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    Summary
    EudraCT Number:2013-001556-35
    Sponsor's Protocol Code Number:GENA-21
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-04
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2013-001556-35
    A.3Full title of the trial
    Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of individually tailored prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe haemophilia A
    Prospektív, nyílt, többközpontú Fázis IIIb vizsgálat a Human-cl rhFVIII segítségével egyedileg beállított megelőzés hatásosságára és biztonságosságára a korábban súlyos hemofília A-val kezelt felnőtt betegek esetében.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the efficacy and safety of individually tailored prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe haemophilia A
    Egyedileg beállított Human-cl rhFVIII hatásosságának és biztonságosságának vizsgálata korábban súlyos hemofília A-val kezelt felnőtt betegek esetében.
    A.4.1Sponsor's protocol code numberGENA-21
    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 SponsorOctapharma AG
    B.1.3.4CountrySwitzerland
    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 supportOctapharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOctapharma AG
    B.5.2Functional name of contact pointJohann Bichler
    B.5.3 Address:
    B.5.3.1Street AddressSeidenstrasse 2
    B.5.3.2Town/ cityLachen
    B.5.3.3Post code8853
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+4155451 21 77
    B.5.5Fax number+4155451 21 51
    B.5.6E-mailjohann.bichler@octapharma.ch
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHuman cell-line derived recombinant human factor VIII
    D.3.2Product code Human-cl rhFVIII
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNsimoctocog alfa
    D.3.9.2Current sponsor codeHuman-cl rhFVIII
    D.3.9.3Other descriptive nameHUMAN COAGULATION FACTOR VIII (RDNA)
    D.3.9.4EV Substance CodeSUB13815MIG
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHuman cell-line derived recombinant human factor VIII
    D.3.2Product code Human-cl rhFVIII
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNsimoctocog alfa
    D.3.9.2Current sponsor codeHuman-cl rhFVIII
    D.3.9.3Other descriptive nameHUMAN COAGULATION FACTOR VIII (RDNA)
    D.3.9.4EV Substance CodeSUB13815MIG
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHuman cell-line derived recombinant human factor VIII
    D.3.2Product code Human-cl rhFVIII
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNsimoctocog alfa
    D.3.9.2Current sponsor codeHuman-cl rhFVIII
    D.3.9.3Other descriptive nameHUMAN COAGULATION FACTOR VIII (RDNA)
    D.3.9.4EV Substance CodeSUB13815MIG
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHuman cell-line derived recombinant human factor VIII
    D.3.2Product code Human-cl rhFVIII
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNsimoctocog alfa
    D.3.9.2Current sponsor codeHuman-cl rhFVIII
    D.3.9.3Other descriptive nameHUMAN COAGULATION FACTOR VIII (RDNA)
    D.3.9.4EV Substance CodeSUB13815MIG
    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
    Severe haemophilia A
    Súlyos hemofília A
    E.1.1.1Medical condition in easily understood language
    Severe bleeding disorder
    Súlyos vérzési rendellenesség
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10018938
    E.1.2Term Haemophilia A (Factor VIII)
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the annualized total bleeding rate of individually tailored prophylaxis
    with the historical bleeding rate observed in patients having received on-demand
    treatment with Human-cl rhFVIII from study GENA-01
    Összehasonlítani az egyénileg beállított profilaxisú betegek egy évre eső vérzéses eseményeinek arányát olyan betegek kórtörténetében feltüntetett vérzéses események arányával, akik szükség szerint kaptak kezelést Human-cl rhFVIII-ral a GENA-01 vizsgálatban
    E.2.2Secondary objectives of the trial
    1. To compare the annualized spontaneous bleeding rate of individually tailored prophylaxis with the historical bleeding rate observed in patients having received
    on-demand treatment with Human-cl rhFVIII
    2. To compare the annualized total bleeding rate in patients with 2x/week (or less) prophylaxis with the historical bleeding rate observed in patients having received on-demand treatment with Human-cl rhFVIII
    To assess:
    3. Median prophylactic dosing interval
    4. Human-cl rhFVIII consumption data
    5. PK of Human-cl rhFVIII in terms of FVIII:C
    6. Safety of Human-cl rhFVIII

    Additional objectives:
    To assess:
    1. Thrombin generation assay (TGA) in terms of its usefulness in individualizing therapy for patients on prophylaxis
    2. Clinical efficacy of Human-cl rhFVIII in the treatment of breakthrough bleeding episodes (BEs)
    3. Clinical efficacy of Human-cl rhFVIII in surgical prophylaxis
    4. Correlation of vWF antigen concentration and half-life of Human-cl rhFVIII
    1.Összehasonlítani az egyénileg beállított profilaxisú betegek egy évre eső spontán vérzéseinek arányát olyan betegek kórtörténetében feltüntetett vérzéses események arányával, akik szükség szerint kaptak kezelést Human-cl rhFVIII-ral.
    2.Összehasonlítani az egy évre eső spontán vérzések arányát az egyénileg heti kétszeri (vagy kevesebb) adagra beállított profilaxisú betegeknél a kórtörténetben feltüntetett vérzéses események arányával olyan betegeknél, akik szükség szerint kaptak kezelést Human-cl rhFVIII-ral.
    3.Értékelni a median profilaktikus kezelések között eltelt időtartamot.
    4.Értékelni a Human-cl rhFVIII felhasználás adatait
    5.Vizsgálni a FVIII:C arányra vonatkoztatott Human-cl rhFVIII PK-t
    6.Értékelni a Human-cl rhFVIII biztonságosságát
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (a) Severe haemophilia A (FVIII:C < 1%) according to medical history
    (b) Male patients ≥ 18 years of age
    (c) Previous treatment with a FVIII concentrate (regular prophylaxis with good compliance or on-demand treatment) for at least 150 EDs
    (d) Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start
    (e) Immunocompetence (CD4+ count > 200/μL)
    (f) HIV-negative according to medical history; if positive, viral load < 200 particles/μL or < 400,000 copies/mL
    (g) Freely given written informed consent
    (a)Súlyos hemofília A (FVIII:C < 1%) a kórtörténet alapján
    (b)18 éves, vagy idősebb férfi betegek
    (c)Korábban legalább 150 alkalommal kezelték valamilyen FVIII koncentrátummal (rendszeres profilaktikus kezelés, jól együttműkő beteg, vagy kezelés szükség szerint))
    (d)A vizsgálat kezdete előtti 6 hónapban jól dokumentált a gyógyszer adagolása és a vérzés gyakorisága.
    (e)Immunkompetencia (CD4+ szám> 200/µl)
    (f)A kórtörténet szerint HIV-negatív; ha pedig pozitív, a vírusterhelés < 200 részecske/µl, vagy < 400,000 kópia/ml
    (g)Önkéntesen adott, írásos Beleegyező nyilatkozat
    E.4Principal exclusion criteria
    (a) Any coagulation disorder other than haemophilia A
    (b) Present or past FVIII inhibitor activity (≥ 0.6 BU) according to medical history
    (c) Severe liver or kidney disease (ALT and AST levels > 5 times of upper limit of normal, creatinine > 120 μmol/L)
    (d) Treatment with any investigational medicinal product (IMP) except FVIII IMP within 14 days prior to the screening visit
    (a)Ha a hemofília A betegségen kívül más véralvadási zavar is fennáll
    (b)FVIII inhibitor aktivitás van, vagy volt (≥ 0.6 BU) a kórtörténet szerint
    (c)Súlyos máj-, vagy vesebetegség (ALT és AST szint a normál érték felső határának több mint 5-szöröse, kreatinin > 120 µmol/l)
    (d)Ha bármilyen vizsgálati készítménnyel (IMP) történik kezelés, kivéve, ha azFVIII IMP a szűrővizitet megelőző 14 napon belül
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of the annualized total bleeding rate observed in the GENA-01 study (58.1 total bleeding episodes per patient per year) by 50% during individually tailored prophylaxis
    A GENA-01vizsgálatban megfigyelt, egy évre eső összes vérzéses események arányának (58.1 összes vérzés/beteg/év) 50%-os csökkenése az egyénileg beállított profilaxis ideje alatt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study
    A vizsgálat végén.
    E.5.2Secondary end point(s)
    1. Reduction of the annualized spontaneous bleeding rate observed in the GENA-
    01study (38.5 spontaneous bleeding episodes per patient per year) by 50% during individually tailored prophylaxis
    2. Reduction of the annualized bleeding rate observed in GENA-01 by 50% in patients with 2x/week prophylaxis or less
    3. Median prophylactic dosing interval during individually tailored prophylaxis
    4. Human-cl rhFVIII consumption data (FVIII IU/kg per month per patient) during
    individually tailored prophylaxis
    5. Safety and tolerability of Human-cl rhFVIII by monitoring adverse events (AEs)
    throughout the study
    1.A GENA-01vizsgálatban megfigyelt, egy évre eső spontán vérzéses események arányának (38.5 spontán vérzés/beteg/év) 50%-os csökkenése az egyénileg beállított profilaxis ideje alatt.
    2.A GENA-01vizsgálatban megfigyelt, egy évre eső vérzéses események arányának 50%-os csökkenése olyan betegeknél, akik heti 2, vagy kevesebb profilaktikus kezelést kaptak.
    3.A profilaktikus adagolás medianja az egyénileg beállított profilaxis ideje alatt
    4.A Human-cl rhFVIII felhasználási adatai (a havi, betegenkénti FVIII NE/kg az egyénileg beállított profilaxis ideje alatt)
    5.A Human-cl rhFVIII biztonságossága és tolerálhatósága a nemkívánatos esmények (AEk) figyelésével a teljes vizsgálat ideje alatt
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be evaluated at the end of the study with the exception of the 5th secondary endpoint, Safety and tolerability of Human-cl rhFVIII by monitoring adverse events (AEs), which will take place throughout the study
    Minden másodlagos végpont értékelve lesz a vizsgálat végén, az 5. másodlagos végpont kivételével, a Human-cl rhFVIII biztonságossága és tolerálhatósága a nemkívánatos események (AEk) figyelésével a teljes vizsgálat alatt.
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 55
    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)
    At the end of the study, patients will continue substitution therapy using a commercially available FVIII product, e.g., the one they had used prior to study enrolment, as per the investigator’s judgment.
    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 Decision2013-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-16
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