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    Summary
    EudraCT Number:2012-005489-37
    Sponsor's Protocol Code Number:CSL654_3003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-10
    Trial results View 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 number2012-005489-37
    A.3Full title of the trial
    A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects with Hemophilia B
    Estudio de extensión de Fase IIIb, abierto, multicéntrico, sobre la seguridad y eficacia de una proteína de fusión del factor IX recombinante de la coagulación con la albúmina (rIX-FP) en pacientes con hemofilia B.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia B
    Estudio de extensión de seguridad y eficacia de una Proteína de fusión recombinante que une el factor de coagulación IX con la albúmina (rIX-FP) en pacientes con hemofilia B.
    A.4.1Sponsor's protocol code numberCSL654_3003
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/251/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCSL Behring GmbH
    B.1.3.4CountryGermany
    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 supportCSL Behring GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCSL Behring GmbH
    B.5.2Functional name of contact pointClinical Trial Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressEmil-von-Behring Straße 76
    B.5.3.2Town/ cityMarburg
    B.5.3.3Post code35041
    B.5.3.4CountryGermany
    B.5.4Telephone number049642139 3304
    B.5.5Fax number049642139 4196
    B.5.6E-mailclinicaltrials@cslbehring.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 numberEMEA/OD/117/09
    D.3 Description of the IMP
    D.3.1Product nameRecombinant fusion protein linking coagulation factor IX with Albumin
    D.3.2Product code CSL654
    D.3.4Pharmaceutical form Powder for concentrate for 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 INNalbutrepenonacog alfa
    D.3.9.1CAS number 1357448-54-4
    D.3.9.2Current sponsor codeCSL654 or rIX-FP
    D.3.9.3Other descriptive nameRecombinant Fusion Protein Linking Coagulation Factor Ix with Albumin
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 2
    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 numberEMEA/OD/117/09
    D.3 Description of the IMP
    D.3.1Product nameRecombinant fusion protein linking coagulation factor IX with Albumin
    D.3.2Product code CSL654
    D.3.4Pharmaceutical form Powder for concentrate for 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 INNalbutrepenonacog alfa
    D.3.9.1CAS number 1357448-54-4
    D.3.9.2Current sponsor codeCSL654 or rIX-FP
    D.3.9.3Other descriptive nameRecombinant Fusion Protein Linking Coagulation Factor IX with Albumin
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 3
    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 numberEMEA/OD/117/09
    D.3 Description of the IMP
    D.3.1Product nameRecombinant fusion protein linking coagulation factor IX with Albumin
    D.3.2Product code CSL654
    D.3.4Pharmaceutical form Powder for concentrate for 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 INNalbutrepenonacog alfa
    D.3.9.1CAS number 1357448-54-4
    D.3.9.2Current sponsor codeCSL654 or rIX-FP
    D.3.9.3Other descriptive nameRecombinant Fusion Protein Linking Coagulation Factor IX with Albumin
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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.IMP: 4
    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 numberEMEA/OD/117/09
    D.3 Description of the IMP
    D.3.1Product nameRecombinant fusion protein linking coagulation factor IX with Albumin
    D.3.2Product code CSL654
    D.3.4Pharmaceutical form Powder for concentrate for 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 INNalbutrepenonacog alfa
    D.3.9.1CAS number 1357448-54-4
    D.3.9.2Current sponsor codeCSL654 or rIX-FP
    D.3.9.3Other descriptive nameRecombinant Fusion Protein Linking Coagulation Factor IX with Albumin
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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 B
    Hemofilia B
    E.1.1.1Medical condition in easily understood language
    Hemophilia B
    Hemofilia B
    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 16.1
    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 evaluate the safety of rIX-FP as measured by new cases of inhibitors against FIX in subjects with severe hemophilia B.
    Evaluar la seguridad de rIX-FP determinada por los nuevos de casos de inhibidores del FIX en pacientes con hemofilia B grave.
    E.2.2Secondary objectives of the trial
    ? To evaluate the efficacy of rIX-FP routine prophylaxis when administrated at various treatment intervals
    ? To compare the efficacy of rIX-FP routine prophylaxis between two different treatment intervals and versus on-demand treatment
    ? To further evaluate the safety of rIX-FP
    ? Evaluar la eficacia de la profilaxis de rutina con rIX-FP cuando se administra a distintos intervalos de tratamiento.
    ? Comparar la eficacia de la profilaxis de rutina con rIX-FP entre 2 intervalos de tratamiento distintos y frente al tratamiento a demanda.
    ? Evaluar más en profundidad la seguridad de rIX-FP.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subjects may participate in a surgical 'substudy' in which rIX-FP may be administered before, during and after surgery. The substudy will examine the safety and efficacy of rIX-FP in patients with hemophilia B who are undergoing surgery. The objectives of the substudy are to evaluate the efficacy of rIX-FP in the prevention and control of bleeding in patients with severe hemophilia B during surgical procedures and to evaluate the safety of rIX-FP during the intraoperative and postoperative periods.
    Los sujetos pueden participar en un sub-estudio quirúrgico en el que se podrá administrar rIX-FP antes, durante y después de la cirugía. El sub-estudio evaluará la seguridad y eficacia de rIX-FP en pacientes con hemofilia b que son operados quirúrgicamente. Los objetivos del sub-estudio son evaluar la eficacia de rIX-FP en la prevención y el control de hemorragias en pacientes con hemofilia B grave durante procedimientos quirúrgicos y evaluar la seguridad de rIX-FP durante los periodos intraoperatorio y postoperatorio.
    E.3Principal inclusion criteria
    ? Male subjects, up to 65 years old
    ? Participated in a CSL-sponsored rIX-FP (CSL654) study, including study CSL654_3001 or study CSL654_3002.
    ? Sujetos varones, hasta 65 años.
    ? Haber participado en algún estudio con rIX-FP promocionado por CSL (CSL654), incluidos el estudio CSL654_3001 o el estudio CSL654_3002.
    E.4Principal exclusion criteria
    ? Unwilling to participate in the study for a total of 100 exposure days.
    ? Currently receiving a therapy not permitted during the study.
    ? Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the study.
    ? No estar dispuesto a participar en el estudio durante un total de 100 días de exposición.
    ? Estar recibiendo actualmente algún tratamiento no permitido durante el estudio
    ? Cualquier otro motivo que, en opinión del investigador, hiciera al paciente no apto para participar en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Total number of subjects who develop inhibitors against factor IX (FIX)
    Número total de sujetos que desarrollan inhibidores contra el factor IX (FIX).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 3 years
    Aproximadamente 3 años
    E.5.2Secondary end point(s)
    ? Comparison of annualized bleeding rate between different prophylaxis treatment intervals.
    ? Comparison of annualized bleeding rate between 2 different prophylaxis treatment intervals and on-demand treatment.
    ? rIX-FP consumed per month per subject during routine prophylaxis treatment.
    ? Comparación del índice de hemorragia anualizado entre distintos intervalos de tratamiento profiláctico.
    ? Comparación del índice de hemorragia anualizado entre 2 intervalos de tratamiento profiláctico y tratamiento a demanda.
    ?rIX-FP consumido por mes y por sujeto durante el tratamiento profiláctico rutinario.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 3 years for annualized bleeding rate analysis for prophylaxis treatment and rIX-FP consumed; at least 3 months and up to 6 months for annualized bleeding rate analysis with on-demand treatment.
    Aproximadamente 3 años para el análisis del índice de hemorragia anualizado para el tratamiento profiláctico y rIX-FP consumido; al menos 3 meses y hasta 6 meses para el análisis del índice de hemorragia anualizado con tratamiento a demanda.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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.8.3 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Bulgaria
    Canada
    France
    Italy
    Japan
    Austria
    Australia
    Czech Republic
    Germany
    Spain
    Israel
    Russian Federation
    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
    The end of the trial is defined as the last-patient-last-visit.
    El fin de estudio se define como la última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    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 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 22
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 7
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 55
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    This clinical trial will be conducted in adults but also in children in different age groups; including children younger than 12 years of age.
    Este ensayo clínico se realizará con adultos pero también con niños en distintos grupos de edad, incluyendo niños menores de 12 años de edad.
    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 72
    F.4.2.2In the whole clinical trial 85
    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)
    If a subject is withdrawn from the study or further participation is declined, they will continue to have access to medical care and will be treated as per routine medical practice.
    Si un sujeto es retirado del estudio o rechaza continuar con su participación, seguirá teniendo acceso a asistencia médica y será tratado según la práctica médica habitual.
    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 Decision2013-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-02
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