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    Summary
    EudraCT Number:2012-005770-57
    Sponsor's Protocol Code Number:version121219
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-12-27
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-005770-57
    A.3Full title of the trial
    Clinical effect of Atenativ treatment on uterine blood flow and the amount of Atenativ needed to maintain a normal antithrombin level during two weeks in early and severe preeclampsia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical effect of antithrombin concentrate treatment on uterine blood flow and the amount of Atenativ needed to maintain a normal antithrombin level during two weeks in early and severe preeclampsia
    A.4.1Sponsor's protocol code numberversion121219
    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 Sponsordepartment of OBstetrics, Sahlgrenska university hospital
    B.1.3.4CountrySweden
    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 supportOctapharma
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationdepartment of Obstetrics, Gothenburg
    B.5.2Functional name of contact pointMargareta Hellgren
    B.5.3 Address:
    B.5.3.1Street AddressSmörslottsgatan
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code41685
    B.5.3.4CountrySweden
    B.5.6E-mailmargareta.hellgren@vgregion.se
    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 Atenativ ( antithrombin concentrate)
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Concentrate and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous 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 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 Yes
    D.3.11.13.1Other medicinal product typeplasma concentrate of human origin
    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
    Early and severe preeclampsia with low antithrombin activity.
    Tidigt debuterande och svår havandeskapsförgiftning med låg antitrombin aktivitet.
    E.1.1.1Medical condition in easily understood language
    Women with early, severe preeclampsia and low antithrombin activity, an important inhibitor of blood coagulation, is a complication with hypertension, proteinuri and increased risk of prematurity.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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
    To study blood flow in uterine artery duirng infusion of Atenativ and to study how myck Atenativ has to be administered to maintain normal antithrombin activity during two weeks.
    E.2.2Secondary objectives of the trial
    Secondary the outcome of pregnancy and neonatal status will be studied.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women with severe early-onset preeclampsia during gestational week 23-29+0.
    2. Severe preeclampsia as defined by international criteria (1,2)
    • Blood pressure >160/110 mmHg (measured twice 30 minutes apart).
    proteinuria (>5 .0 g/L per 24 hours or >3 + labstick in at least two random
    samples six hours apart) after 20th gestational week.
    • Blood pressure >140/90 mmHg and proteinuria >5.0 g/24 h.
    • preeclampsia ( blood pressure > 140/90 and proteinuria >0.3 g/24 h) with IUGR or subjective symptoms as epigastic pain (HELLP), headache, dizziness or visual disturbancies, oligouri < 600 ml/24 h, coagulation disturbancies.
    3. AT level <0.8 kIE/LC

    E.4Principal exclusion criteria
    1. History of congenital AT deficiency
    2. Severe preeclampsia with demand on acute delivery within 24 hours according to the investigators judgement
    3. Concomitant administration of anticoagulants and platelet inhibitors within 2 weeks
    4. Chronic renal disease
    5. Diabetes melittus or gestational diabetes
    6. Intrauterine fetal death
    7. Participation in another clinical study
    8. Multiple pregnancies
    E.5 End points
    E.5.1Primary end point(s)
    Blood flow in a uterine artery during infusion of Atenativ

    Amount Atenativ needed to maitain normal antithrombin activity during twp weeks from inclusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During infusion of Atenativ
    E.5.2Secondary end point(s)
    Outcome of pregnancy and neonatal status
    E.5.2.1Timepoint(s) of evaluation of this end point
    After delivery
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 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
    2 months after the last patient´s delivery.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 6
    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 state6
    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)
    Women with preeclampsia and low antithrmbin activity will be treated according to routines depending om the level of antithrombin activity. This means antithrombin <0.8 kIU/L but >0.5 kIU/L thromboprophylaxis will be administered. If the antithrombin actvity is <0.5 kIU/L administration of antithrombin concentrate will be considered.
    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 Decision2013-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-26
    P. End of Trial
    P.End of Trial StatusOngoing
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