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    Summary
    EudraCT Number:2007-007947-28
    Sponsor's Protocol Code Number:EFC10636
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-10
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2007-007947-28
    A.3Full title of the trial
    A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with placebo for the Extended Prevention of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery
    A.3.2Name or abbreviated title of the trial where available
    SAVE-HIP3
    A.4.1Sponsor's protocol code numberEFC10636
    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 Sponsorsanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    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.3.2Product code AVE5026
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAVE5026
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.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.3.2Product code AVE5026
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeAVE5026
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The subjects who will participate to this clinical trial are patients having undergone hip fracture surgery.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049909
    E.1.2Term Venous thromboembolism prophylaxis
    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 efficacy of once daily (q.d.) subcutaneous (sc) injections of 20 mg AVE5026 (10 mg in patients with severe renal insufficiency [SRI]) with placebo during 3 additional weeks following an initial 7 to 10 days of open-label venous thromboprophylaxis with q.d. sc injections of 20 mg AVE5026 (10 mg in patients with SRI) for the prevention of venous thromboembolic events (VTE), i.e. deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in patients having undergone hip fracture surgery.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of extended AVE5026 prevention in patients having undergone hip fracture surgery.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients can be enrolled in the run-in phase only if they satisfy the following selection criteria for enrollment (ENR):
    - ENR1. Standard surgery for fracture of the upper third of the femur, including femoral head and neck with incision closure performed 8±1 hours previously, and provided that hemostasis has been established,
    - ENR2. Signed written informed consent.

    Patients can be randomized at the end of the run-in phase only if they satisfy the following selection criteria for randomization:
    - R1. Patients who completed the run-in phase without permanent discontinuation of AVE5026 prevention,
    - R2. And still complying with the selection criteria of the run-in phase.
    E.4Principal exclusion criteria
    - Exclusion criteria related to study methodology:
    1. Legal lower age limitations (country specific)
    2. Estimated time of injury/fracture before hospital admission > 24 hours
    3. Time from hospital admission to surgery > 36 hours*
    * If time from injury to hospital admission is documented to be less than 24 hours, this 36 hours time window can be expanded but in all cases the time from injury to surgery must not exceed 60 hours.
    3A1. Multiple trauma affecting more than one organ system
    4. Any major orthopedic surgery within 3 months prior to enrollment
    5. Hemorrhagic stroke or recent (less than 3 months prior to enrollment) brain, spinal or ophtalmological surgery
    6. Active or recent (<3 months) significant bleeding, including gastro-intestinal bleeding
    7. Hemostasis prior to the first AVE5026 injection of the run-in phase, not established
    8. Clinical signs or symptoms of DVT or PE within the last 12 months or known post-phlebitic syndrome
    9. Known sensitivity to iodine or contrast dyes, and any contraindication to the performance of venography
    10. Any treatment within 2 weeks prior to enrollment in the run-in phase or planned during the course of the run-in phase and double-blind treatment phase, that could affect the incidence of VTE such as:
    •Parenteral anticoagulants (UFH, LMWH [e.g. enoxaparin, dalteparin, nadroparin,…],
    fondaparinux, bivalirudin, hirudin)
    •Oral anticoagulants (e.g. vitamin K antagonists,...)
    •GPIIb/IIIa antagonists: abciximab, eptifibatide, tirofiban
    •Thrombolytic agents
    •Dextrans
    •Intermittent pneumatic compression
    *Note: Chronic treatment with antiplatelet agents such as low-dose aspirin (up to 325 mg/day), clopidogrel or ticlopidine in patients with coronary artery disease is allowed
    10A1. Patient with sigificant loss of mobility prior to fracture or with any severe medical conditions requiring a prolonged venous thromboprophylaxis according to the investigator`s judgment
    11. Known progressive malignant disease
    12. Subject unlikely to comply with protocol (e.g. uncooperative attitude, inability to return for follow-up visits, inability to receive daily injection by a Health Care Professional) after hospital discharge and unlikelihood of completing the study
    13. Treatment with any Investigational Product or investigational device in the last 30 days or 5 half lives (whichever is longer, if relevant) prior to enrollment/randomization
    14. Any previous exposure to AVE5026 (e.g. participation in any previous AVE5026 clinical trial)
    *Note: A patient may not be enrolled in the run-in phase or randomized for the double-blind treatment phase of the study more than once
    15. Refusal or inability to give informed consent to participate in the study

    - Exclusion criteria related to AVE5026:
    16. History of heparin-induced thrombocytopenia
    17. Know hypersensitivity to UFH or LMWH
    18. End stage renal disease (estimated creatinine clearance <10 mL/min [see Appendix B]) or patient on dialysis
    19. Pregnant or breast-feeding women
    20. Women of childbearing potential not protected by effective contraceptive method of birth control as defined for contraception in the Informed Consent Form for the duration of the study and/or who are unwilling or unable to be tested for pregnancy.
    *Note: Pregnancy status should be checked by serum or urine pregnancy testing prior to exposure to the open-label or investigational product.

    - Exclusion criteria related to the run-in phase (to be checked before randomization):
    21. Occurrence of exclusion criteria (1 to 20)
    22. Withdrawal of consent
    23. Permanent discontinuation of AVE5026 during the run-in phase.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is a composite of any VTE confirmed by a blinded Central Independent Adjudication Committee (CIAC) and deaths from any cause reported during the efficacy evaluation period. The efficacy evaluation period lasts from the randomization up to the day of the mandatory bilateral venography, or up to Day 24, whichever comes first.
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 Yes
    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 years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    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 Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 505
    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 Decision2008-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-22
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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