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    Summary
    EudraCT Number:2008-003960-20
    Sponsor's Protocol Code Number:NN7008-3543
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-14
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-003960-20
    A.3Full title of the trial
    A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects with
    Haemophilia A
    Sub-Trial:
    Safety and Efficacy of N8 in Prevention and Treatment of Bleeding during Surgical Procedures in Subjects with Haemophilia A
    A.4.1Sponsor's protocol code numberNN7008-3543
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameN8
    D.3.2Product code NN7008
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNN8
    D.3.9.2Current sponsor codeNN7008
    D.3.9.3Other descriptive nameRecombinant Factor VIII
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Haemophilia A
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018937
    E.1.2Term Haemophilia A
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective of Part A , Part B
    To assess the incidence rate of FVIII inhibitors (≥0.6 BU/mL)
    E.2.2Secondary objectives of the trial
    Secondary Objectives of Part A and Part B
    • To evaluate the clinical efficacy of N8 in bleeding prevention in subjects with haemophilia A.
    • To evaluate the clinical efficacy of N8 when treating bleeds in subjects with haemophilia A.
    • To evaluate the safety of N8 when used for prevention of bleeding episodes and treatment of mild, moderate, and severe bleeds in subjects with haemophilia A
    • To assess changes in Patient Reported Outcomes (PROs) from screening to end of trial
    • Part A only: To describe and compare the PK profile of N8 in the subjects who participated in both this trial and NN7008-3522.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Part C:
    Safety and Efficacy of N8 in Prevention and Treatment of Bleeding during Surgical Procedures in Subjects with Haemophilia A

    Date: 29 Jan 2010
    Version: 10

    Primary Objective of Part C
    To assess the incidence rate of FVIII inhibitors (≥0.6 BU/mL)

    Secondary Objectives of Part C
    • To evaluate the efficacy of N8 during surgical procedures in subjects with haemophilia A
    • To evaluate the haemostatic response to N8 in the post-surgery period for subjects with haemophilia A
    • To evaluate the safety of N8 when used for prevention and treatment of bleeding during surgical procedures and in the surgery period in subjects with haemophilia A
    • To assess changes in PROs from pre-surgery to last day of recovery
    E.3Principal inclusion criteria
    Part A
    1. Completion of the phase 1 PK trial NN7008-3522
    2. Informed consent obtained prior to any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
    3. Male subjects with the diagnosis of severe (FVIII≤1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial ) to 56 years having a weight of 10 to 120 kg.
    4. Willing to undergo a bleeding preventative treatment of 75 dose days
    5. Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product for measurement of recovery in relation to administration of the first dose and the PK session
    6. Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds) (Please refer to section 8.6.2.3)
    7. No history of FVIII inhibitors ≥0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A (Please refer to section 8.6.2.2)
    8. No detectable inhibitors to FVIII (≥0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)
    9. Not in use
    10. Not in use
    11. HIV-1 seronegative or if HIV-1 seropositive, viral load < 400.000 copies/mL and CD4+ lymphocyte count ≥200/μL.
    Subjects who have completed NN7008-3522 have already met inclusion criteria no 1-3 and 5-11 in NN7008-3522.
    Part B
    1. Informed consent obtained prior to any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
    2. Male subjects with the diagnosis of severe (FVIII≤1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial and 18 for all subjects in Croatia) to 65 years having a weight of 10 (20 in Brazil) to 120 kg.
    3. Willing to undergo a bleeding preventative treatment of 75 dose days
    4. Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product for measurement of recovery in relation to administration of the first dose (please refer to section 8.2.2)
    5. Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds) (Please refer to section 8.6.2.3)
    6. No prior history of FVIII inhibitors. Documentation should be available for at least the last 8 years (or since treatment with FVIII products started if shorter than 8 years), please refer to Section 8.6.2.2)for required documentation
    7. No detectable inhibitors to FVIII (≥0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)
    8. Not in use
    9. Not in use
    10. HIV-1 seronegative or if HIV-1 seropositive, HIV viral load < 400.000 copies/mL and CD4+ lymphocyte count ≥200/μL.
    Eligibility Criteria for Part C
    1. Undergo major or minor surgical procedures (Please refer to section 8.2.8)
    2. Surgical procedure requiring at least 7 days of infusion of N8 post-operatively
    Subjects will only participate in Part C when they have been included in either Part A or Part B and have received at least one dose of trial product (N8). Subjects can be recruited into part C when at least 5 subjects have each been treated with N8 for a bleeding episode and 80% of these subjects have a response rated excellent or good on the four–point haemostatic response scale for their first bleeding episode.
    E.4Principal exclusion criteria
    Exclusion Criteria for Part A and Part B
    1. Subjects receiving Immune modulating medication or Tolerance Induction (ITI) regimens
    2. Factor replacement treatment of a mild or moderate bleeding episode within 3 days prior to first dose (only applicable for subjects in Part B)
    3. Factor replacement treatment of a severe bleeding episode within one week prior to first dose (only applicable for subjects in Part B)
    4. Known pseudo-tumours
    5. Platelet count <50,000 platelets/μL based on medical records and/or based on local laboratory values at trial entry
    6. Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
    7. ALT > 4 times the upper limit of normal reference range (as defined by central laboratory ranges) (only for subjects in Part A)
    8. Febrile illness within 5 days prior to the first trial product administration and PK dosing
    9. Current dialysis therapy
    10. Creatinine levels 50% above normal level (as defined by central laboratory range)
    11. Congenital or acquired coagulation disorders other than haemophilia A
    12. Previous arterial thrombotic events (Myocardial Infarction and Intra Cranial Thrombosis) (as defined by medical records).
    13. Known or suspected allergy to trial product (N8) or related products
    14. Surgery within one month prior to first administration of trial product (catheter, stents, ports, and dental extractions do not count as surgeries, i.e. they will not exclude the subject)
    15. Use of Coagulation Factors other than N8: Commercial FVIII concentrates or other FVIII containing products within 48 hours prior to first administration of trial product for recovery assessment. (not applicable for Part A subjects 1-3)
    16. Use of Anticoagulants: Heparin, vitamin-K antagonists, and direct thrombin inhibitors one week prior to first administration of trial product
    17. Not in use
    18. Not in use
    19. Use of platelet inhibitors including NSAID one week prior to first administration of trial product (only for subjects in Part A)
    20. The receipt of any investigational drug within 30 days prior to administration of trial product except subjects who have completed NN7008-3522 (for Brazil within one year prior to screening for this trial, unless there, in the investigators opinion, is a direct benefit to the research subject)
    21. Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522 after administration of trial product
    22. Any disease or condition which, according to the Investigator’s judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome
    23. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint for Part A, Part B and Part C
    • The incidence rate of Factor VIII inhibitors (≥0.6 BU/mL)
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    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 40
    F.4.2.2In the whole clinical trial 140
    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 Decision2009-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-21
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