo di studio.
    E.4Principal exclusion criteria
    • Anti-AAV6 neutralizing antibodies
    • History of inhibitor to Factor VIII
    • Laboratory values at screening visit that are abnormal or outside acceptable study limits
    • Significant and/or unstable liver disease, biliary disease, significant liver fibrosis
    • Planned surgical procedure requiring Factor VIII surgical prophylactic factor treatment 12 months from screening visit
    • Active hepatitis B or C
    •Serological evidence of human immunodeficiency virus HIV-1 or HIV-2 with Cluster of Differentiation 4 positive (CD4+) cell count =200 mm3 and/or viral load >20 copies/mL

    For full list of exclusion criteria please refer to study protocol.
    • Anticorpi neutralizzanti anti-AAV6
    • Anamnesi pregressa di inibitore del FVIIII
    • Valori di laboratorio alla visita di screening che sono anormali o fuori dai limiti accettabili dello studio
    • Malattia epatica significativa e / o instabile, patologia biliare, fibrosi epatica significativa
    • Procedura chirurgica pianificata che richiede un trattamento profilattico chirurgico con fattore VIII 12 mesi dalla visita di screening
    • Epatite B o C attiva
    • Evidenza sierologica del virus dell'immunodeficienza umana HIV-1 o HIV-2 con conta delle cellule CD4+ =200 mm3 e / o carica virale> 20 copie / mL

    Per l'elenco completo dei criteri di esclusione si prega di fare riferimento al protocollo di studio.
    E.5 End points
    E.5.1Primary end point(s)
    Annualized bleeding rate (ABR, spontaneous and traumatic bleedings) through 12 months following PF-07055480 infusion (from Week 3) versus ABR on prior Factor VIII (FVIII) prophylaxis replacement regimen.
    ABR (sanguinamenti spontanei e traumatici) fino a 12 mesi dopo l’infusione di PF-07055480 (dalla Settimana 3) rispetto ad ABR con la terapia profilattica sostitutiva con FVIII precedente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Week 3 to 12 months (primary analysis) post study drug infusion
    Dalla settimana 3 a 12 mesi (analisi primaria) dopo l'infusione del farmaco in studio
    E.5.2Secondary end point(s)
    - Factor VIII (FVIII) activity level after the onset of steady state and through 12 months following infusion of PF-07055480.
    - Annualized infusion rate (AIR) of exogenous FVIII through 12 months following infusion of PF-07055480 versus AIR on prior FVIII prophylaxis replacement regimen.
    - The following secondary parameters will be assessed through 12 months after PF-07055480 infusion and compared with prior FVIII prophylaxis replacement regimen:
    • Annualized FVIII consumption.
    • Annualized bleeding rate (ABR) of specific type (from Week 3):
    o by cause (spontaneous or traumatic)
    o by location (in joints, in target joints, or in soft tissue).
    • Total ABR (treated and untreated) from Week 3.
    • Total ABR by location (in joints, in target joints, or in soft tissue) from Week 3.
    • Percentage of participants without bleeds.
    • Change in joint health as measured by the Hemophilia Joint Health Score (HJHS) instrument.
    • Change from baseline at 12 months in the following patient-reported outcome (PRO) endpoints:
    o Haemophilia Quality of Life Questionnaire for Adults (Haem-AQoL)
    o Haemophilia Activities List (HAL).
    - The following parameters will be analysed yearly and throughout the 5-year study period:
    • ABR.
    • Steady state FVIII activity level.
    • AIR of exogenous FVIII.
    • Annualized FVIII consumption.
    • ABR of specific type:
    o by cause (spontaneous or traumatic).
    o by location (in joint, in target joints, or in soft tissue).
    • Total ABR (treated and untreated).
    • Total ABR by location (in joint, in target joints, or in soft tissue).
    • Percentage of participants without bleeds.
    • Change in joint health as measured by the HJHS instrument.
    • Change in PRO endpoints: Haem-A-QoL and HAL.
    - Incidence and severity of adverse events (AEs).
    - Events of special interest (such as hypersensitivity reactions, clinically reported thrombotic events, and malignancy).
    - Immunogenicity:
    • Antibodies against adeno-associated virus 6 (AAV6) capsid protein (neutralizing antibodies [nAbs] and anti-drug antibodies [ADAs]).
    • T-cell responses against AAV6 capsid and against the transgene.
    • FVIII inhibitors.
    - Livello di attività del fattore VIII (FVIII) dopo l'inizio dello stato stazionario e per 12 mesi dopo l'infusione di PF-07055480.
    - Velocità di infusione annualizzata (AIR) di FVIII esogeno per 12 mesi dopo l'infusione di PF-07055480 rispetto a AIR su un precedente regime sostitutivo della profilassi con FVIII.
    - I seguenti parametri secondari saranno valutati per 12 mesi dopo l'infusione di PF-07055480 e confrontati con il precedente regime di sostituzione della profilassi con FVIII:
    • Consumo annualizzato di FVIII.
    • Tasso di sanguinamento annualizzato (ABR) di tipo specifico (dalla settimana 3):
    o per causa (spontanea o traumatica)
    o in base alla posizione (nelle articolazioni, nelle articolazioni bersaglio o nei tessuti molli).
    • ABR totale (trattato e non trattato) dalla settimana 3.
    • ABR totale per posizione (nelle articolazioni, nelle articolazioni target o nei tessuti molli) dalla settimana 3.
    • Percentuale di partecipanti senza sanguinamento.
    • Cambiamento nella salute delle articolazioni misurato dallo strumento Hemophilia Joint Health Score (HJHS).
    • Variazione rispetto al basale a 12 mesi nei seguenti endpoint di outcome riferito dal paziente (PRO):
    o Questionario sulla qualità della vita dell'emofilia per adulti (Haem-AQoL)
    o Elenco attività emofilia (HAL).
    - I seguenti parametri saranno analizzati annualmente e durante il periodo di studio di 5 anni:
    • ABR.
    • Livello di attività del FVIII allo stato stazionario.
    • ARIA di FVIII esogeno.
    • Consumo annualizzato di FVIII.
    • ABR di tipo specifico:
    o per causa (spontanea o traumatica).
    o per posizione (nell'articolazione, nelle articolazioni bersaglio o nei tessuti molli).
    • ABR totale (trattato e non trattato).
    • ABR totale in base alla posizione (nell'articolazione, nelle articolazioni target o nei tessuti molli).
    • Percentuale di partecipanti senza sanguinamento.
    • Cambiamento nella salute delle articolazioni misurato dallo strumento HJHS.
    • Modifica degli endpoint PRO: Haem-A-QoL e HAL.
    - Incidenza e gravità degli eventi avversi (EA).
    - Eventi di particolare interesse (come reazioni di ipersensibilità, eventi trombotici riportati clinicamente e tumori maligni).
    - Immunogenicità:
    • Anticorpi contro la proteina del capside del virus adeno-associato 6 (AAV6) (anticorpi neutralizzanti [nAbs] e anticorpi anti-farmaco [ADA]).
    • Risposte dei linfociti T contro il capside AAV6 e contro il transgene.
    • Inibitori di FVIII.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - ABR: yearly (after the primary analysis at 12 months) and up to 5 years
    - FVIII activity level: through 12 months, then yearly and up to 5 years
    - AIR of exogenous FVIII, annualized FVIII consumption, percentage of participants without bleeds, change in joint health as measured by the HJHS instrument, change in PRO endpoints (Haem-A-QoL and HAL): through 12 months, then yearly and up to 5 years
    - ABR of specific type, total ABR (treated and untreated), total ABR by location (in joints, in target joints, or in soft tissue): from Week 3 through 12 months, then yearly and up to 5 years
    - Incidence and severity of AEs, events of special interest, immunogenicity: Up to 5 years.
    - ABR: annuale (dopo l'analisi primaria a 12 mesi) e fino a 5 anni
    - Livello di attività del FVIII: per 12 mesi, poi annuale e fino a 5 anni
    - ARIA di FVIII esogeno, consumo annualizzato di FVIII, percentuale di partecipanti senza sanguinamento, variazione della salute articolare misurata dallo strumento HJHS, variazione degli endpoint PRO (Haem-A-QoL e HAL): per 12 mesi, poi annuale e fino a 5 anni
    - ABR di tipo specifico, ABR totale (trattato e non trattato), ABR totale per posizione (nelle articolazioni, nelle articolazioni target o nei tessuti molli): dalla settimana 3 fino a 12 mesi, poi annuale e fino a 5 anni
    - Incidenza e gravità degli eventi avversi, eventi di particolare interesse, immunogenicità: fino a 5 anni.
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    Studio in aperto a braccio singolo
    Open-label single-arm study
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Australia
    Brazil
    Canada
    Israel
    Japan
    Korea, Republic of
    Saudi Arabia
    Taiwan
    Turkey
    United States
    Belgium
    France
    Germany
    Greece
    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
    A participant is considered to have completed the study if he/she has completed the entire study including endo of study (EOS) visit (Week 260).
    The end of the study is defined as the date of the EOS visit of the last participant in the study.
    Si considera che un partecipante abbia completato lo studio se ha completato l'intero studio, inclusa la visita di fine studio (alla Settimana 260).
    La fine dello studio è definita come la data della visita di fine studio dell'ultimo partecipante allo studio.
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months2
    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: 63
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 63
    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 tale 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 Decision2021-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
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