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    Summary
    EudraCT Number:2019-004451-37
    Sponsor's Protocol Code Number:C3731003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2021-10-15
    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 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%)
    Estudio de fase 3 sin enmascaramiento y de un solo grupo para evaluar la eficacia y la seguridad de PF-07055480 (terapia génica con el VAA2/6 recombinante/factor VIII humano) en varones adultos con hemofilia A entre moderadamente grave y grave (FVIII: C ≤ 1 %)
    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
    Un estudio para evaluar la eficacia y la seguridad de PF-07055480 como terapia génica con Factor VIII en varones adultos con hemofilia A entre moderadamente grave y grave
    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., 235 East 42nd Street, New York, NY 10017
    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 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 vector genomes (vg)/mL
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000000000
    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
    Hemofilia 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
    Trastorno heredado provocado por ausencia de Factor VIII que es requerido para que la sangre coagule y detenga una hemorragia
    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.1.3Condition 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%).
    Evaluar la eficacia de una sola infusión de PF-07055480 en participantes ≥ 18 y < 65 años de edad con hemofilia A entre moderadamente grave y 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.
    - Poner de manifiesto que el uso de FVIII exógeno se redujo de forma significativa tras la infusión de PF-07055480.
    - Comparar los parámetros de eficacia adicionales tras la infusión de PF-07055480, incluido el uso de FVIII exógeno, información sobre los episodios hemorrágicos y los RPP.
    - Estimar la durabilidad de la eficacia hasta 5 años después de la infusión de PF-07055480.
    - Estimar la seguridad y la tolerabilidad de PF-07055480, incluida la inmunogenicidad, durante los 5 años siguientes que dure el estudio tras la infusión de 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
    - 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.
    - Subestudio opcional de eliminación de vectores, 10 Dic 2019, Versión 1: Caracterización adicional de la cinética de eliminación de vectores.

    - Subestudio opcional de ecografía de las articulaciones, 10 Dic 2019, Versión 1: Comparar y evaluar la salud articular tras la infusión de PF-07055480 respecto al valor inicial mediante ecografía.

    - Subestudio opcional de radiografía de las articulaciones, 11 Ago 2019, Versión 1: Comparar la salud articular tras la infusión de PF-07055480 respecto al valor inicial y valorar las articulaciones a largo plazo mediante radiografía.
    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
    • Hombres que hayan completado al menos 6 meses el tratamiento profiláctico de rutina con FVIII durante el estudio de preinclusión (C0371004) al comienzo del periodo de selección y haber pasado por ≥ 150 días de exposición documentada a un producto proteínico del FVIII
    • Hemofilia entre moderadamente grave y grave (actividad del FVIII ≤ 1 %)
    • Suspensión del tratamiento profiláctico con FVIII tras la administración de la intervención del estudio
    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
    • Anticuerpos neutralizantes contra el AAV6
    • Antecedentes de inhibidores del FVIII
    • Valores de laboratorio en la visita de inicio anormales o fuera de los límites aceptables del estudio
    • Enfermedad significativa/inestable actual del hígado, de la vesícula biliar, fibrosis hepática significativa
    • Procedimiento quirúrgico planificado que precise de tratamiento con un factor profiláctico quirúrgico del FVIII en los 12 meses siguientes a la visita de inicio
    • Hepatitis B o C en curso
    • Indicios serológicos de la presencia de VIH-1 o VIH-2 con recuento de células CD4+ ≤ 200 mm3 y/o carga vírica > 20 copias/mL
    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 (hemorragias espontáneas y traumáticas) durante los primeros 12 meses tras la infusión de PF-07055480 (a partir de la Semana 3) frente a ABR en el régimen anterior de sustitución profiláctica del FVIII.
    E.5.1.1Timepoint(s) of evaluation of this end point
    from Week 3 to 12 months (primary analysis) post study drug infusion.
    3 a 12 meses (análisis primario) tras infusión del medicamento del estudio.
    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):
    - by cause (spontaneous or traumatic),
    - 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:
    - Haemophilia Quality of Life Questionnaire for Adults (Haem-A-QoL),
    - 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:
    - by cause (spontaneous or traumatic).
    - 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.
    - Nivel de actividad del FVIII de los primeros 12 meses tras la infusión de PF-07055480.
    - AIR del FVIII exógeno a lo largo de 12 meses tras la infusión de PF-07055480 frente a AIR en el régimen anterior de sustitución profiláctica del FVIII.
    - Se valorarán los parámetros secundarios siguientes a lo largo de 12 meses tras una infusión de PF-07055480 y se compararán con el régimen anterior de sustitución profiláctica del FVIII:
    • Consumo anualizado de FVIII.
    • ABR de tipo específico (a partir de la Semana 3):
    - por causa (espontánea o traumática),
    - por localización (en las articulaciones, en las articulaciones diana o en el tejido blando).
    • ABR total (episodios tratados o sin tratar) a partir de la Semana 3.
    • ABR total por localización (en las articulaciones, en las articulaciones diana o en el tejido blando) a partir de la Semana 3.
    • Porcentaje de participantes sin hemorragias articulaciones medido con el instrumento HJHS.
    • Cambio con respecto al valor inicial a los 12 meses en los siguientes criterios de valoración de los RPP:
    - Haem-A-QoL,
    - HAL.
    - Los parámetros siguientes se analizarán cada año durante un periodo de estudio de 5 años:
    • ABR.
    • Actividad del FVIII en estado estable.
    • AIR del FVIII exógeno.
    • Consumo anualizado de FVIII.
    • ABR de tipo específico:
    - por causa (espontánea o traumática),
    - por localización (en las articulaciones, en las articulaciones diana o en el tejido blando).
    • ABR total (episodios tratados o sin tratar).
    • ABR total por localización (en las articulaciones, en las articulaciones diana o en el tejido blando).
    • Porcentaje de participantes sin hemorragias.
    • Cambio en el estado de salud de las articulaciones medido con el instrumento HJHS.
    • Cambio en los criterios de valoración de los RPP: Haem-A-QoL y HAL.
    - Incidencia y gravedad de los AA.
    - Acontecimientos de especial interés (como reacciones de hipersensibilidad, episodios trombóticos notificados en el ámbito clínico y tumores).
    - Inmunogenicidad:
    • Anticuerpos frente a las proteínas de la cápside del AAV6 (nAbs y ADA).
    • Respuestas de los linfocitos T frente a las proteínas de la cápside del AAV6 y frente al transgén.
    • Inhibidores del 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: anualmente (tras análisis primario a los 12 meses) y hasta 5 años
    - Actividad de FVIII: durante 12 meses, después anualmente hasta 5 años
    - AIR de FVIII exógeno, consumo anualizado de FVIII, porcentaje de participantes sin hemorragias, cambio en el estado de salud de las articulaciones medido con el instrumento HJHS, cambio en los criterios de valoración de los RPP (Haem-A-QoL y HAL): durante 12 meses, después anualmente hasta 5 años
    - ABR de tipo específico, ABR total (episodios tratados o sin tratar), ABR total por localización (en las articulaciones, en las articulaciones diana o en el tejido blando): a partir de la semana 3 durante 12 meses, después anualmente hasta 5 años
    - Incidencia y gravedad de los AA, acontecimientos de especial interés, inmunogenicidad: hasta 5 años
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Australia
    Brazil
    Canada
    Israel
    Japan
    Korea, Republic of
    Saudi Arabia
    Taiwan
    Turkey
    United States
    Belgium
    France
    Germany
    Italy
    Spain
    Sweden
    United Kingdom
    Greece
    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 has completed the entire study including end 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.
    Se considera que un participante ha acabado el estudio si ha completado la totalidad del ensayo incluyendo la visita de fin de estudio (Semana 260).
    El final del estudio se define como la fecha de la visita de fin de estudio del último participante en el mismo.
    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 state5
    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.
    El mismo que el tratamiento normal esperado the esa patología.
    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 Decision2020-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-20
    P. End of Trial
    P.End of Trial StatusRestarted
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