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    Summary
    EudraCT Number:2010-022884-36
    Sponsor's Protocol Code Number:EPOANE3021 (Epoetin alfa)
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-20
    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 ConcernedGreece - EOF
    A.2EudraCT number2010-022884-36
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Versus Placebo in Anemic Patients with IPSS Low- or intermediate 1 Risk Myelodysplastic Syndromes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy Study for Epoetin alfa in Anemic Patients with Myelodysplastic Syndromes
    A.4.1Sponsor's protocol code numberEPOANE3021 (Epoetin alfa)
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Medical Affairs, Turnhoutseweg 30, B-2340 Beerse
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV- Clinical Registry Group Archimdesweg 29
    B.5.3.2Town/ city2333CM Leiden
    B.5.3.4CountryNetherlands
    B.5.4Telephone number(+)31 (0)71 524 21 66
    B.5.5Fax number(+) 31 (0)71 524 21 10
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    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 EPREX
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG PHARMACEUTICAL SACI
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 nameEPOETIN ALFA
    D.3.2Product code EPO
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 ALFA
    D.3.9.1CAS number 113427-24-0
    D.3.9.4EV Substance CodeSUB06575MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40.000
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anemic Patients With IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes
    E.1.1.1Medical condition in easily understood language
    Anemic Patients With Myelodysplastic Syndromes
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10002272
    E.1.2Term Anemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that epoetin alfa treatment is better at improving anemia outcome (as evaluated by Erythroid response – International Working Group [IWG] 2006) in subjects with International Prognostic Scoring Systems (IPSS) Low- or Intermediate-1-risk myelodysplastic syndromes (MDS), compared with placebo, through Week 24.
    E.2.2Secondary objectives of the trial
    The secondary objectives include:
    - For responders at Week 24, observe the duration of the response through Week 48.
    - To assess the proportion of responders at Week 24 maintaining response through Week 48 (as measured by
    Erythroid response – IWG 2006).
    - To compare time to first RBC transfusion, transfusion-free intervals, and number of RBC units transfused.
    - To measure and compare changes in patient-reported outcome (PRO)/quality of life from baseline via the
    Functional Assessment of Cancer Therapy - Anemia/Fatigue (FACT-An) and EuroQol 5-dimension (EQ-5D)
    questionnaires.
    - To collect medical resource utilization data that may be used in future economic modeling (the construction and
    reporting of the economic model will be conducted separately from this study).
    Overall safety will also be assessed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject at least18 years of age;
    2. Diagnosis of MDS according to WHO or FAB pathologic classification (confirmed
    via bone marrow aspirate);
    3. Documentation of an IPSS score indicating Low- or Intermediate-1-risk disease;
    4. Hemoglobin concentration at screening and baseline (before the first dose of study
    drug) of 10.0 g/dL or less;
    Note: assessment should be based on untransfused hemoglobin, ie, the subject did
    not receive an RBC transfusion within the previous week.
    5. Screening serum erythropoietin concentration of less than 500 mU/mL;
    6. RBC transfusion requirement of less than 4 RBC units over the last 8 weeks before
    randomization;
    7. Screening Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;
    8. Adequate iron stores, defined as serum ferritin greater than 100 ng/mL, transferrin
    saturation greater than 20%, or both, measured within the 2-week screening period,
    or adequate iron stores as demonstrated by recent (within 12 weeks) bone marrow
    examination with iron stain;
    9. Documentation of adequate vitamin B12 and folate levels (above the lower limit of
    the reference range for the laboratory performing the assay), measured at screening
    and baseline;
    10. Female subjects with reproductive potential must be surgically sterile, abstinent, or
    practicing an effective method of birth control (eg, prescription oral contraceptives,
    contraceptive injections, intrauterine device, double-barrier method [spermicidal
    jelly or foam with condoms or diaphragm], contraceptive patch, male partner
    sterilization) before entry and throughout the study and have a negative urine or
    serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening (all
    female subjects with reproductive potential) and at Week 24 (female subjects with
    reproductive potential continuing in the treatment extension phase);
    11. Willingness to adhere to the prohibitions and restrictions specified in this protocol;
    12. Subjects (or their legally acceptable representatives) must sign an informed consent
    document indicating that they understand the purpose of and procedures required for
    the study and are willing to participate in the study.
    E.4Principal exclusion criteria
    1. Anemia attributed to factors other than MDS (including hemolysis, chronic renal
    failure, hepatitis, gastrointestinal bleeding);
    2. Secondary MDS (ie, MDS arising after chemotherapy, immunotherapy or radiation
    therapy/exposure);
    3. Active malignancy within the past year, except basal cell or carcinoma in situ of the
    cervix or breast;
    4. Prior therapy with epoetin alfa or any other approved or experimental ESA
    (eg, epoetin beta, darbepoetin) for more than 8 weeks before randomization;
    5. Prior use of approved or experimental agents for the treatment of MDS;
    6. History (within 6 months) of DVT (including proximal and distal), pulmonary
    embolism, or other venous thrombosis;
    Note: prior superficial thrombophlebitis is not an exclusion criterion.
    7. Clinically significant, uncontrolled disease or dysfunction of the pulmonary,
    cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to MDS;
    8. Uncontrolled hypertension (defined as a systolic pressure of 160 mmHg or higher,
    or a diastolic pressure of 110 mmHg or higher, or both);
    9. Less than 2 weeks since prior androgens or corticosteroids for the treatment of
    MDS;
    10. Prior (within the previous 2 weeks) treatment with G-CSF or
    granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of
    neutropenia;
    Note: in case of neutropenic fever, use of these agents is not an exclusion criterion.
    11. Known history of human immunodeficiency virus (HIV) seropositivity;
    12. History (within 6 months) of cerebrovascular accident (including ischemic, embolic,
    and hemorrhagic cerebrovascular accident), transient ischemic attack, acute
    coronary syndrome (including myocardial ischemia, unstable angina, Q-wave
    myocardial infarction, non-Q-wave myocardial infarction), or other arterial
    thrombosis;
    13. Known history of inherited conditions that predispose the subject to thrombosis
    (eg, AT3 deficiency, Factor V Leiden);
    14. New-onset seizures (within 3 months before randomization) or poorly controlled
    seizures;
    15. Pregnancy or breastfeeding;
    16. Known hypersensitivity to mammalian cell-derived products or to human albumin;
    17. Use of experimental agents or devices for any reason within 4 weeks before
    randomization;
    18. Major infection requiring hospitalization and antibiotic use within 2 weeks before
    randomization;
    19. Major surgery within 4 weeks before randomization or planned major surgery
    during the study period;
    20. Planned stem cell harvest of bone marrow or high-dose chemotherapy with stem cell
    transplantation during the study period;
    21. Previous bone marrow or stem cell transplantation;
    22. History of PRCA and/or antibody against erythropoietin;
    23. Employee of the investigator or study center, with direct involvement in the
    proposed study or other studies under the direction of that investigator or study
    center and family members of the employees or the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of subjects at Week 24 with improved anemia outcome, defined as
    Erythroid response according to the IWG 2006 criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    - For responders at Week 24, the duration of the response through Week 48.
    - The proportion of responders at Week 24 maintaining response through Week 48 (as measured by Erythroid
    response – IWG 2006).
    -Time to first RBC transfusion, transfusion-free intervals, and number of RBC units transfused.
    - Change from baseline in PRO/quality of life (as assessed with the FACT-An and EQ-5D).
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 48
    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 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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA32
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Greece
    Italy
    Russian Federation
    Spain
    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 last subject
    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 months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 111
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Legal Representative
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 147
    F.4.2.2In the whole clinical trial 159
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No different than normal care
    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 Decision2011-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-07
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