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    Summary
    EudraCT Number:2012-003276-39
    Sponsor's Protocol Code Number:09072012
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-08-29
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-003276-39
    A.3Full title of the trial
    Investigation of the value of Iron and Bonemarrow stimulation in differential diagnostic of Polycythemia Vera and Essential Thrombocytosis
    Jern- og Knoglemarvsstimulationstest i Differentialdiagnosen mellem Polycytæmia Vera og Essentiel Trombocytose


    En Klinisk Pilotundersøgelse af Patienter under Udredning for
    Polycytæmia Vera og Essential Trombocytose

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the value of bonemarrow stimulation in the diagnostic proces of patients with excess red/white bloodcells and platelets.
    Undersøgelse af værdien af stimulering af knoglemarven i udredningen af patienter med for mange blodceller (røde, hvide/blodplader).

    A.4.1Sponsor's protocol code number09072012
    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 SponsorHæmatologisk afdeling, Roskilde Sygehus, Region Sjælland
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegion Sjælland
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Sjælland
    B.5.2Functional name of contact pointHæmatologisk Afdeling
    B.5.3 Address:
    B.5.3.1Street AddressKøgevej 7-13
    B.5.3.2Town/ cityRoskilde
    B.5.3.3Post code4000
    B.5.3.4CountryDenmark
    B.5.6E-mailhkhl@regionsjaelland.dk
    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 Ferro Duretter
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Smith Kline
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameferro duretter
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.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 Neupogen
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameNeupogen
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    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) 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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Polycythemia Vera
    Essential thrombocytosis
    Polycythemia Vera
    Essential thrombocytosis
    E.1.1.1Medical condition in easily understood language
    Excess red blood cells
    Excess platelets
    For mange røde blodlegemer
    For amnge blodplader
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level HLGT
    E.1.2Classification code 10022958
    E.1.2Term Iron and trace metal metabolism disorders
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level HLT
    E.1.2Classification code 10029355
    E.1.2Term Neutropenias
    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
    1. To evaluate the diagnostic value of iron stimulation in differential diagnostic of JAK2V617F-positive and JAK2617F-negativ ET.

    2. to evaluate the capacity to mobilise neutrofil cells in patients refered with high blood count and high number of platelets
    FORMÅL
    Primary
    1. At vurdere værdien af jernsubstitution i differentialdiagnosen mellem JAK2V617F-positiv og JAK2617F-negativ ET.

    2. At vurdere neutrofi¬locytmobiliseringskapaciteten hos patienter henvist til udredning af høj hæmatokrit/PV og ET

    E.2.2Secondary objectives of the trial
    Secundary
    1. To evaluate the relationship between neutrofil cell mobilisation capacity and JAK2-V617F- mutation level as assesed by quantitativ PCR-tecnique in full blood before and after rhG-CSF in patients with PV, ET and secundary polycythemia.

    2. To investigate the correlation between the expression of alkaline phosphatase in granulocytes and JAK2V617F mutation burden before and after rhG-CSF in patients with PV, ET and secondary polycythemia.

    3. To describe gene expression (full blood) before and after G-CSF stimulation in patients with ET, secondary polyglobuli and PV.

    4. To describe the marker profile determined by flow cytometry on peripheral blood before and after the G-CSF stimulation.

    Sekundære
    1. At undersøge sammenhængen mellem neutrofilocytmobiliseringskapacitet og JAK2-V617F- mutationsbyrden bedømt ved kvantitativ PCR-teknik på ”fuldblod” før og efter rhG-CSF hos patienter med PV, ET og sekundær polycytæmi.

    2. At undersøge sammenhængen mellem ekspressionen af alkalisk fosfatase i granulocytter og JAK2V617F-mutationsbyrden før og efter rhG-CSF hos patienter med PV, ET og sekundær polycytæmi.

    3. At beskrive genekspressionsprofilen (fuld blod) før og efter G-CSF-stimulation hos patienter med ET, sekundær polyglobuli og PV.

    4. At beskrive markørprofilen ud fra flowcytometri på perifert blod før og efter G-CSF stimulation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    1.Age> 18 years.
    2.No cytoreductive therapy
    Inklusionskriterier:
    1. Alder > 18 år.
    2. Ingen cytoreduktiv behandling
    E.4Principal exclusion criteria
    1. Pregnant women.
    2. No Patient acceptance.
    1. Gravide kvinder.
    2. Manglende patientaccept.

    E.5 End points
    E.5.1Primary end point(s)
    Ensure proper early diagnosis of myeloproliferative neoplasms
    Sikre en korrekt tidlig diagnostik af de myeloproliferative neoplasier
    E.5.1.1Timepoint(s) of evaluation of this end point
    In 3 years 2015
    Om 3 år 2015
    E.5.2Secondary end point(s)
    A certain separation of the disease entities will have great therapeutic impact because patients with early myelofibrosis probably will be treated early with interferon-alpha2 in the near future.
    En sikker adskillelse af sygdomsenhederne vil at få stor terapeutisk konsekvens, idet patienter med tidlig myelofibrose formentlig fremover vil blive tidligt behandlet med interferon-alpha2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    In three years 2015
    Om 3 år 2015
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    Reaching the number of participants specified as fifty
    Opnåelse af antallet af forsøgspersoner angivet til halvtreds
    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 months
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    none
    Ingen
    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 Decision2012-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-09
    P. End of Trial
    P.End of Trial StatusOngoing
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