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    Summary
    EudraCT Number:2006-001984-53
    Sponsor's Protocol Code Number:ETHIG II
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-19
    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 number2006-001984-53
    A.3Full title of the trial
    Effectiveness of Dalteparin Therapy as Intervention in recurrent pregnancy loss
    A.3.2Name or abbreviated title of the trial where available
    EHTIG II
    A.4.1Sponsor's protocol code numberETHIG II
    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 SponsorFriedrich-Schiller-Universität Jena
    B.1.3.4CountryGermany
    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 Fragmin P Forte
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Pharma GmbH
    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 nameFragmin P Forte
    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 INNDalteparine Sodium
    D.3.9.1CAS number 9041-08-1
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pregnant women with a history of recurrent pregnancy loss, defined as:

    - 2 or more early (< 12 weeks of gestation) pregnancy losses or
    - 1 or more late (> 12 weeks of gestation) pregnancy loss
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10036562
    E.1.2Term Pregnancy in habitual aborter
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Can the rate of pregnancy losses before the 24th week of gestation be reduced by dalteparin treatment?
    E.2.2Secondary objectives of the trial
    Can the rate of live births be increased by dalteparin treatment?
    Can the rate of late pregnancy complications (preterm delivery, placenta insufficiency, intrauterine growth retardation, preeclampsia and abruptio placentae) be reduced by dalteparin treatment?
    Description and comparison of the rate of foetal structural anomalies
    Description and comparison of symptomatic venous thrombembolic events during the pregnancy
    Description of the side effects of dalteparin (e.g. thrombocytopenia, osteoporosis, haemorrhage)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet ALL of the following criteria:

    Single pregnancy, 5th to 8th week of gestation
    Documented foetal heart activity in US
    History of recurrent pregnancy loss, defined as:
    -2 or more early (< 12 weeks of gestation) pregnancy losses or
    -1 or more late (> 12 weeks of gestation) pregnancy loss
    Age > 18 years
    Written informed consent of the patient
    E.4Principal exclusion criteria
    Patients will be excluded for ANY ONE of the following reasons:
    Previous pregnancy losses caused by foetal structural or chromosomal anomalies
    Uterine anomalies
    Maternal infection which caused previous pregnancy loss
    Risk group II or III according to ETHIG I risk stratification (clinical need for heparin prophylaxis)
    Acute thromboembolic event (need of heparin therapy)
    Known hypersensitivity to any of the trial drugs or its ingredients (i.e. thrombocytopenia type II caused by allergic reaction to heparin)
    Antiphospholipid antibody syndrome
    Diabetes mellitus
    Ongoing nicotine or drug or alcohol abuse
    HIV positive
    Expected low compliance (e.g. by travel distance to trial site)
    Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
    Injuries or surgeries of CNS, eyes or ear during the last 8 weeks prior to randomisation
    Active clinical significant bleeding (e.g. gastrointestinal, intracranial, intraocular) during the last 3 months prior to randomisation
    Diseases associated with enhanced predisposition of bleeding (e.g. hemorrhagic diathesis, deficiency of coagulation factors, severe affection of liver, kidney or pancreas, severe thrombocytopenia)
    Diseases caused by lesions of the vascular system (e.g. gastric, peptic or intestinal ulcer, hypertension (RR diast. > 105 mmHg, hemorrhagic apoplectic insult (3 month prior to randomisation), aneurysm of brain artery, retinopathies, bleeding of vitreous body, endocarditis lenta or septica)
    Renal and urethra calculi
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is ongoing intact pregnancy at 24 weeks of gestation.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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) No
    E.8.2.2Placebo No
    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 concerned12
    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 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
    End of the trial is defined as last follow-up visit after delivery of the last child of the last subject undergoing the trial

    In case of the following situations, a premature termination of the trial has to be considered:
    Serious adverse drug reactions leading to substantial changes in risk-benefit considerations
    Not justifiable toxicity
    Insufficient efficacy
    New insights from other trials
    Insufficient recruitment rate
    Unsustainable trial organization
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months2
    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) No
    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 No
    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 state446
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 486
    F.4.2.2In the whole clinical trial 486
    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)
    For patients randomized to dalteparin therapy, treatment ends at the 24th week of gestation, or in case of pregnancy loss before.
    Further treatment with dalteparin after the 24th week of gestation resp. after pregnancy loss is at the discretion of the investigator, according to the particular risk of the patient for a thromboembolic event.
    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 Decision2006-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-06
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