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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2016-002649-41
    Sponsor's Protocol Code Number:LEX-209
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-02-13
    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 - PEI
    A.2EudraCT number2016-002649-41
    A.3Full title of the trial
    A Phase III, randomized, double-blind, multicenter study to assess the efficacy and safety of OCTAPLEX, a four-factor prothrombin complex concentrate (4F-PCC), compared to the 4F-PCC Beriplex® P/N (Kcentra), for the reversal of vitamin K antagonist induced anticoagulation in patients needing urgent surgery with significant bleeding risk.
    Eine randomisierte, doppelblinde, multizentrische Phase-III-Studie zur Untersuchung der Wirksamkeit und Sicherheit von OCTAPLEX, einem Prothrombinkomplex-Konzentrat mit 4 Faktoren (4F-PCC), im Vergleich zu 4F-PCC Beriplex® P/N (Kcentra) bezüglich der Aufhebung des gerinnungshemmenden Effekts durch Vitamin-K-Antagonisten bei Patienten mit dringlichem Operationsbedarf und signifikantem Blutungsrisiko.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III, randomized, double-blind, multicenter study to assess the efficacy and safety of OCTAPLEX, a four-factor prothrombin complex concentrate (4F-PCC), compared to the 4F-PCC Beriplex® P/N (Kcentra), for the reversal of vitamin K antagonist induced anticoagulation in patients needing urgent surgery with significant bleeding risk.
    Eine randomisierte, doppelblinde, multizentrische Phase-III-Studie zur Untersuchung der Wirksamkeit und Sicherheit von OCTAPLEX, einem Prothrombinkomplex-Konzentrat mit 4 Faktoren (4F-PCC), im Vergleich zu 4F-PCC Beriplex® P/N (Kcentra) bezüglich der Aufhebung des gerinnungshemmenden Effekts durch Vitamin-K-Antagonisten bei Patienten mit dringlichem Operationsbedarf und signifikantem Blutungsrisiko.
    A.4.1Sponsor's protocol code numberLEX-209
    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 SponsorOctapharma Pharmazeutika Produktionsges.m.b.H
    B.1.3.4CountryAustria
    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 supportOctapharma Pharmazeutika Produktionsges.m.b.H
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOctapharma Pharmazeutika Produktionsges.m.b.H
    B.5.2Functional name of contact pointClinical Research & Development
    B.5.3 Address:
    B.5.3.1Street AddressOberlaaer Strasse 235
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1100
    B.5.3.4CountryAustria
    B.5.4Telephone number+431610 321424
    B.5.5Fax number+431610 321249
    B.5.6E-maildmitrii.matveev@octapharma.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 Octaplex
    D.2.1.1.2Name of the Marketing Authorisation holderOCTAPHARMA 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 nameOctaplex
    D.3.4Pharmaceutical form Powder and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROTHROMBIN COMPLEX CONCENTRATE
    D.3.9.1CAS number 37224-63-8
    D.3.9.3Other descriptive namePROTHROMBIN COMPLEX CONCENTRATES
    D.3.9.4EV Substance CodeSUB33011
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    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 Beriplex
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring GmbH
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameBeriplex
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROTHROMBIN COMPLEX CONCENTRATE
    D.3.9.1CAS number 37224-63-8
    D.3.9.3Other descriptive namePROTHROMBIN COMPLEX CONCENTRATES
    D.3.9.4EV Substance CodeSUB33011
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    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
    Reversal of vitamin K antagonist (VKA) induced anticoagulation in patients needing urgent surgery associated with significant bleeding risk.
    E.1.1.1Medical condition in easily understood language
    Reversal of vitamin K antagonist (VKA) induced anticoagulation in patients needing urgent surgery associated with significant bleeding risk.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10065667
    E.1.2Term Haemorrhage prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under VKA therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to Beriplex® P/N (Kcentra).
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to investigate the safety and tolerability of OCTAPLEX compared to Beriplex® P/N (Kcentra) in patients under VKA therapy with the need for urgent surgery with significant bleeding risk.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients at least 18 years of age.
    2. Patients currently on oral anticoagulation treatment with VKA of coumadin or warfarin type.
    3. Patients being admitted to the hospital or currently hospitalized where:
    • an urgent surgery carrying significant bleeding risk (≥50 mL expected blood loss in normal coagulation state) is required as part of routine clinical care within 24 hours of the start of the investigational medicinal product;
    • VKA withdrawal and use of oral or parenteral vitamin K alone to reverse anticoagulation is deemed too slow or inappropriate for reversal;
    4. Patients with an INR of 2.0 or above at the time of decision to reverse the anticoagulation status.
    5. Patients who have given written informed consent and who are able and willing to comply with the procedures laid out in the study protocol.
    E.4Principal exclusion criteria
    1. Patients with a life expectancy of less than 48 hours per physician’s judgment (e.g., patients with a Glasgow Coma Scale equal to 3 or a head Abbreviated Injury Score of 6, patients requiring continuous inotropic or pressor support, and patients whose status is post cardiac arrest).
    2. Patients for whom the planned surgery or procedure is commonly associated with a very low bleeding risk (e.g., catheter placement, gastroscopy).
    3. Patients with a history of TEEs, myocardial infarction (MI), unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, TIA, severe peripheral vascular disease (e.g. Fontaine IV), or disseminated intravascular coagulation within 3 months of enrollment. (Note: ongoing thrombosis in-situ or severe unilateral peripheral arterial disease (PAD) undergoing surgical intervention is not an exclusion criterion).
    4. Patients with a known congenital bleeding disorder.
    5. Patients with a known antiphospholipid antibody syndrome.
    6. Patients with present or past specific factor inhibitor activity.
    7. Patients with thrombocytopenia of <80,000/μL or history of heparin-induced thrombocytopenia.
    8. Patients who have received more than 5000 units of systemic unfractionated heparin (UFH), any dose of low-molecular-weight heparin (LMWH) or any dose of non-VKA anticoagulant (i.e. direct oral anticoagulant) within 24 hours prior to enrollment into the study or have potential need to receive these medications in mentioned doses before completion of hemostasis evaluation at the end of surgery.
    9. Patients who have received PCCs, FFP or vitamin K within 72 hours prior to enrollment into the study.
    10. Patients receiving P2Y12 platelet inhibitors (e.g. Clopidogrel, Prasugrel, Ticagrelor)
    11. Patients with a known history of hypersensitivity to plasma-derived products.
    12. Patients requiring urgent surgical procedures where according to the surgeon's clinical judgment an accurate estimate of expected blood loss and transfusion requirements is not possible, e.g.:
    a. Surgeries requiring massive transfusion protocols (e.g., major polytrauma, major injuries, organ transplant surgeries),
    b. Patients with acute major bleeding (e.g. gastrointestinal bleeds, obstetric haemorrhage),
    c. Surgeries with unpredictable intraoperative blood loss (e.g., ruptured aneurysm, primary surgery for intracranial hemorrhage (ICH)).
    13. Pregnant or nursing women.
    14. Patients participating in another interventional clinical study currently or during the past 30 day prior to enrollment into this study.
    15. Patients previously enrolled in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the hemostatic efficacy rating at the end of the surgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of surgery.
    E.5.2Secondary end point(s)
    • Proportion of patients with an INR value of less than or equal to 1.5 at 30 min (± 15 min) after the end of infusion.
    • Change in coagulation factor levels from baseline to 30 (± 15 min) after the end of infusion:
    o Factor FII
    o Factor FVII
    o Factor FIX
    o Factor FX
    • Proportion of patients receiving red blood cells (RBC) during the surgery
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Proportion of patients with an INR value of less than or equal to 1.5 at 30 min (± 15 min) after the end of infusion.
    • Change in coagulation factor levels from baseline to 30 (± 15 min) after the end of infusion:
    o Factor FII
    o Factor FVII
    o Factor FIX
    o Factor FX
    • Proportion of patients receiving red blood cells (RBC) during the surgery
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Bulgaria
    Germany
    Poland
    Romania
    Russian Federation
    Spain
    Ukraine
    United States
    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
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    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: 222
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 148
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-02-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 222
    F.4.2.2In the whole clinical trial 370
    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 completion of the clinical trial patients will receive standard of care treatment in accordance with their standard medical care.
    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 Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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