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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2008-002723-85
    Sponsor's Protocol Code Number:EPO -ANE-3018
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-04-16
    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 number2008-002723-85
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Epoetin Alfa Initiated at 40,000 IU Every Week or 80,000 IU Every Week Versus Placebo in Subjects With IPSS Low- or Intermediate-1 Risk Myelodysplastic Syndromes at Risk for Transfusion
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberEPO -ANE-3018
    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 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 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 EPREX*1FL 40000UI/ML 1ML
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN CILAG SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNErythropoietin
    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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    IPSS Low or Intermediate 1 RISK Myelodysplastic Syndromes at risk for transfusion
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLT
    E.1.2Classification code 10028536
    E.1.2Term Myelodysplastic syndromes
    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 is to demonstrate that epoetin alfa treatment reduces the proportion of anemic subjects with International Prognostic Scoring Systems (IPSS) Low or Intermediate 1 risk myelodysplastic syndromes (MDS) who require any transfusion, compared with placebo, through Week 48.
    E.2.2Secondary objectives of the trial
    ·To compare the time to first transfusion after Day 28 ·To compare the time to transfusion dependence, as defined by the 2006 International Working Group (IWG) criteria after Day 28 ·To compare the erythroid response rate using 2006 IWG criteria at Week 24 and Week 48 ·To compare the cumulative number of red blood cell (RBC) units transfused per subject through Weeks 24 and 48 ·To confirm a lack of erythropoietin accumulation after treatment with epoetin alfa once every week for 48 weeks ·To assess the long-term safety of epoetin alfa treatment measured by a composite endpoint of time to MDS progression, acute myeloid leukemia (AML), or death ·To assess individual components of safety endpoints, including time to MDS progression, time to AML, or death ·To assess progression-free survival ·To assess the proportion of subjects having a thrombotic vascular event (TVE) ·Proportion of subjects whose disease progresses to AML by Week 52 and at the time of clinical cutoff.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female at least 18 years of age.
    2. Diagnosis of MDS according to WHO or FAB pathologic
    classification via bone marrow studies performed within 12 weeks
    before randomization.
    3. Documentation of an IPSS score indicating Low- or Intermediate-1
    risk disease, based on bone marrow studies, including cytogenetics
    and peripheral blood counts, performed within 12 weeks before
    randomization.
    4. Screening hemoglobin concentration of 10.0 g/dL or less. The
    screening hemoglobin concentration is defined as the average of at
    least 2 measurements taken at least 1 week apart during the 2-week
    period before randomization and not influenced by RBC transfusion
    (i.e., no RBC transfusions within 1 week before hemoglobin
    measurement).
    5. A baseline hemoglobin measurement collected within 24 hours prior
    to the first dose of study drug must measure 10.5 g/dL or less.
    6. Has not been transfusion dependent at any time during the previous
    6 months before randomization. A subject is considered to be
    transfusion dependent if he or she has received 4 or more RBC units
    for MDS-related anemia during a consecutive 8-week period
    (2006 IWG criteria).
    7. Baseline serum erythropoietin concentration of less than
    500 mU/mL.
    8. Adequate iron stores, defined as serum ferritin greater than
    100 ng/mL or transferrin saturation greater than 20% or both,
    measured within the 14-day 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), as measured within 12 weeks before randomization.
    10. Adequate hematologic function, defined as an absolute neutrophil
    count of at least 1,000/mm3 and a platelet count of at least
    50,000/mm3, not influenced by platelet transfusions within the
    previous 3 days.
    11. Life expectancy of at least 12 months (12 months or longer).
    12. ECOG performance status of 0, 1 or 2 (Attachment 4).
    13. Female subjects with reproductive potential must be surgically
    sterile, abstinent, or practicing an effective method of birth control
    (e.g., 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 serum or urine beta human chorionic gonadotropin (&amp;#946;-hCG)
    pregnancy test at screening.
    E.4Principal exclusion criteria
    1. Anemia attributed to factors other than MDS (including iron
    deficiency, vitamin B12 or folate deficiencies, hemolysis, chronic
    renal failure, or gastrointestinal bleeding).
    2. Secondary MDS (MDS arising after chemotherapy, immunotherapy
    or radiation therapy/exposure).
    3. Proliferative (WBC of at least 12,000/mm3) chronic myelomonocytic
    leukemia (CMML) or atypical chronic myelogenous leukemia
    (CML).
    4. Active malignancy within the past year except basal cell or squamous
    cell skin cancer or carcinoma in situ of the cervix or breast.
    5. Known history of HIV Type 1 seropositivity.
    6. History (within 12 months) of deep venous thrombosis (includes
    proximal and distal), pulmonary embolism, or other venous
    thrombosis. Prior superficial thrombophlebitis is not an exclusion
    criterion.
    7. History (within 6 months) of cerebrovascular accident (includes
    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.
    8. Currently receiving therapeutic anticoagulants (prophylactic
    anticoagulants are acceptable).
    9. Uncontrolled hypertension (defined as a systolic pressure of
    160 mmHg or higher or a diastolic pressure of 110 mmHg or higher
    or both).
    10. New onset seizures (within 3 months before randomization) or poorly
    controlled seizures.
    11. Clinically significant, uncontrolled disease or dysfunction of the
    pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or
    genitourinary systems not attributable to MDS.
    12. Pregnancy or breast feeding.
    13. Known hypersensitivity to mammalian-cell derived products or to
    human albumin.
    14. Prior or concurrent treatment with epoetin alfa or any other approved
    or experimental ESA (e.g., epoetin beta, darbepoetin), within the
    previous 12 months before randomization.
    15. Use of experimental agents or devices for any reason within the
    previous 8 weeks before randomization.
    16. Prior use of any approved or experimental agent for the treatment of
    MDS (e.g., cytotoxic chemotherapeutic agents, thalidomide,
    lenalidomide, tipifarnib, lonafarnib, azacitidine, decitabine, and
    danazole).
    17. Prior (within the previous 2 weeks) or concurrent treatment with
    G-CSF or granulocyte-macrophage colony-stimulating factor
    (GM-CSF) for the treatment of neutropenia.
    18. Major infection requiring hospitalization and antibiotics within
    2 weeks before randomization.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects who remain transfusion
    free from Day 29 through Week 48 was selected as the primary efficacy
    endpoint to account for the lag time between the start of erythropoietin
    treatment and its effect on hematopoiesis.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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.1.3Elderly (>=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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 450
    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 Decision2009-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-12-18
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