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    Summary
    EudraCT Number:2010-019760-36
    Sponsor's Protocol Code Number:T05018-2004
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-16
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2010-019760-36
    A.3Full title of the trial
    A Phase 2, Randomized, Open-label (with Blinded Plasminogen Activator and Placebo Control Groups) Study to Evaluate the Effects of Different Intra-thrombus Infusion Regimens of Plasmin (Human) Compared to Plasminogen Activator and Placebo In Patients With Acute Lower Extremity Native Artery or Bypass Graft Occlusion
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the drug, Plasmin (Human), in patients with clots in large arteries of the lower leg
    A.4.1Sponsor's protocol code numberT05018-2004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01222117
    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 SponsorGrifols Therapeutics, Incorporated
    B.1.3.4CountryUnited States
    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 supportGrifols Therapeutics, Inc. (4101 Research Commons, 79
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrifols Therapeutics, Inc.
    B.5.2Functional name of contact pointRenu Jain
    B.5.3 Address:
    B.5.3.1Street Address4101 Research Commons, 79 T.W. Alexander Drive
    B.5.3.2Town/ cityResearch Triangle Park, North Carolina
    B.5.3.3Post code27709
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 919 316 6480
    B.5.5Fax number+1 919 316 6352
    B.5.6E-mailRenu.Jain@grifols.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/117/10
    D.3 Description of the IMP
    D.3.1Product namePlasmin (Human)
    D.3.2Product code TAL 05-00018
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 9001-90-5
    D.3.9.2Current sponsor codeTAL-05-00018
    D.3.9.3Other descriptive nameActive plasmin protein
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0,5-2,1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntraarterial use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute peripheral arterial occlusion
    E.1.1.1Medical condition in easily understood language
    Clots in the large arteries of the lower leg
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10057525
    E.1.2Term Peripheral artery occlusion
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the safety and tolerability of different methods of
    administering Plasmin through analysis of major and minor bleeding
    events, deaths, AEs, SAEs, and abnormal laboratory values.
    E.2.2Secondary objectives of the trial
    1. Avoidance of major surgical revascularization, mechanical device
    thrombectomy, major amputation (ankle and above), and CDT with a PA
    in the affected extremity from end of treatment to Day 30.
    2. Ankle brachial index (ABI) improvement of ≥0.15 at the end of
    treatment and/or at post intervention time point (if performed).
    3. Assessment of blood flow in treated native artery or graft by
    ultrasound at the end of treatment or post-intervention and Day 30.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Unilateral limb ischemia: symptomatic, SVS acute ischemic Categories I and IIa
    2. Onset of symptoms ≤ 14 days
    3. Thrombosed (non-embolic) infrainguinal graft (synthetic, autologous, or single outflow composite) or infrainguinal native artery. For native arteries, occlusions of ≥ 10 cm in length are eligible (Note: Only the sites that have the capability of correcting the underlying lesion in the native artery [eg, appropriate supply of the
    required stents or long angioplasty balloons] will enroll subjects with occluded native artery.)
    4. Diagnosis of occlusive thrombus in the graft or artery by arteriography after informed consent is obtained
    5. Ability to access the thrombus with the infusion catheter and successfully embed the infusion segment of the
    infusion catheter.
    6. Subject must be able to give written informed consent prior to study entry
    7. Age ≥18 years
    8. Women of childbearing potential must use adequate contraception for the duration of the study and must have a
    negative pregnancy test prior to study entry
    E.4Principal exclusion criteria
    1. Any medical or social condition that may interfere with the subject successfully completing the study
    2. Women who are pregnant or lactating, or first 10 days post-partum Past Medical History
    3. Definitive flow on duplex ultrasound through the occluded segment at baseline
    4. Cardiopulmonary resuscitation in the last year
    5. Previous systemic or anaphylactoid allergy to contrast agent,
    streptokinase, or blood products (subjects allergic to shellfish or iodine are permitted to enter the study).
    6. Ineligible for thrombolytic treatment for any reason
    Specific exclusions include: a. History of hemorrhagic stroke, b.
    Thrombotic or embolic stroke or cerebrovascular events (including
    transient ischemic attack [TIA]) within the past year, c. Intracranial or spinal neuro-surgery or severe intracranial trauma in the past 3 months,d. Major surgery, organ biopsy, or major trauma within the past 10 days, e. Lumbar puncture or non-compressible arterial puncture in the past 10
    days, f. Intra-ocular surgery within the past 10 days, g. Active
    gastrointestinal or organ bleeding. Minor bleeding such as normal
    menses, cystitis, or minor hemorrhoidal bleeding are not exclusions, h. Uncontrolled arterial hypertension, defined as a systolic blood pressure
    >180 millimeters of mercury (mmHg) or diastolic blood pressure >110 mmHg. The subject will be eligible if the hypertension is controlled at the time of study enrollment., i. Known intracranial neoplasm, aneurysm, or arterio-venous malformation, j. Current bleeding diathesis, k. Platelet count <75 x 109/L, l. Subtherapeutic levels of unfractionated heparin
    anticoagulation as indicated by partial thromboplastin time (aPTT) <50 seconds or activated clotting time (ACT) <300 seconds (subtherapeutic anticoagulation level may be corrected by administration of additional heparin). Testing (aPTT or ACT) may be repeated prior to randomization.
    7. Active graft infection
    8. Occlusion occurred within one month of synthetic graft placement.
    9. Occlusion occurred within 6 months of autologous graft placement
    10. A sequential composite graft with dual outflows to correct multiple occlusions
    11. Deemed by the Investigator to be medically unable to tolerate open vascular procedure
    12. Known prothrombotic state, e.g., anti-cardiolipin antibody, human immunodeficiency virus (HIV)-associated peripheral vascular disease
    13. Known contraindication to heparin (e.g., history of heparin-induced thrombocytopenia)
    14. Hemoglobin <10.0 g/dL (low hemoglobin at screening in the absence of active bleeding may be corrected by transfusion). Hemoglobin testing can be repeated.
    15. Impaired renal function or renal disease that constitutes a
    contraindication to contrast arteriography, including a screen/baseline creatinine of >2.0 mg/dL. Creatinine may be repeated following hydration for prerenal azotemia.
    16. Active cancer except non-malignant tumors or basal cell carcinoma
    17. Previous treatment with Plasmin
    18. Treatment with full dose plasminogen activator (e.g., streptokinase
    (e.g., Streptase®, Kabikinase®), anistreplase (Eminase®), alteplase
    (e.g., Activase®), reteplase (e.g., Retavase®), tenecteplase (TNKase™),
    XML File Identifier: 5lUQYyZboSugeIeEkSwfhzFzVcs=
    Page 15/27
    urokinase (UK, [Abbokinase®]) within the last 48 hours
    19. Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor
    within 5 days prior to study entry or at any time during the study, e.g., abciximab (ReoPro®), eptifibatide (Integrilin®) or tirofiban
    (Aggrastat®)
    20. Treatment with oral anticoagulants (e.g., warfarin, acenocumarol), and with an international normalized ratio (INR) of >1.7 (elevated INR at screening may be corrected prior to study enrollment). INR testing can be repeated.
    21. Participation in another clinical study within 30 days prior to entry (imaging studies without investigative treatment are permitted), or concomitant
    participation in another study.
    22. Mentally challenged adult subjects who cannot give independent
    written informed consent.
    23. Weight <62.5 kg (only for groups K, L and M)
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects with >50% thrombolysis at the end of treatment compared to baseline by arteriography
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 hours and 15 hours
    E.5.2Secondary end point(s)
    The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Open treatment groups, blinded comparator groups
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 EEA65
    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
    Belgium
    Brazil
    Bulgaria
    Czech Republic
    Germany
    Hungary
    India
    Peru
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    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
    last visit last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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
    Patients must be willing to provide written informed consent or have a legal representative able to provide written informed consent on behalf of the patient in accordance with local law and institutional policy.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 160
    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)
    N/a
    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 Decision2010-11-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-03
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