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    Summary
    EudraCT Number:2006-002758-31
    Sponsor's Protocol Code Number:ECD01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-02
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2006-002758-31
    A.3Full title of the trial
    A randomized, double-blind, multi-centre, placebo-controlled, parallel-group study to examine the efficacy and safety of low dose Epoetin beta on wound healing in diabetes patients with foot ulcer
    A.4.1Sponsor's protocol code numberECD01
    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 SponsorEPOPLUS GmbH & Co.KG
    B.1.3.4CountryGermany
    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 NeoRecormon Multidose 50.000 I.E. Lyophilisat und Lösungsmittel zur Herstellung einer Injektionslösung (5.000 I.E./ml)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEpoetin beta
    D.3.9.3Other descriptive namerecombinant human erythropoietin
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50.000
    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 typerecombinant medicinal product
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    wound healing in diabetes patients with foot ulcer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10048037
    E.1.2Term Wound healing disturbance of
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effects of a systemic treatment with erythropoietin on wound closure in patients with diabetes and diabetic foot syndrome
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    a) To evaluate the wound healing, i.e. area of the target (biggest) ulcer, from baseline to week 13 (percentage and absolute change).

    b) To evaluate the microcirculation (only at selected study sites).

    c) To describe the one-year survival status/amputation rate/recurrence of target ulcer.
    d) To evaluate the wound healing, i.e. depth of the target ulcer from baseline to week 13.
    e) To evaluate the time to wound closure.
    f) To evaluate the reduction of pain.
    g) Safety and tolerability.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diabetic patients with foot ulcer below the ankle will be randomised into 2 treatment arms:
    a. diagnosis of diabetes and neuropathic ulcer Wagner I or II (as indicated by a neuropathy deficit score 6-10, palpable foot pulses and an ABI-index ≥1.0) or
    b. diagnosis of diabetes and ulcer Wagner I / II or wounds after amputations in patients with peripheral arterial occlusive disease (as indicated by the presence of one of the following: missing foot pulses and an ABI-index ≤0.8), or a history of insufficient vascularisation on the target leg*).
    *Angiographically documented peripheral arterial occlusive disease and no surgical or endovascular treatment option.

    2. Ulcer size over 0.5 cm2.
    3. Male or female aged ≥ 18 years.
    4. Signed written informed consent to participate in this trial.
    5. Female of childbearing potential with a negative pregnancy test, and agrees to use an acceptable contraceptive method (hormonal or IUD) throughout the study.
    6. HbA1c < 10% or, if > 10% then stable blood glucose level within the last 4 weeks, i.e. fasting blood glucose value < 160 mg/dl.
    7. At least one foot ulcer, the size of which can be documented using a transparent foil.
    8. Weight between 55 kg and 160 kg.

    9. Patients without significant healing after a 4 week Run-In period, can be randomized into a treatment arm.
    E.4Principal exclusion criteria
    1. Pregnant or nursing women.
    2. Myeloplastic or proliferative disease.
    3. Known infection with hepatitis B or hepatitis C or HIV.
    4. Therapy with rHuEPO or analogic medicine within the last 6 months.
    5. Bleeding episodes which affect the Hb value or known gastro-intestinale bleedings within the last 3 months.
    6. Known or suspected intolerance to erythropoetic factors, e.g. NeoRecormon®, Aranesp®, Erypo®.
    7. Treatment with systemic chemotherapy or radiotherapy or immunosuppressives or systemic corticosteroids within the last 6 months prior to treatment start.
    8. Previous therapy with growth factors, e.g. GM-CSF, VEGF in the last 6 months.
    9. Intake of any medication which interacts with epoetin beta (e.g. Cyclosporin).
    10. Uncontrolled systolic blood pressure > 160 mmHg (supine) and/or diastolic blood pressure > 100 mmHg.
    11. Pulmonary embolism and deep leg venous thrombosis with a history of venous thromboembolic disease.
    12. Stroke, instable angina pectoris, STEMI or NSTEMI within the last 3 month.
    13. Psychiatric disease or chronic cerebellar fits.
    14. Scheduled for vascular surgery or any other intervention surgery within 4 weeks to trial start or during the trial or patients, who could benefit from vascular surgery or other invasive intervention.
    15. Thromboembolism and/or thromboses.
    16. Atrial fibrillation or atrial septum defect.
    17. Transient ischaemic attack (TIA) within the last 3 month
    18. Prolonged reversible ischemic neurological deficit (PRIND) within the last 3 month
    19. Artificial heart valves (mechanical or biological)
    20. Alcohol or drug of abuse.
    21. Non-compliance and/or participation in a clinical trial within the last 3 months prior to screening.
    22. Patients in dialysis program or chronical renal failure Grad IV.
    23. Patients with known bleedings, MCV below normal ranges, and iron deficiency anemia
    24. Hemoglobin, hematocrit and platelet count above the upper limit of normal according to the local laboratory
    25. At the time point of randomization wound infections treated with antibiotics.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is complete wound closure of the target ulcer.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    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 Decision2006-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-24
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