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    Summary
    EudraCT Number:2008-001589-94
    Sponsor's Protocol Code Number:2007-192
    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:2008-05-14
    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 number2008-001589-94
    A.3Full title of the trial
    En randomiseret, placebo-kontrolleret, dobbelt-blind afprøvning af intravenøs immunglobulin til kvinder med uforklarlig sekundær abortus habitualis
    A.4.1Sponsor's protocol code number2007-192
    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 SponsorRigshospitalet
    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 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 Immunglobulin CSL Behring 120mg/ml infusionsvæske, opløsning
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring GmbH
    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 nameImmunglobulin CSL Behring, infusionsvæske, opløsning
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous 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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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 placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    sekundær abortus habitualis defineret som 3 eller flere spontanaborter efter en fødsel og mindst 4 spontanaborter ialt.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018807
    E.1.2Term Habitual aborter, currently pregnant, unspecified as to episode of care
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Undersøge om frekvensen af levendefødsel hos patienter med sekundær abortus habitualis, der behandles med aktiv forsøgsmedicin (intravenøs immunglobulin) i graviditeten er højere end den tilsvarende frekvens hos patienter behandlet med placebo (humant albumin) uden eksklusioner af nogen art.
    E.2.2Secondary objectives of the trial
    Undersøge om frekvensen af levendefødsel hos patienter med sekundær abortus habitualis, der behandles med aktiv forsøgsmedicin i gravditeten er højere end den tilsvarende frekvens hos patienter behandlet med placebo efter eksklusioener af graviditeter med kromosomabnorme fostre, ekstrauterine graviditer og patienter som ikke gennemfører behandlingerne.

    Undersøge om perinatale parametre såsom fødselsvægt, Apgarscore etc. adskiller sig mellem børn født af forsøgspersoner behandlet med IvIg i forhold til placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    4 eller flere bekræftede spontanaborter før udgangen af 14 graviditetsuge hos en kvinde som tidligere har gennemført en eller flere graviditeter til mindst 28. graviditetsuge med efterfølgende fødsel af et levende eller dødfødt barn. Mindst 3 af graviditeterne skal have været konsekutive efter sidste fødsel og have den aktuelle partner som fader.
    E.4Principal exclusion criteria
    1) Alder mindre end 18 eller over 41 år ved opstået graviditet
    2) Betydende uterine anomalier
    3) Betydende kromsomanomali hos parret
    4) Menstruationscyklus < 23 dage eller > 35 dage
    5) Fund af lupusantikoagulans eller IgG anticadiolipinantistofkoncentration >=40 GPL kU/l eller plasma-homocystein >= 25 mikrogram/l ved gentagne målinger før graviditeten.
    6) Positiv test for HIV eller hepatitis B eller C bærertilstand
    7) IgA-mangel
    8) Tilstedeværelse af kroniske sygdomme som nødvendiggør konstant indtagelse af antiinflammatorisk elelr potentielt gravidtetsskadelig medicin såsom korticosteroider, acetylsalicylsyre, indometacin, simvastatin eller imurel. Der må ikke være planlagt antikoaguationsbehandling fra begyndelsen af graviditeten
    9) Graviditet opstået ved brug af donorsæd eller donoræg.
    10) 3 eller flere af de forudgående gravditetstab har udelukkende været dokumenteret ved en positiv graviditetstest (biokemisk graviditet)
    11) Graviditet hvor der er planlagt administration af gestagener eller østrogener efter påvisning af graviditeten
    12) 3 eller flere tidligere IVF/ICSI/FER forsøg uden efterfølgende graviditet eller afsluttet med biokemisk graviditet eller spontanabort
    13) Tidligere deltagelse i forsøget
    E.5 End points
    E.5.1Primary end point(s)
    Fødsel af et barn som overlever neonatalperioden 4 uger efter fødslen
    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 No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    Sidste fødsel eller spontanabort hos en forsøgsperson indicerer afslutningen af forsøget og allokeringskoderne kan derefter brydes.
    Sidste patients sidste besøg i forsøget forventes at blive i november 2010
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    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) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    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 state82
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 82
    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)
    I protokollen
    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 Decision2008-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-25
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