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    Summary
    EudraCT Number:2005-000347-29
    Sponsor's Protocol Code Number:060201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-000347-29
    A.3Full title of the trial
    Advate Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (Advate rAHF–PFM): A Phase 4 Study Comparing Two Prophylactic Regimens In Subjects With Severe Or Moderately Severe Hemophilia A.
    A.3.2Name or abbreviated title of the trial where available
    ADVATE: A Phase IV Prophylactic Study
    A.4.1Sponsor's protocol code number060201
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorBAXTER AG
    B.1.3.4CountryAustria
    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 Yes
    D.2.1.1.1Trade name Antihemophilic factor (Recombinant), Plasma/Albumin-free Method (ADVATE rAHF-PFm)
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter AG
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.4Pharmaceutical 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 INNCoagulation factor VIII
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    Pazients with severe or moderatly severe hemophilia A (baseline factor VIII < or =2% of normal)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10061992
    E.1.2Term Haemophilia
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To compare the rate of bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 hours) with that alternate prophylaxis (20-80 IU/kg every 72 hours) 2. To compare the rate of bleeding between the on-demand regimen and the prophylactic regimens 3. To compare the weight-adjusted consumption of ADVATE rAHF-PFM between the 2 prophylactic regimens 4. To determine the efficacy of ADVATE rAHF-PFM for the control of bleeding episodes throughout the study
    E.2.2Secondary objectives of the trial
    5. To determine the pharmacokinetic parameters for ADVATE rAHF-PFM utilizing at least 3 lots of the study product 6. To determine the immunogenicity of ADVATE rAHF-PFM 7. To determine the safety and toxicity of ADVATE rAHF-PFM 8. To determine differences in HRQoL between the 2 prophylaxis regimens and changes between the on-demand treatment and prophylactic regimens
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.The subject or the subject`s legally authorized representative has provided written IC 2.the subject has severe or moderately severe hemophilia A as defined by a baseline factor VIII level < or = 2% of normal, as tested at screening 3. the subject has a documented history of at least 150 exposure days to factor VIII concentrates. 4. The subject is within 7 to 65 years of age. 5.the subject has a Karnofsky performance score >60 6.the subject is HIV- or is HIV+ with a CD4 count> or = 400 cells/mm3 7.The subject has been under the care of the study site for at least 24 months prior to enrollment 8.the subject has been on a documented on-demand treatment regimen for at least 12 months immediately prior to enrollment. 9. the subject has a documented history of at least 12 joint hemorrhages in the 12 months immediately prior to enrollment. 10. the subject resides within the coverage area of the mobile compliance device, coverage area will be determined at screening.
    E.4Principal exclusion criteria
    1.the subject has a known hypersensitivity to factor VIII concentrates or mouse or hamster proteins 2.The subject has an history of factor VIII inhibitors with a titer > or = 0.6 BU at any time prior to screening. 3.the subject has a detectable factor VIII inhibitor at screening with a titer > or = 0,4 BU in the central laboratory. 4.the subject has severe chronic liver disease as evidenced by INR>1.4, hypoalbuminemia, portal vein hypertension and hystory of esophageal varices. 5.has been diagnosed with an inherited or aquired hemostatic defect other than hemophilia A (e. g. qualitative platelet defect or von Willebrand`s Disease) 6.the subject has been treated during the last 60 days prior to or is being treated at screening/enrollment with an immunomodulating drug. 7.has participated in another investigational study within 30 days of enrollment 8. has previously participated in a clinical study with ADVATE rAHF-PFM. 9.his/her clinical conditions may require a moderate or major surgery during the period of his/her participation in the study (estimated blood loss > or = 500 ml). 10.the subject is female of childbearing potential with a positive pregnancy test.
    E.5 End points
    E.5.1Primary end point(s)
    To compare the rate of bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 hours) with that alternate prophylaxis (20-80 IU/kg every 72 hours)
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    - same IMP used at different dosage
    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.8.6 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 months10
    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 months10
    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) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    pazienti affetti da emofilia A grave o moderatamente grave
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 66
    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 Decision2006-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-28
    P. End of Trial
    P.End of Trial StatusCompleted
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