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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-000914-19
    Sponsor's Protocol Code Number:EPO-ANE-4008
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-07-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-000914-19
    A.3Full title of the trial
    A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.
    A.3.2Name or abbreviated title of the trial where available
    EPO-ANE-4008
    A.4.1Sponsor's protocol code numberEPO-ANE-4008
    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., Turnhoutseweg 30, 2340 Beerse, Belgium
    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 10,000 IU/ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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/ 10.000 IU/ml
    D.3.2Product code EPO
    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.3.11 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 typeglycoprotein
    D.IMP: 2
    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 40,000 IU/ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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/ 40.000 IU/ml
    D.3.2Product code EPO
    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.3.11 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 typeglycoprotein
    D.IMP: 3
    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 4,000 IU/ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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/ 4.000 IU/ml
    D.3.2Product code EPO
    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.3.11 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 typeglycoprotein
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anemia in cancer patients receiving chemotherapy

    MedDRA Version 5.1 : list of preferred terma used in the process of defining thrombotic vascular events, see investigators brochure epoetin alpha.
    MedDRA Classification
    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 compare the safety with respect to the incidence of clinically relevant and objectively confirmed TVEs in 2 dosing regimens of epoetin alfa when used following guidelines for baseline Hb (<=11 g/dL) and target Hb ( 12 g/dL) to treat anemia in subjects with nonmyeloid malignancies who are receiving chemotherapy.
    E.2.2Secondary objectives of the trial
    Seconday efficacy objectives include assessment of change in Hb, proportion of responders to epoetin alfa, and red blood cell (RBC) transfusion. Secondary safety objectives include rate of rise in Hb, time to clinically relevant and objectively confirmed TVE, and time to death. Overall safey including adverse events and clinical laboratory values will also be assessed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    " Men or women, 18 years of age or older
    " Any histologically confirmed nonmyeloid tumor at initial diagnosis
    " Day 1 baseline Hb d11 g/dL
    " Expected to receive at least 12 weeks of chemotherapy after enrollment
    into the study. For subjects receiving cyclic chemotherapy,
    randomization must be on the first day of a chemotherapy cycle. For
    subjects receiving non-cyclic chemotherapy, randomization may occur at
    any time during the chemotherapy.
    " ECOG performance status d2 (Attachment 3)
    " Life expectancy of >6 months, based on the clinical judgment of the
    investigator
    " Normal neutrophil count (>1.5 x 109/L) at start of initial chemotherapy
    " Normal platelet count (>100 x 109/L) at start of initial chemotherapy
    " Serum creatinine and bilirubin <1.5 times the upper limit of normal
    (ULN); aspartate aminotransferase (AST), alanine aminotransferase
    (ALT), alkaline phosphatase <3 times the ULN
    " TSAT e20%
    " Female subjects must be postmenopausal (for at least 1 year), surgically
    sterile, abstinent, or, if sexually active, be practicing an effective method
    of birth control (e.g., prescription oral contraceptives, contraceptive
    injections, intrauterine device, double-barrier method, contraceptive
    patch, male partner sterilization) before randomization; have a negative
    serum beta-human chorionic gonadotropin (²-hCG) pregnancy test
    within 2 weeks before randomization; and a negative urine pregnancy
    test at randomization.
    " Subjects (or their legally acceptable representatives) must have signed
    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
    " History of active second cancer except for adequately treated skin cancer
    and in situ cervical cancer
    " History of DVT or PE within 12 months before study entry or at any
    time if the event is related to the current cancer, which is defined as
    diagnosis of the cancer within 3 months of a DVT/PE episode or a
    DVT/PE following the cancer diagnosis/treatment. Prior superficial
    thrombophlebitis is not an exclusion criterion.
    " History of CVA, TIA, ACS, or other arterial thrombosis within 6 months
    before study entry. ACS includes unstable angina, QwMI, and NQMI
    " Onset of seizures within 3 months before randomization or poorly
    controlled seizures
    " Brain tumor or brain metastasis from another malignancy
    " Evidence of ischemic heart disease, New York Heart Association
    (NYHA) Class 3 to 4 cardiac disease (Attachment 4) or significant
    arrhythmias
    " Uncontrolled hypertension (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg)
    while receiving antihypertensive therapy or not on therapy
    " Anemia secondary to vitamin B12, folic acid, or iron deficiency
    " Anemia known to be secondary to gastrointestinal bleed, hemolysis
    (acquired or hereditary, e.g., sickle cell syndrome, thalassemia
    syndrome), PRCA, or primary myelodysplastic syndrome
    " Presence of other comorbid conditions or illnesses of the cardiovascular,
    respiratory, renal, or other body systems that would preclude
    administration of planned chemotherapy
    " Previous therapy with any marketed epoetin product within 2 months
    before randomization, lack of response to prior therapy with any epoetin
    product, or use of any investigational epoetin product at any time
    " Major surgery within 4 weeks before randomization or any preplanned
    surgery during the study
    " Current treatment with therapeutic or prophylactic anticoagulants. The
    only exceptions are low dose aspirin (d325 mg/d) in subjects with
    known cardiovascular disease or low dose anticoagulants to maintain
    patency of intravenous lines
    " Planned myeloablative chemotherapy with stem cell rescue or bone
    marrow transplant
    " Have received an experimental drug or used an experimental medical
    device within 3 months before the planned start of treatment.
    " Is pregnant or breast-feeding
    " Known hypersensitivity to epoetin alfa, or mammalian-cell derived
    products or formulation excipients
    " 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, as well as family members of the employees
    or the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects with at least 1 clinically
    relevant and objectively confirmed TVE from randomization through
    Week 16.
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    another dosing regimen of epoetin alfa
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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 years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 412
    F.4.2.2In the whole clinical trial 500
    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 Decision2006-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-07-30
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