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    Summary
    EudraCT Number:2008-002723-85
    Sponsor's Protocol Code Number:EPO-ANE-3018
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-01-08
    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 ConcernedCzechia - SUKL
    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.4.1Sponsor's protocol code numberEPO-ANE-3018
    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 N.V
    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 ®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag France ( Italy LOC for Italy)
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 INNEPOETINUM ALFA
    D.3.9.1CAS number 113427-24-0
    D.3.9.2Current sponsor codeRWJ-22512-000
    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) 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
    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.
    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 Yes
    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 IPSS Low or Intermediate 1 risk MDS who require any transfusion, compared with placebo, through Week 48.
    E.2.2Secondary objectives of the trial
    The secondary objectives include both efficacy and safety endpoints and are as follows:
    To compare the time to first transfusion after Day 28, the time to transfusion dependence, as defined by the 2006 IWG criteria after Day 28, the erythroid response rate using 2006 IWG criteria at Week 24 and Week 48, the cumulative number of RBC units transfused per subject through Weeks 24 and 48, 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 (see Attachment 7), AML, or death, the individual components of safety endpoints, including time to MDS progression (see Attachment 7), time to AML, and overall survival, progression free survival, the proportion of subjects with a TVE, the 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
    Subjects must satisfy the following criteria to be enrolled in the study:
    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 (β-hCG)
    pregnancy test at screening.
    14. Willingness to adhere to the prohibitions and restrictions specified in
    this protocol.
    15. 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.
    16. Subjects who agree to participate in DNA pharmacogenomic research
    (or their legally acceptable representatives) must sign an informed
    consent indicating willingness to participate in the pharmacogenomic
    component of the study, where local regulations permit. Refusal to
    consent for this component does not exclude a subject from
    participation in the clinical study.
    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.
    19. Major surgery within 4 weeks before randomization or planned major
    surgery before Week 52.
    20. Planned stem cell harvest of bone marrow or high-dose
    chemotherapy with stem cell transplantation before Week 52.
    21. Previous bone marrow or stem cell transplantation.
    22. Employees 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)
    Selection of a transfusion based variable as the primary endpoint reflects the currently accepted clinically meaningful outcome for registration studies of erythropoietic agents. 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 Yes
    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 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 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 years
    E.8.9.1In the Member State concerned months64
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months64
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-01-08. Yes
    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 state36
    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 Decision2009-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-11
    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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