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    Summary
    EudraCT Number:2007-002035-81
    Sponsor's Protocol Code Number:2-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-002035-81
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects with Sepsis and Disseminated Intravascular Coagulation
    A.4.1Sponsor's protocol code number2-001
    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 SponsorArtisan Pharma, Inc.
    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 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 No
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameART-123
    D.3.2Product code ART-123
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNThrombomodulin alfa
    D.3.9.1CAS number 120313-91-9
    D.3.9.2Current sponsor codeART-123
    D.3.9.3Other descriptive nameRecombinant, soluble, human thrombomodulin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.0
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant.
    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 injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sepsis and disseminated intravascular coagulation.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10040047
    E.1.2Term Sepsis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10013442
    E.1.2Term Disseminated intravascular coagulation
    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 safety and activity of ART-123 in reducing mortality in subjects with sepsis and disseminated intravascular coagulation
    E.2.2Secondary objectives of the trial
    To assess the efficacy of ART-123 in resolution of DIC in this population
    To establish the predictive value of a DIC score based on platelet count and INR compared with the ISTH DIC score.
    To evaluate several coagulation parameters in predicting response to ART-123
    To obtain an accurate estimate of the risk of death in subjects with DIC and sepsis.
    To assess the safety of ART-123 in subjects with sepsis and DIC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Candidates for this study must meet ALL of the
    following criteria:
    1. Bacterial infection or suspected bacterial infection and being treated with antimicrobial medication(s).
    2. DIC score of ≥2 using a modified ISTH algorithm
    3. Subject presents with >2 of the following sepsis related SIRS criteria within the 24 hours prior to any particular qualifying DIC score, with one of the two criteria being either temperature or WBC:
    a. Temperature >38ºC or <36ºC (core temperature for low range temperature)
    b. WBC >12,000 or <4,000 cells/μL or >10% Band forms
    c. Heart Rate >90 BPM (This criterion can not be used if the subject is treated with
    β-blockers or heart rate is pacemaker dependent).
    d. Respiratory Rate >20 BPM or PaCO2<32 mmHg or mechanically ventilated subject
    E.4Principal exclusion criteria
    Candidates for the study will be excluded if ANY of the following criteria are present:
    1. Subject or Legally Authorized Representative is unable to provide informed consent
    2. Subject is pregnant or breastfeeding or intends to get pregnant within 28 days of enrolling into the study
    3. Subject is of childbearing potential and does not agree to use a medically acceptable form of contraception for the duration of the trial (28 days or 22 days post the last dose of study drug administration). (see protocol for further details)
    4. Subject is < 18 years of age
    5. Allergy to ART-123 or any components of the drug product
    6. Subject is unwilling to allow transfusion of blood or blood products
    7. Presence of an advance directive to withhold life-sustaining treatment, with the exception of cardiopulmonary resuscitation (CPR)
    8. Previous treatment with ART-123
    9. Body weight ≥ 175kg
    10. DIC not due to sepsis (see protocol for further details)
    11. Intra-thoracic, intra-abdominal, or intra-cranial surgery, within the previous 12 hours to enrollment, or ongoing impairment of hemostasis as a result of one of these procedures
    12. A history of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding within 3 months prior to enrollment (see protocol for further details)
    13. Cerebral Vascular Accident (CVA) within 3 months prior to enrollment
    14. Any history of intracerebral arteriovenous malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system
    15. A history of congenital bleeding diatheses
    16. Gastrointestinal bleeding within 6 weeks prior to enrollment unless a corrective interventional procedure has been performed
    17. Known medical conditions associated with a hypercoagulable state, including:
    a. Resistance to activated protein C or known Factor V Leiden
    b. Hereditary deficiency of protein C, protein S or antithrombin III
    c. Presence of anticardiolipin antibody, antiphosopholipid antibody, lupus anticoagulant, prothrombin gene mutation, or homocysteinemia
    d. Deep-vein thrombois or pulmonary embolism within 3 months prior to enrollment (if evaluation is in progress, this should be completed before consideration for this trial)
    e. History of idiopathic thrombosis
    18. Known or suspected severe liver disease, as defined by a score of 10-15 (class C) using the Child-Pugh Classification (see Appendix G of protocol)
    19. Portosystemic hypertension or known history of bleeding esophageal varices
    20. History of solid organ, allogeneic bone marrow, or stem cell transplantation within 6 months of enrollment (uncomplicated kidney and autologous stem cell/bone marrow transplant subjects may be enrolled at any time after they have recovered from their transplant procedure)
    21. Acute pancreatitis where infection has not been documented by a positive blood or abdominal fluid culture. Also, in the opinion of the treating physician the subject is an increased risk for developing hemorrhagic pancreatitis over the duration of the study.
    22. Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis.
    23. Use or intended use of Xigris® (drotrecogin alfa [activated]) within the 24 hours prior of enrollment
    24.Use or intended use of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics within the 24 hours prior to study dosing with the exception of:
    a. Heparin locks/flushes
    b. DVT Prophylaxis with either unfractionated heparin at total daily doses no higher than 10000 U SQ or LMWH at a total daily dose no higher than 15000 U SQ (no switching or alternating between unfractionated heparin and LMWH is allowed during treatment and up to Study Day 14)
    c. Up to 325 mg of aspirin daily for cardiac prophylaxis
    25. Platelet count <20,000 OR platelet count <30,000 after platelet transfusion
    26. Life expectancy <90 days due, but not limited to, the following conditions:
    a. Poorly controlled neoplasms
    b. New York Heart Association class IV subjects or pulmonary vascular disease resulting in severe exercise restriction (i.e., unable to climb stairs or perform household duties), or chronic restrictive or obstructive pulmonary disease that also results in severe exercise restriction, or documented chronic hypoxia, hypercapnia, secondary polycythemia, severe pulmonary hypertension (mean arterial pulmonary pressure >40 mm Hg) or respirator dependency
    c. Prior cardiac arrest requiring CPR without fully demonstrated neurological recovery, or subject with imminent death
    d. End-stage neurological disorders (e.g., amyotrophic lateral sclerosis – Lou Gehrig’s disease)
    27. Use of any chemotherapy agent
    28. Participation in another research study involving an investigational agent within 30 days prior to enrollment
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis will test the difference in the 28-day all-cause mortality rates between treatment groups in the ITT population. The rates will be estimated from the product-limit (Kaplan-Meier) with an asymptotic variance determined from Greenwood’s formula. Missing data will be censored
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 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 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 last patient's last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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
    Many subjects who will be eligible for this protocol will not be able to give fully informed consent themselves due to various reasons including sedation, or being in an unconscious state.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 490
    F.4.2.2In the whole clinical trial 800
    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)
    Normal treatment for the patient's condition will continue after the study.
    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 Decision2007-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-05-22
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