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    Summary
    EudraCT Number:2006-006277-24
    Sponsor's Protocol Code Number:EFC6145
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-07-17
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-006277-24
    A.3Full title of the trial
    A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED PARALLEL GROUP
    STUDY OF THE EFFICACY AND SAFETY OF 4 ADMINISTRATIONS OF
    XRP0038/NV1FGF 4mg AT 2–WEEK INTERVALS ON AMPUTATION OR ANY DEATH
    IN CRITICAL LIMB ISCHEMIA PATIENTS WITH SKIN LESIONS
    A.4.1Sponsor's protocol code numberEFC6145
    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 et 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.3.1Product nameNV1FGF
    D.3.2Product code XRP0038
    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 IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.1CAS number Not assigned
    D.3.9.2Current sponsor codeXRP0038
    D.3.9.3Other descriptive nameNV1FGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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 Yes
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Critical Limb Ischemia with skin lesions
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10058069
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate the superiority
    of 4 administrations of XRP0038/NV1FGF 4mg at 2-week intervals
    over placebo in the prevention of major amputation above the ankle
    of the treated leg or of death from any cause, whichever comes first,
    in critical limb ischemia (CLI) patients with skin lesions.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate:
    -The efficacy of XRP0038/NV1FGF versus XRP0038/NV1FGF placebo for delaying the time to major amputation.
    -The efficacy of XRP0038/NV1FGF versus XRP0038/NV1FGF
    placebo for delaying the time to death.
    -The safety of XRP0038/NV1FGF in the study population
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    TRANSCUTANEOUS OXYGEN PRESSURE (TcP02) SUBSTUDY, version 2.0, date 25 April 2007.

    The objective of this substudy is to properly measure the oxygen pressure in few patients in order to see if XRP0038/NV1FGF will improve the tissue oxygenation via the new vessel induced by angiogenesis.
    This substudy will be performed only at selected sites specified in such measures.

    EFC6145 Wound Substudy protocol, version 2.0 dated 23 May 2008:

    The objective of the wound assessment substudy is to assess the effect of 4 administrations of XRP0038/NV1FGF 4mg at 2 weeks interval versus placebo on wound healing in CLI patients.
    E.3Principal inclusion criteria
    Patients complying with the following criteria will be eligible for inclusion:
    1. Aged > 50 years old
    2. Having CLI with skin lesions (either ulcer(s) stable over the last 2 week interval or gangrene ie major tissue loss).
    3. With objective evidence of CLI such as ankle systolic pressure less than 70 mmHg and/or toe systolic pressure less than 50 mmHg or TcPO2 less than 30 mm Hg and peripheral arterial flow assessed preferably by angiography, magnetic resonance or CT angiography (or by Doppler ultra sonography if the documentation of an older angiography technique is available), in the 6 months prior to first study treatment administartion.
    4. Unsuitable for standard revascularization of his/her peripheral arterial disease (patient will be considered unsuitable for revascularization by a vascular surgeon when there is no good or lack of autologous material for grafting, or if there is an unfavorable anatomy, or a bad prognosis of the revascularization, such as the revascularization will only bring an incomplete perfusion of the foot, or if there will be at high risk of failure/amputation, or if there is a safety risk associated with the revascularization procedure).
    5. Having a negative screening for cancer (including a complete physical examination of each system organs especially the skin but other than ischemic skin lesions, a haematology blood test, a chest X-ray, a stool hemoccult test and in the last 6 months prior to screening a measurement of the level of Prostate Specific Antigen for males, a mammography and a Pap test for females. Additional investigations may be required as per local guidelines for cancer screening or because of a family cancer history or high frequency of a cancer in a country).
    6. Who have signed the informed consent.
    E.4Principal exclusion criteria
    1. Previous major amputation on the leg to be treated.
    2. Planned major amputation within the first month following randomization.
    3. Infected gangrene involving the forefoot evidenced by imaging (Xray).
    4. Known Buerger’s disease.
    5. Venous ulcer.
    6. Successful lower extremity revascularization surgery (bypass or angioplasty of the leg to be treated, sympathicolysis, sympathectomy or neurostimulation) within 3 months prior to randomization.
    7. Uncontrolled blood pressure defined as SBP > 180 mmHg or DBP >110 mmHg despite adequate antihypertensive treatment.
    8. Presence of a severe non cardiovascular co-morbid condition such that the patient is not expected to survive more than 12 months.
    9. Acute cardiovascular events (myocardial infarctus (MI), stroke, recent coronary intervention) within 3 months prior to randomization.
    10. Active/proliferative retinopathy or severe macular oedema.
    11. Previous or current history of malignant disease, other than basal cell carcinoma and cervical carcinoma in situ, within the past 5 years. Previous malignant disease of more than 5 years with relapse or therapy within the 5 past years.
    12. Previous treatment with systemic growth angiogenic factors or stem cells therapy.
    13. Geographical or social factors that may preclude appropriate compliance to study
    requirements (e.g.: patients living too far from investigational site).
    14. Pregnant or breast-feeding woman or woman of childbearing potential not protected by effective contraceptive method of birth control.
    15. Receipt of any investigational treatment (drug or device) within the previous 30 days.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is major amputation of the treated leg or death from any cause, whichever comes first, over the 12 months study period.
    Major amputation is an amputation above the ankle.
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    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 years4
    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 years4
    E.8.9.2In all countries concerned by the trial months7
    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 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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 204
    F.4.2.2In the whole clinical trial 490
    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 Decision2007-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-08
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