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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-007862-39
    Sponsor's Protocol Code Number:BE1116_3003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-09-21
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2007-007862-39
    A.3Full title of the trial
    A open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of BERIPLEX® P/N compared with plasma for rapid reversal of coagulopathy induced by coumarin derivatives in subjects requiring emergency surgery or invasive intervention.
    A.4.1Sponsor's protocol code numberBE1116_3003
    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 SponsorCSL Behring GmbH
    B.1.3.4CountryGermany
    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 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 Beriplex® P/N
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring 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.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 9001267
    D.3.9.2Current sponsor codeHuman coagulation factor II
    D.3.9.3Other descriptive nameFACTOR II (PROTHROMBIN)
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 48
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 9001256
    D.3.9.2Current sponsor codeHuman coagulation factor VII
    D.3.9.3Other descriptive nameFACTOR VII (PROCONVERTIN)
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000079756
    D.3.9.2Current sponsor codeHuman coagulation factor IX
    D.3.9.3Other descriptive nameFACTOR IX
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 31
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 9001290
    D.3.9.2Current sponsor codeHuman coagulation factor X
    D.3.9.3Other descriptive nameFACTOR X (STUART PROWER FACTOR)
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number22 to 60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000050513
    D.3.9.2Current sponsor codeProtein C
    D.3.9.3Other descriptive namePROTEIN C (COAGULATION INHIBITOR)
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 45
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeProtein S
    D.3.9.3Other descriptive nameProtein S
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number13 to 26
    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) No
    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.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 No
    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 namePlasma
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000041078
    D.3.9.2Current sponsor codePlasma
    D.3.9.3Other descriptive namePLASMA
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 15
    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) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Perioperative prophylaxis for emergency surgery or invasive intervention in subjects who have an acquired deficiency of vitamin K-dependent coagulation factors and proteins C and S due to use of oral anticoagulation.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009789
    E.1.2Term Coagulation factors decreased
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10065667
    E.1.2Term Haemorrhage prophylaxis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the hemostatic efficacy of Beriplex® P/N and plasma in preventing excessive hemorrhages during emergency surgical or invasive interventions in subjects who have a deficiency of vitamin K-dependent coagulation factors II, VII, IX, X and proteins C and S acquired from oral anticoagulation.

    CO-PRIMARY OBJECTIVE
    To compare efficacy of Beriplex® P/N and plasma in rapidly reducing pre-operative international normalized ratio (INR) values between the 2 treatment groups at 30 minutes after end of infusion.
    E.2.2Secondary objectives of the trial
    -To compare the plasma levels of coagulation factors II, VII, IX, and X, protein C, and protein S between the 2 treatment groups
    -To document the time from start of infusion until INR correction for both treatment groups
    -To document the time from randomization until INR correction for both treatment groups
    -To compare INR between the 2 treatment groups at 30 minutes from start of infusion,
    -To compare the use of non-study prescribed blood products, additional FFP and/or hemostatic agents for coagulation in both treatment groups,
    - To compare predicted estimated blood loss versus actual estimated blood loss for intended procedure between the 2 treatment groups,
    - To compare the transfusion requirement intraoperatively and during the 24 hours from start of infusion,
    -To compare the volume and duration of wound drainage,
    - To determine the safety and tolerability of Beriplex® P/N compared to that of plasma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female subjects ≥ 18 years
    - Subjects who have received oral inticoagulation therapy (e.g. warfarin, acenocoumarol or phenprocoumon) and in whom either an emergency surgical or an invasive intervention is indicated. Due to the nature of the procedure, withdrawal of anticoagulation therapy and plasma are also indicated,
    - INR ≥ 2 within 3 hours before start of study treatment
    - Informed consent has been obtained
    E.4Principal exclusion criteria
    - Subjects with emergency surgical procedures in which according to the surgeon's clinical judgment, an accurate estimate of blood loss is not possible (e.g. ruptured aneurysm),
    - Administration of intravenous vitamin K more than 3 hours or administration of oral vitamin K more than 6 hours prior to infusion of study treatment,
    - Expected survival of less than 3 days,
    - Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control an acute bleeding complication and/or control the acute bleeeding event,
    - History of thrombotic event, myocardial infarction, unstable angina pectoris, cerebral vascular accident, transient ischemic attack, severe peripheral vascular disease, disseminated intravascular coagulation within 3 months of enrollment.
    - Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies,
    - Suspected or confirmed sepsis at time of enrollment
    - A previous thromboembolic event within 30 days prior to inclusion into the study
    - Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into study
    NOTE: Administration of packed red blood cells is not an exclusion criterion
    - Pre-existing progressive fatal disease with a life expectancy of less than 2 months
    - Known inhibitors to coagulation factors II, VII, IX, or X; or hereditary protein C or protein S deficiency; or heparin-induced, type II thrombocytopenia
    - Treatment with any other investigational medicinal product within 30 days prior to inclusion into the study,
    - Presence or history of hypersensitivity to components of the study medication
    - Pregnant or brest-feeding women
    - Prior inclusion in this study or any other CSL Behring sponsored Beriplex study,
    - For subjects with intracranial hemorrhage with:
    - Glasgow Coma Score <10
    - Modified Rankin Score > 3 prior to ICH
    - Intracerebral hemorrhage
    - Epidural hematomas
    - Infratentorial hemorrhage
    - Subarachnoid hemorrhage (SAH) subjects with a Hunt and Hess Scale >2
    - Subdural hematomas that: are judged to be an acute subdural hematoma (based on neurosurgeon review) or have a concurrent SAH or parenchymal contusion
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the hemostatic efficacy with respect to the adequacy of preventing excessive bleeding during surgical or invasive intervention (the "procedure"). The primary efficacy endpoint will be assessed immediately after the surgery or procedure. the assessment covers the entire period from the start of infusion to immediately after the surgery or procedure. The assessment includes the clinical signs and symptoms of the subject, laboratory values such as INR and any additional hemostatic treatments. The efficacy of only the planned study treatment and intended procedure should be assessed.
    The adequacy of preparing the subject for the surgery or procedure and prevention of excessive bleeding during the surgery or procedure will be rated by data and safety monitoring board (DSMB) and treating physician as excellent, good, or poor/none, based on pre-specified definitions.

    CO-PRIMARY EFFICACY VARIABLE
    The co-primary efficacy variable wil be the proportion of subjects who have a rapid decrease of the INR (i.e. INR ≤ 1.3) at 30 minutes after end of infusion.
    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 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 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 Yes
    E.8.2.3.1Comparator description
    Plasma
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the study is defined as the date of the last visit (end of viral safety follow-up) of the last subject undergoing the study.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) Yes
    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 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 No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 50
    F.4.2.2In the whole clinical trial 176
    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 Decision2010-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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