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    Summary
    EudraCT Number:2017-001255-31
    Sponsor's Protocol Code Number:B7841003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-21
    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 number2017-001255-31
    A.3Full title of the trial
    A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS OR INTRAVENOUS
    PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA
    ESTUDIO MULTICÉNTRICO, ABIERTO PARA EVALUAR LA SEGURIDAD, LA TOLERABILIDAD Y LA EFICACIA A LARGO PLAZO DE PF-06741086 ADMINISTRADO POR VÍA SUBCUTÁNEA O INTRAVENOSA A PACIENTES CON HEMOFILIA GRAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS OR INTRAVENOUS
    PF-06741086 IN SUBJECTS WITH SEVERE HEMOPHILIA
    ESTUDIO MULTICÉNTRICO, ABIERTO PARA EVALUAR LA SEGURIDAD, LA TOLERABILIDAD Y LA EFICACIA A LARGO PLAZO DE PF-06741086 ADMINISTRADO POR VÍA SUBCUTÁNEA O INTRAVENOSA A PACIENTES CON HEMOFILIA GRAVE
    A.4.1Sponsor's protocol code numberB7841003
    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 center
    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+3491490 99 00
    B.5.5Fax number+1303739 1119
    B.5.6E-mailclinicaltrials.govCallCenter@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/3/16/1752
    D.3 Description of the IMP
    D.3.1Product namePF-06741086 100mg/ml
    D.3.2Product code PF-06741086
    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 INNPF-06741086
    D.3.9.3Other descriptive namePF-06741086
    D.3.9.4EV Substance CodeSUB187130
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    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
    Hemophilia A or B
    Hemofilia A o B
    E.1.1.1Medical condition in easily understood language
    Severe Hemophilia A or B
    Hemofilia A o B grave
    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 10060612
    E.1.2Term Hemophilia A
    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 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 determine the safety and tolerability of long term treatment (continuous 6 months) with PF 06741086 in severe hemophilia A and B subjects.
    •Determinar la seguridad y tolerabilidad del tratamiento a largo plazo (6 meses continuos) con PF 06741086 en sujetos con hemofilia A o B grave.
    E.2.2Secondary objectives of the trial
    •To determine the efficacy of long term treatment with PF 06741086 in severe hemophilia A and B subjects.
    •Determinar la eficacia del tratamiento a largo plazo con PF 06741086 en sujetos con hemofilia A o B grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects must meet the following inclusion criteria to be eligible for enrollment into the study. Subjects continuing from B7841002 within 30 days of the B7841003 Day 1 visit do not require screening procedures to confirm eligibility:
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative/parent(s)/legal guardian) has been informed of all pertinent aspects of the study.
    2. Males ≥18 and <65 years of age.
    3. Body Mass Index (BMI) ≥17.5 and ≤30.5 kg/m2 and total body weight ≥50 and ≤100 kg.
    4. Diagnosis of severe hemophilia A or B (FVIII or FIX activity ≤1%).
    5. If receiving therapy for human immunodeficiency virus (HIV) or active hepatitis infection, have stable disease and be on a stable regimen at the time of study entry (ie, stable dosing for at least 3 months before consent).
    6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    The following inclusion criteria only apply to de novo subjects only:
    1. Patients with an episodic (on demand) treatment regimen prior to Screening, who are willing and able to washout from Factor VIII (for at least 72 hours) or Factor IX (for at least 96 hours) replacement therapy prior to Screening laboratory assessments of factor activity and have no plans to institute prophylactic factor treatment during the study period.
    2. Had at least 6 acute bleeding episodes (spontaneous/traumatic) during the 6 month period prior to Screening. Surgical bleeding episodes do not apply to this criterion.
    Para ser aptos para participar en el estudio, todos los sujetos deben reunir los criterios de inclusión siguientes. Los sujetos provenientes del estudio B7841002, cuya participación continuada en este estudio comience en el plazo de 30 días previos a la visita del día 1 de B7841003, no tendrán que someterse a los procedimientos de selección para confirmar que son aptos:
    1. Presentar pruebas de posesión de un documento de consentimiento informado firmado y fechado que indique que se le han informado al sujeto (o a uno de los padres/un tutor legal/un representante legal) todos los aspectos pertinentes del estudio.
    2. Ser varón y tener ≥ 18 y < 65 años de edad.
    3. Tener un índice de masa corporal (IMC) ≥ 17.5 y ≤ 30,5 kg/m2 y un peso corporal total ≥ 50 y ≤100 kg.
    4. Haber recibido un diagnóstico de hemofilia A o B grave (actividad del FVIII o el FIX ≤1%).
    5. Si el paciente está recibiendo tratamiento para una infección activa por el virus de la inmunodeficiencia humana (VIH) o por el virus de la hepatitis, la enfermedad debe estar estable y se debe estar administrando una pauta posológica estable al momento de ingresar en el estudio (es decir, debe haber recibido un tratamiento estable durante al menos 3 meses antes del momento de dar el consentimiento).
    6. Estar dispuesto y ser capaz de cumplir con las visitas del estudio, el plan de tratamiento, las pruebas analíticas y otros procedimientos del estudio.
    Los criterios de inclusión siguientes solo conciernen a los sujetos de novo:
    1. Pacientes a los que se les está administrando una pauta posológica episódica (a petición) antes de la selección, que estén dispuestos y sean capaces de hacer un reposo farmacológico del tratamiento de reposición del factor VIII (durante al menos 72 horas) o del factor IX (durante al menos 96 horas), antes de las evaluaciones analíticas de selección de la actividad factorial, y que no tengan prevista la institución de un tratamiento profiláctico factorial durante el período del estudio.
    2. Haber tenido al menos 6 hemorragias agudas (espontáneas/traumáticas) durante los 6 meses anteriores a la selección. Las hemorragias quirúrgicas no son aplicables a este criterio.
    E.4Principal exclusion criteria
    Subjects with any of the following characteristics/conditions will not be included in the study:
    1. Females.
    2. Known coronary artery, thrombotic, or ischemic disease.
    3. Known hemostatic defect other than hemophilia A or B.
    4. ATIII, Protein C, or Protein S deficiency, Factor V Leiden, Prothrombin 20210 mutation, or other known pro thrombotic condition.
    5. Regular, concomitant therapy with immunomodulating drugs (eg, intravenous immunoglobulin [IVIG], and routine systemic corticosteroids).
    6. Detectable or documented history of inhibitors (≥0.6 Bethesda Units [BU]) against Factor VIII or Factor IX during the 12 month period prior to Screening.
    7. Abnormal renal or hepatic function as defined by the following laboratory results at any time prior to Day 1:
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels >3 times the upper limit of normal (ULN).
    • Total bilirubin level >2 mg/dL (>35 µmol/L).
    • Serum albumin < the lower limit of normal (LLN).
    • Serum creatinine level >1.25 times the ULN.
    8. Abnormal hematology values as defined by the following laboratory results at any time prior to Day 1:
    • Platelet count <100,000/µL.
    • Fibrinogen level < LLN.
    • Hemoglobin level <10 gm/dL.
    9. Abnormal coagulation activity as defined by the following laboratory results at any time prior to Day 1:
    • Prothrombin time (PT) >1.25 times the ULN.
    10. CD4 cell count ≤200/µL.
    11. Known hypersensitivity or allergic reaction to hamster protein.
    12. Known sensitivity to heparin or heparin induced thrombocytopenia.
    13. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
    14. Participation in other studies involving investigational drug(s) (excluding PF 06741086) within 30 days prior to study entry and/or during study participation.
    15. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    16. Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
    17. Had major surgery, as judged by the investigator, within 3 months prior to the study or have elective surgery planned during the study (applies only to de novo subjects).
    Los sujetos que reúnan los criterios o presenten cualquiera de las características/afecciones siguientes no se incluirán en el estudio:
    1. Mujeres.
    2. Arteria coronaria, trombosis o cardiopatía isquémica conocidas.
    3. Defecto hemostático conocido que no sea hemofilia A o B.
    4. Deficiencia de ATIII, proteína C o proteína S, mutación del factor V Leiden, mutación del gen 20210 de la protrombina u otras afecciones protrombóticas conocidas.
    5. Tratamiento pautado concomitante con inmunomoduladores (por ejemplo, inmunoglobulinas intravenosas [IGIV] y corticoesteroides sistémicos ordinarios).
    6. Antecedentes detectables o documentados del uso de inhibidores ( 0,6 unidades de Bethesda [UB]) del factor VIII o el factor IX durante los 12 meses anteriores a la selección.
    7. Anomalías en la función renal o hepática, definidas mediante los resultados analíticos siguientes en cualquier momento antes del día 1:
    • Niveles de alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) > 3 veces el nivel superior de la normalidad (LSN).
    • Niveles de bilirrubina total > 2 mg/dl (> 35 mol/l).
    • Seroalbúmina < límite inferior de la normalidad (LIN).
    • Niveles de creatinina sérica > 1,25 veces el LSN.
    8. Anomalías en los valores hemáticos, definidas mediante los resultados analíticos siguientes en cualquier momento antes del día 1:
    • Número de trombocitos < 100 000//µL.
    • Nivel de fibrinógeno < LIN.
    • Nivel de hemoglobina < 10 gm/dl.
    9. Anomalías en la actividad coagulante, definidas mediante los resultados analíticos siguientes en cualquier momento antes del día 1:
    • Tiempo de protrombina (TP) > 1,25 veces el LSN.
    10. Recuento de linfocitos CD4 ≤ 200/µL.
    11. Hipersensibilidad o reacción alérgica conocida a la proteína de hámster.
    12. Sensibilidad conocida a la trombocitopenia inducida por heparina.
    13. Integrantes del personal del investigador involucrados en la realización del estudio y sus familiares, los integrantes del personal del centro supervisados de otra forma por el investigador y sujetos que sean empleados de Pfizer (incluidos sus familiares) que participen directamente en la realización del estudio.
    14. Participación en otros estudios de fármacos experimentales (excluido el PF 06741086) dentro de los 30 días anteriores al ingreso en el estudio y/o durante la participación en el estudio.
    15. Otras afecciones médicas o psiquiátricas, agudas o crónicas, incluidas ideas de suicidio recientes (durante el año pasado) o ideas o conducta de suicidio actuales, o anomalías en los resultados analíticos que puedan aumentar los riesgos asociados a la participación en el estudio o la administración del producto experimental, o que puedan interferir con la interpretación de los resultados del estudio y que, en la opinión del investigador, causarían que el ingreso del sujeto en este estudio sea inadecuado.
    16. Sujetos varones capaces de procrear y que no estén dispuestos o no puedan utilizar un método anticonceptivo de gran eficacia, como se resume en este protocolo, durante todo el estudio y durante al menos 28 días después de la última dosis del producto en investigación.
    17. Sujetos que se han sometido a cirugía mayor, según la opinión del investigador, durante los 3 meses anteriores al estudio o se someten durante el estudio a una intervención quirúrgica programada (solo aplicable a los sujetos de novo).
    E.5 End points
    E.5.1Primary end point(s)
    •Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs); Day 1 up to Day 197.
    •Frequency and magnitude of abnormal laboratory findings (including hematology, chemistry, urinalysis); Day 1 up to Day 197.
    •Changes from baseline in vital sign (blood pressure, pulse rate, temperature and respiration rate) measurements and physical examinations; Day 1 up to Day 197 and ECG Day 1 to Day 29 in de novo subjects only.
    •Frequency, severity and casual relationship of infusion and injection site reactions; Day 1 up to Day 197.
    •La frecuencia, la intensidad y la relación causal de los acontecimientos adversos observados durante el tratamiento (AADT); día 1 a día 197.
    •La frecuencia y la magnitud de los hallazgos analíticos anómalos (incluidos de hematología, bioquímica, análisis de orina); día 1 a día 197.
    •Cambios dese el inicio en las constantes vitales (tensión arterial, pulso, temperatura y frecuencia respiratoria), mediciones y exploraciones físicas; día 1 hasta día 197, y ECG; día 1 a día 29 (solo en sujetos de novo).
    •La frecuencia, la intensidad y la relación causal entre la infusión y las reacciones en el lugar de la inyección; día 1 a día 197.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints are all listed in the list of primary endpoints.
    Los momentos de evaluación están incluiods en la lista de criterios primarios de evaluación.
    E.5.2Secondary end point(s)
    •Frequency and annualized rate of bleeding episodes; Day 1 up to Day 197.
    •Frequency of rescue (FVIII, or FIX) therapy for treatment of breakthrough bleeding episodes.
    •La frecuencia y la tasa anualizada de hemorragias; día 1 a día 197.
    •La frecuencia del tratamiento de rescate (FVII y FIX) para las recaídas hemorrágicas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints are all listed in the list of secondary endpoints.
    Los momentos de evaluación están incluiods en la lista de criterios secundarios de evaluación.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    Tolerability
    Tolerabilidad
    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 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 trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Brazil
    Bulgaria
    Chile
    Croatia
    France
    Malaysia
    Poland
    South Africa
    Spain
    Switzerland
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LSLV
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 36
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 36
    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)
    none
    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 Decision2017-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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