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    Summary
    EudraCT Number:2009-009657-19
    Sponsor's Protocol Code Number:S201
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-06-10
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-009657-19
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multi-center study of IK-1001 to evaluate safety, population pharmacokinetics and proof-of-concept efficacy for reduction of ischemia-reperfusion mediated cardiac injury in subjects undergoing coronary artery bypass graft (CABG) surgery.
    A.4.1Sponsor's protocol code numberS201
    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 SponsorIkaria, 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.2.5The 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 nameSodium Sulfide for Injection
    D.3.2Product code IK-1001
    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 1313-84-4
    D.3.9.2Current sponsor codeIK-1001
    D.3.9.3Other descriptive nameSodium Sulfide nonahydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.5 to mg/ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    It will be conducted in subjects undergoing coronary artery bypass graft (CABG) surgery
    MedDRA Classification
    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 objectives of this study are to evaluate safety, pharmacokinetics (PK) and proof-of-concept (POC) therapeutic efficacy of IK-1001, measured as a reduction (25% compared to placebo) in serum levels of CK-MB and Cradiac Troponin T at 24 hours, and area under concentration-time curve (AUC) at 72 hours post-end of infusion (EOI) when administered intravenously during coronary artery bypass surgery in subjects with coronary artery atherosclerosis who are at an increased risk for ischemia-reperfusion (I/R) mediated cardiac tissued damage.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess the impact of IK-1001 as compared to placebo in subjects undergoing coronary artery bypass graft (CABG) on:
    1 Mortality
    2. Incidence of nonfatal MI
    3. The composite of cardiovascular death, nonfatal MI, nonfatal stroke, and renal
    insufficiency
    4. Incidence of nonfatal stroke
    5. Renal insufficiency
    6. Incidence of unstable angina
    7. Incidence of new atrial fibrillation
    8. Change in LV function
    9. Need for vasopressor and inotropes during study drug
    infusion
    10.Need for intra-aortic balloon pump (IABP) post surgery
    11. Re-admission and subsequent re-intervention for coronary artery disease, (percutaneous coronary intervention
    12.Length of intubation
    13.Length of stay in cardiac surgery intensive care unit (ICU) or equivalent
    14.Length of hospital stay
    15.The markers of oxidative stress and inflammation









    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be 18 to 85 years of age
    2. Subject is scheduled to undergo CABG surgery with cardiopulmonary
    bypass
    3. Subjects at an increased risk for I/R mediated tissue damage: defined as
    subjects with ≥ 30% but ≤ 50% ejection fraction (as measured by:
    echocardiography within 14 days of study enrollment) or who fulfill at
    least two of the following criteria:
    • Current or recent smoker (within last 6 months prior to screening)
    • Female
    •. Diabetes mellitus (a history of diabetes, regardless of duration of disease
    or need for antidiabetic agents)
    • History of non-disabling stroke, transient ischemic attack (TIA), or carotid
    endarterectomy
    • Re-CABG surgery (history of [H/O] previous CABG surgery by any
    approach, on or off pump)
    • Peripheral artery surgery or angioplasty
    • Recent MI (≥ 48 hours and ≤ 6 weeks before enrollment, non-STEMI and STEMI
    infarcts as documented in the medical records of the subject)
    • History of congestive heart failure (CHF) (NYHAssociation CHF Class III or IV)
    • Renal dysfunction (creatinine clearance ≥ 30mL/min, but < 60mL/min) calculated
    using Cockroft and Gault formula:
    • Asymptomatic stenosis (≥ 50%) in ≥ 1 carotid artery
    • Age > 65 years
    E.4Principal exclusion criteria
    1. Known sulfite allergy or sulphur drug allergy.
    2. Myocardial infarction occurring < 48 hours prior to surgery.
    3. Current cardiogenic shock, acute left ventricular rupture, ventricular septal
    rupture, or papillary muscle rupture
    4. Subject has an ejection fraction ≤ 30% (as measured by echocardiography within
    14 days of study enrollment)
    5. History of prior disabling stroke
    6. Severe renal dysfunction defined as a creatinine clearance of < 30mL/min
    7. Clinically relevant liver disease (serum transaminases ≥ ULN x 3)
    8. Uncontrolled diabetes mellitus (HbA1c > 9.0%)
    9. Planned concomitant valve or other surgery
    10. All females of child bearing potential as determined by medical history and
    Principal Investigator evaluation
    11. Ongoing alcohol -or drug abuse
    12. Any underlying medical or psychiatric condition that, in the opinion of the
    investigator, makes the subject an unsuitable candidate for the study
    13. Subject has participated in another investigational drug or device study within
    30 days prior to enrollment to the study.
    E.5 End points
    E.5.1Primary end point(s)
    There are four potential primary endpoints:

    1. A 25% reduction in the release of CK-MB in IK-1001 treated subjects
    compared with placebo treated subjects, measured at 24 hours post EOI.

    2. A 25% reduction in the release of CK-MB in IK-1001 treated subjects compared
    with placebo treated subjects, measured as AUC during 72 hours post EOI.

    3. A 25% reduction in the release of Cardiac Troponin T in IK-1001 treated
    subjects compared with placebo treated subjects, measured at 24 hours post
    EOI.
    4. A 25% reduction in the release of Cardiac Troponin T in IK-1001 treated subjects
    compared with placebo treated subjects, measured as AUC during 72 hours post
    EOI.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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) 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 concerned8
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA8
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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 No
    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 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 state252
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 252
    F.4.2.2In the whole clinical trial 668
    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)
    There are no further treatments other than standard of 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 Decision2009-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-12-17
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