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    Summary
    EudraCT Number:2010-023471-26
    Sponsor's Protocol Code Number:P-Monofer-CKD-03
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-18
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2010-023471-26
    A.3Full title of the trial
    A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison with Intravenous Iron Sucrose in Subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Et randomiseret, komparativt, ikke-blindt fase III-forsøg med intravenøst jernisomaltosid 1000 (Monofer®), indgivet som vedligeholdelsesbehandling med enkelte eller gentagne bolusinjektioner sammenlignet med intravenøst jernsukrose hos forsøgspersoner med kronisk nyresygdom i stadie 5, som er i dialyse.
    A.4.1Sponsor's protocol code numberP-Monofer-CKD-03
    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 SponsorPharmacosmos A/S
    B.1.3.4CountryDenmark
    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 supportPharmacosmos A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacosmos A/S
    B.5.2Functional name of contact pointClinical R&D
    B.5.3 Address:
    B.5.3.1Street AddressRoervangsvej 30
    B.5.3.2Town/ cityHolbaek
    B.5.3.3Post codeDK-4300
    B.5.3.4CountryDenmark
    B.5.4Telephone number04559485935
    B.5.5Fax number04559485960
    B.5.6E-mailllt@pharmacosmos.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 Monofer
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacosmos A/S
    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 nameMonofer
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIron isomaltoside 1000
    D.3.9.1CAS number 9004-66-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 RoleComparator
    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 Venofer
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA
    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 nameVenofer
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIron(III)-hydroxide sucrose complex
    D.3.9.1CAS number 8047-67-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.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
    Stage 5 Chronic Kidney Disease on Dialysis Threapy (CKD5D)
    Dialyseterapi krævende kronisk nyresygdom
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary 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 intravenous iron isomaltoside 1000 (Monofer®) is noninferior to IV iron sucrose determined as ability to maintain Hb in subjects with CKD5D who are on maintenance iron therapy.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To obtain safety reassurance with the use of iron isomaltoside 1000 (Monofer®) for the maintenance of Haemoglobin in subjects with CKD-5D who are on maintenance iron therapy
    • To evaluate the safety of intravenous iron isomaltoside 1000 (Monofer®) in comparison with iron sucrose administered intravenously in patients with CKD-5D
    • To compare iron related hematological parameters (haemoglobin (Hb), Transferrin Saturation (TfS), serum iron, serum ferritin levels and reticulocyte count)
    • To assess subjects who discontinue study due to lack of response or intolerance
    • Assess changes in Quality of Life (QoL) by Linear Analog Scale Assessment (LASA)
    • Assess Restless Legs Syndrome (RLS) symptoms and change in these symptoms during the study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects with a diagnosis of CKD-5D, in dialysis therapy for at least 90 days prior to inclusion, will be
    included if they meet all of the following criteria:
    1. Men or women, aged 18 years or greater.
    2. Subjects diagnosed with CKD-5D and in haemodialysis therapy for at least 90 days.
    3. Life expectancy beyond 12 months by Principal Investigator’s judgement.
    4. Willingness and ability to participate after Informed Consent.
    5. Hb concentrations between 10.0 g/dL and 12.5 g/dL (both values included) both at screening
    Visit 1a and at Screening Visit 1b. (Screening Visit 1a and Visit 1b must be separated by at
    least 1 week).
    6. Serum ferritin < 800 ng/mL.
    7. Transferrin Saturation < 35%.
    8. Subjects receiving ESA treatment with dose stable for the previous 4 weeks prior to inclusion
    (with only 1 missed dose to be allowed. Does to be kept stable during the study period).
    9. Subjects receiving no IV iron or an average of no more than 100 mg/week for the previous 4
    weeks (with only 1 missed dose to be allowed. Does to be kept stable during the study
    period).
    Forsøgspersoner, som er diagnosticeret med CKD-5D, og som har været i dialyse i mindst 90 dage inden inklusion, inkluderes, hvis de opfylder følgende kriterier:
    1. Mænd og kvinder over 18 år.
    2. Forsøgspersoner, som er diagnosticeret med CKD-5D, og som har været i hæmodialyse i mindst 90 dage.
    3. Forventet levetid over 12 måneder efter den forsøgsansvarlige investigators vurdering
    4. Forsøgspersonen er villig og i stand til at deltage efter afgivelse af informeret samtykke.
    5. Hb-koncentrationer mellem 10,0 g/dl og 12,5 g/dl (inklusiv begge værdier) både ved screeningsbesøg 1a og 1b. (Der skal gå mindst 1 uge mellem screeningsbesøg 1a og 1b).
    6. Serumferritin < 800 ng/ml.
    7. Transferrinmætning < 35 %.
    8. Forsøgspersoner, som har fået ESA-behandling ved stabil dosis i de sidste 4 uger inden screening (det er kun tilladt at have undladt at tage 1 dosis. Dosen skal være stabil gennem studiet).
    9. Forsøgspersoner, som ikke har fået intravenøst jern eller gennemsnitligt højst 100 mg/uge i de sidste 4 uger (det er kun tilladt at have undladt at tage 1 dosis. Dosen skal være stabil gennem studiet).
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    1. Anaemia caused primarily by factors other than renal related anaemia.
    2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and
    haemosiderosis).
    3. Patients currently undergoing treatment with immunosuppresives (low dose steroids are
    allowed during the study conduct for dosages no more than 10 mg prednisolone/day or
    equivalent. If possible the dosage should be kept constant through the study).
    4. Difference of Hb 1.0 g/dL between screening Visits 1a and 1b.
    5. Patients with a history of multiple allergies.
    6. Decompensated liver cirrhosis or active hepatitis [Alanine Aminotransferase (ALT) > 3 times
    normal] or history of Hepatitis B or C.
    7. Active acute or chronic infections (assessed by clinical judgement), supplied with White Blood
    Cells (WBC) and C-Reactive Protein (CRP).
    8. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
    9. Pregnancy or nursing. (To avoid pregnancy, women have to be postmenopausal (at least 12
    months must have elapsed since last menstruation), surgically sterile, or women of child
    bearing potential must use one of the following contraceptives during the whole study period
    and after the study has ended for at least 5 times plasma biological half-life of the
    investigational medicinal product: Contraceptive pills, Intrauterine Devices (IUD),
    contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal
    ring, and transdermal patches).
    10. Blood transfusion within the previous 12 weeks.
    11. Planned elective surgery in the next 8 weeks.
    12. Participation in any other clinical trial within the past 30 days, or if longer, where the study
    drug has not passed five half-lives prior to screening.
    13. Untreated Vitamin B12 or folate deficiency.
    14. Any other medical condition that, in the opinion of Principal Investigator, may cause the
    subject to be unsuitable for the completion of the study or place the subject at potential risk
    from being in the study. Examples include Uncontrolled Hypertension, Unstable Ischemic
    Heart Disease or Uncontrolled Diabetes Mellitus.
    Personer, der opfylder et eller flere af følgende kriterier, er uegnede til inklusion i forsøget:
    1. Anæmi forårsaget primært af andre faktorer end nyrerelateret anæmi.
    2. Jernoverbelastning eller forstyrrelser i jernudnyttelsen (f.eks. hæmokromatose og hæmosiderose).
    3. Patienter, som aktuelt behandles med immunosuppresiva. (lav dosis steroider er tilladte gennem studiet, hvis dosis svarer til højest 10 mg prednisolone/dag eller ækvivalent. Hvis det er muligt, skal dosis være stabil gennem studiet).
    4. Forskel på Hb ≥ 1,0 g/dl mellem screeningsbesøg 1a og 1b.
    5. Multiple allergier i anamnesen.
    6. Dekompenseret levercirrhose eller aktiv hepatitis [alaninaminotransferase (ALT) > 3 x normalværdien] eller hepatitis B eller C i anamnesen.
    7. Aktive akutte eller kroniske infektioner (vurderet ved klinisk skøn), understøttet af leukocyttal (WBC) og C-reaktivt protein (CRP).
    8. Rheumatoid arthritis med symptomer eller tegn på aktiv ledinflammation.
    9. Patienten er gravid eller ammer. (For at udelukke graviditet skal kvinder være postmenopausale (mindst 12 måneder siden sidste menstruation) eller steriliseret eller, for fødedygtige kvinder, anvende en af følgende antikonceptionsmetoder i hele forsøgsperioden og i en periode efter forsøgets afslutning svarende til mindst 5 biologiske plasmahalveringstider af forsøgslægemidlet: P-piller, spiral, parenteral antikonception med depotvirkning (depotpræparat med gestagen), subdermalt implantat, vaginalring eller depotplastre).
    10. Blodtransfusion inden for de sidste 12 uger.
    11. Planlagt elektiv operation inden for de næste 8 uger.
    12. Deltagelse i et andet klinisk forsøg inden for de sidste 30 dage eller i et tidsrum inden screeningen svarende til mindre end 5 halveringstider af det pågældende forsøgslægemiddel.
    13. Ubehandlet B12-vitamin- eller folatmangel.
    14. Enhver anden medicinsk tilstand, som efter den forsøgsansvarlige investigators skøn kan gøre forsøgspersonen uegnet til gennemførelse af forsøget eller udsætte forsøgspersonen for en potentiel risiko ved deltagelse. Som eksempler kan nævnes: ukontrolleret hypertension, ustabil iskæmisk hjertesygdom og ukontrolleret diabetes mellitus.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is:
    1. Proportion of patients able to maintain haemoglobin between 10 and 12.5 g/dl (both values
    included) at week 6.
    Forsøgets primære endpoint er:
    1. Andel af patienter som kan opretholde et hæmoglobin niveau mellem 10 og 12.5 g/dl (inklusiv begge værdier) til uge 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 6
    Uge 6
    E.5.2Secondary end point(s)
    The secondary end points of the study are:
    1. Change in Hb concentration from baseline to week 2, 4, and 6.
    2. Safety laboratory assessments at baseline and 1, 2, 4 and 6 weeks.
    3. Change in concentrations of serum iron, TfS, serum ferritin and reticulocyte count from
    baseline to week 1, 2, 4 and 6.
    4. Number of subjects in each randomization group who discontinue study because of lack of
    response or intolerance of investigational drugs.
    5. Change in total QoL score (LASA) from baseline to week 4 and 6.
    6. Change in RLS symptoms (CH-RLSq score) from baseline to week 6 in subjects with RLS
    symptoms at baseline.
    7. Number of subjects who experience any Adverse Drug Reaction (ADR) including any
    Suspected Unexpected Serious Adverse Reaction (SUSAR).
    De sekundære endpoints er:
    1. Ændring i Hb-koncentration fra baseline til uge 2, 4 og 6.
    2. Sikkerhedsmæssige laboratorievurderinger ved baseline og efter 1, 2, 4 og 6 uger.
    3. Ændring i koncentrationen af serumjern, TfS, serumferritin og retikulocytter fra baseline til uge 1, 2, 4 og 6.
    4. Antallet af forsøgspersoner i hver randomiseringsgruppe, som udtræder af forsøget på grund af manglende respons eller intolerance over for forsøgslægemidlerne.
    5. Ændring i total QoL-score (LASA) fra baseline til uge 4 og 6.
    6. Ændring i RLS-symptoner (CH-RLS-score) fra baseline til uge 6 hos forsøgspersoner med RLS-symptomer ved baseline.
    7. Antal forsøgspersoner, som får uønskede lægemiddelreaktioner, herunder uventede og alvorlige formodede lægemiddelreaktioner (SUSAR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. from baseline to week 2, 4 and 6.
    2. from baseline and 1, 2, 4 and 6 weeks.
    3. from baseline to week 1, 2, 4 and 6.
    5. from baseline to week 4 and 6.
    6. from baseline to week 6
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Denmark
    India
    Sweden
    Switzerland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 the last subject expected 1 November 2012
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 350
    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)
    After the end of the study or if subject is withdrawn from the study, the subject will be treated according to standard hospital practice.
    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 Decision2011-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-28
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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