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    Summary
    EudraCT Number:2011-000413-39
    Sponsor's Protocol Code Number:251002
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-11
    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 number2011-000413-39
    A.3Full title of the trial
    BAX326 (recombinant Factor IX): A Phase 3 Prospective, Multicenter Stuy Evaluating Efficacy and Safety in Previously Treated Patients with Severe (FIX level < 1%) or Moderately Severe (FIX level ≤2%) Hemophilia B undergoing Surgical or Other Invasive Procedures.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BAX326 (recombinant Factor Nine): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients with Severe or Moderately Severe Hemophilia B undergoing Surgical or Other Invasive Procedures.
    A.3.2Name or abbreviated title of the trial where available
    BAX 326 Surgery
    A.4.1Sponsor's protocol code number251002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/293/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBaxter Innovations GmbH
    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 supportBaxter Innovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxter Innovations GmbH
    B.5.2Functional name of contact pointGuido Wuerth, Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressDonau City Strasse 7
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1220
    B.5.3.4CountryAustria
    B.5.4Telephone number+431201002473489
    B.5.5Fax number+431201002475727
    B.5.6E-mailguido_wuerth@baxter.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 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 nameRecombinant Coagulation Factor IX
    D.3.2Product code BAX 326
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNNONACOG GAMMA
    D.3.9.1CAS number 181054-95-5
    D.3.9.2Current sponsor codeBAX 326
    D.3.9.3Other descriptive nameRecombinant coagulation factor IX
    D.3.9.4EV Substance CodeSUB03451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Yes
    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 typeHuman Coagulation Factor IX (rDNA) produced by recombinant DNA technology in mammalian cell culture (CHO) INN: Nonacog gamma
    D.IMP: 2
    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 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 nameRecombinant Coagulation Factor IX
    D.3.2Product code BAX 326
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNNONACOG GAMMA
    D.3.9.1CAS number 181054-95-5
    D.3.9.2Current sponsor codeBAX 326
    D.3.9.3Other descriptive nameRecombinant coagulation factor IX
    D.3.9.4EV Substance CodeSUB03451MIG
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 typeHuman Coagulation Factor IX (rDNA) produced by recombinant DNA technology in mammalian cell culture (CHO) INN: Nonacog gamma
    D.IMP: 3
    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 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 nameRecombinant Coagulation Factor IX
    D.3.2Product code BAX 326
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNNONACOG GAMMA
    D.3.9.1CAS number 181054-95-5
    D.3.9.2Current sponsor codeBAX 326
    D.3.9.3Other descriptive nameRecombinant coagulation factor IX
    D.3.9.4EV Substance CodeSUB03451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Yes
    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 typeHuman Coagulation Factor IX (rDNA) produced by recombinant DNA technology in mammalian cell culture (CHO) INN: Nonacog gamma
    D.IMP: 4
    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 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 nameRecombinant Coagulation Factor IX
    D.3.2Product code BAX 326
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNNONACOG GAMMA
    D.3.9.1CAS number 181054-95-5
    D.3.9.2Current sponsor codeBAX 326
    D.3.9.3Other descriptive nameRecombinant coagulation factor IX
    D.3.9.4EV Substance CodeSUB03451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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 Yes
    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 typeHuman Coagulation Factor IX (rDNA) produced by recombinant DNA technology in mammalian cell culture (CHO) INN: Nonacog gamma
    D.IMP: 5
    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 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 nameRecombinant Coagulation Factor IX
    D.3.2Product code BAX 326
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    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 INNNONACOG GAMMA
    D.3.9.1CAS number 181054-95-5
    D.3.9.2Current sponsor codeBAX 326
    D.3.9.3Other descriptive nameRecombinant coagulation factor IX
    D.3.9.4EV Substance CodeSUB03451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3000
    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 Yes
    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 typeHuman Coagulation Factor IX (rDNA) produced by recombinant DNA technology in mammalian cell culture (CHO) INN: Nonacog gamma
    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
    Previously treated patients with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B undergoing surgical or other invasive procedures.
    E.1.1.1Medical condition in easily understood language
    Previously treated patients with severe or moderately severe hemophilia B undergoing surgical or other invasive procedures.
    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 17.0
    E.1.2Level LLT
    E.1.2Classification code 10018939
    E.1.2Term Haemophilia B (Factor IX)
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the hemostatic efficacy and safety of BAX 326 in the peri- and postoperative setting in subjects with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B undergoing major or minor elective or emergency surgical, dental or other invasive procedures.
    E.2.2Secondary objectives of the trial
    • To determine the actual intra- and postoperative blood loss at the end of surgery and until drain removal, if applicable, compared to the estimated volume of the expected average and maximum blood loss as predicted preoperatively by the operating surgeon
    • To determine the intra- and postoperative hemostatic efficacy at the end of the surgery, at the time of drain removal, if applicable, or at postoperative day 3 (approx. 72 h postoperatively) in case of major surgery and no drain employed, and at the time of discharge from the hospital on a scale of “excellent”, “good”, “fair” and “none”
    • To calculate the daily and total weight-adjusted dose of BAX 326 per subject
    • To record the number of units and amount of blood product use
    • To record the development of inhibitory and total binding antibodies to FIX
    • To determine AEs related to BAX 326
    • To determine the ocurrence of thrombotic events

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject is participating in either the BAX 326 Pivotal Study (#250901) or the BAX 326 Continuation Study (#251001) or the BAX326 Pediatric Study (#251101) requiring emergency or elective major or minor surgical, dental, or other invasive procedures
    a) Subject and/or legal representative has/have provided signed informed consent
    b) Subject continues to meet eligibility criteria as outlined in the BAX 326 pivotal, continuation, or pediatric study
    • For newly entering subjects who do not participate in any other BAX 326 clinical study the following inclusion criteria apply:
    a) Subject is 12 to 65 years old at the time of screening.
    b) Subject requires elective major surgery.
    c) Subject and/or legal representative has/have provided signed informed consent
    d) Subject has severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B (based on the one stage activated partial thromboplastin time (aPTT) assay), as tested at screening at the central laboratory.
    e) Subject is previously treated with plasma-derived and/or recombinant FIX concentrate(s) for a minimum of 150 EDs (based and documented on the subject’s medical records).
    f) Subject has no evidence of a history of FIX inhibitors (based on the subject’s medical records).
    g) Subject is immunocompetent as evidenced by a CD4 count ≥ 200 cells/mm3.
    h) Subject is human immunodeficiency (HIV) negative or is HIV+ with a viral load
    < 200 particles/μL ~ <400,000 copies/mL
    i) If female of childbearing potential, subject presents with a negative pregnancy test and agrees to employ adequate birth control measures for the duration of the study.
    j) Subject is willing and able to comply with the requirements of the protocol.
    E.4Principal exclusion criteria
    • For newly entering subjects who do not participate in any other clinical study with BAX 326 the following exclusion criteria apply:
    a) The subject has a history of FIX inhibitors with a titer ≥ 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening.
    b) The subject has a detectable FIX inhibitor at screening, with a titer ≥0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory.
    c) The subject requires emergency surgery.
    d) The subject’s weight is < 35 kg or > 120 kg
    e) The subject has a history of allergic reaction, eg, anaphylaxis, following exposure to FIX concentrate(s).
    f) The subject has a known hypersensitivity to hamster proteins or rFurin.
    g) The subject has evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
    h) The subject has an abnormal renal function (serum creatinine > 1.5 times the upper limit of normal). The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
    i) The subject has active hepatic disease with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 5 times the upper limit of normal.
    j) The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia B.
    k) The subject’s platelet count is < 100,000/mL.
    l) The subject has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject’s safety or compliance.
    m) The subject is currently receiving, or is scheduled to receive during the course of the study, an immunomodulating drug (eg, corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day, or α-interferon) other than anti-retroviral chemotherapy.
    n) The subject has participated in another investigational study within 30 days of enrollment.
    o) The subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees.
    E.5 End points
    E.5.1Primary end point(s)
    • Hemostatic efficacy
    a) Intraoperative hemostatic efficacy
    1. Intraoperative Hemostatic Efficacy Assessment on a scale of “excellent”, “good”, “fair” and “none”
    2. Actual intraoperative blood loss compared to average and maximum blood loss predicted preoperatively
    b) Postoperative hemostatic efficacy
    1. Postoperative Hemostatic Efficacy Assessment at the time of drain removal, if applicable,or at postoperative day 3 (approximately 72 hours postoperatively) in case of major surgery and no drain employed on a scale of “excellent”, “good”, “fair” and “none”
    2. Postoperative Hemostatic Efficacy Assessment at the time of discharge from the hospital on a scale of “excellent”, “good”, “fair” and “none”
    3. Actual postoperative blood loss until drain removal, if applicable, compared to average and maximum blood loss predicted preoperatively
    c) BAX 326 consumption and blood product use
    1. Daily and total weight-adjusted dose of BAX 326 per subject
    2. Number of units and amount (in mL) of blood product transfused
    • Safety
    a) Development of inhibitory and total binding antibodies to FIX
    b) IP-related AEs
    • Determine the occurence of thrombotic events
    • Presurgical Pharmacokinetics (only in subjects undergoing major elective surgery who did not undergo a PK assessment in the Pivotal Study)
    a) Area under the plasma concentration versus time curve from 0 to 72 hours/dose (AUC0-72 h/dose), total AUC/dose, mean residence time (MRT), clearance (CL), Incremental Recovery (IR), elimination phase half-life (T1/2), and volume of distribution at steady state (Vss)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Hemostatic efficacy: interoperative and postoperative at drain removal or postoperative day 3, as well as at discharge.
    Safety: end of the trial
    E.5.2Secondary end point(s)
    n.a.
    E.5.2.1Timepoint(s) of evaluation of this end point
    n.a.
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    hemostatic efficacy
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Argentina
    Brazil
    Chile
    Colombia
    Czech Republic
    Japan
    Poland
    Russian Federation
    Sweden
    Ukraine
    United Kingdom
    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 after approximately 40 surgical procedures in approximately 40 subjects.
    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 months3
    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 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 3
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors 0-17 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 40
    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)
    The patients in the surgery study 251002 that are also included in the continuation study 251001 will be treated with BAX326 until the commercial product is available, therefore the continuous treatment of patients is warranted. Patients who are not also included in continuation study 251001 will return to the treatment they had been using prior to enrollment in the surgery study 251002.
    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 Decision2012-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-15
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