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    Summary
    EudraCT Number:2005-003638-17
    Sponsor's Protocol Code Number:HEMOPURE II and/or COR-002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-07
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-003638-17
    A.3Full title of the trial
    This is a phase II, open-label study in the catheterization laboratory setting to challenge the concept that HBOC-201 ® administration might improve myocardial ‘oxygenation’ and myocardial function at the moment of (brief) coronary occlusion.
    A.3.2Name or abbreviated title of the trial where available
    HEMOPURE II and/or COR-002
    A.4.1Sponsor's protocol code numberHEMOPURE II and/or COR-002
    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 SponsorBiopure Corporation
    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 Information not present in EudraCT
    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 nameHemopure
    D.3.2Product code HBOC-201
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codehaemoglobin glutamer-250 (bovine)
    D.3.9.3Other descriptive namepolymerised bovine haemoglobin
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number120 to 140
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 typePolymerised bovine haemoglobin
    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 placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntracoronary use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of several ischemic conditions, such as acute coronary syndromes (ACS)
    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
    Main objective :
    To investigate whether intracoronary delivery (IC) of HBOC-201® to the myocardium at risk during coronary flow interruption mitigates ischemia as measured by LV pressure-volume loop analysis and continuous Holter ECG recording.
    E.2.2Secondary objectives of the trial
    Secondary objectives :
    1. to study clinical signs and symptoms of myocardial ischemia during the investigational procedure;
    2. to collect safety information regarding the IC delivery of HBOC-201®;
    3. to collect (additional) information concerning the occurrence and (potential) management of systemic vasoconstrictive effects (increase in systemic blood pressure) during study drug infusion;
    4. to investigate the local vasoconstrictive effect on coronary artery diameters as assessed with off-line quantitative coronary analysis (QCA) based on angiograms performed before and immediately after the placebo and HBOC-201® infusions.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients to be included in the study must meet the following inclusion criteria:
    1. Written informed consent provided before initiation of any study-related procedure, and before any pre-procedural sedation, and agreement to comply with all protocol-specific procedures.
    2. Stable angina pectoris (CCS Class 1, 2, 3, 4) or unstable angina (Braunwald class 1-3, B) or documented silent ischemia.
    3. Baseline ECG with stable sinus rhythm and no signs of ischemia and with no Q waves, bundle branch block or IV conduction disturbances.
    4. Normal left ventricular (LV) wall motion on left ventricular angiogram or on
    echocardiogram with preserved (ejection fraction: 55%) systolic global LV function.
    5. Non-occlusive stenosis, located in the proximal segments of the left anterior descending artery (LAD) (segments 6 and/or 7) and/or circumflex artery (CFX) (segments 11 and/or 12) or right coronary artery (RCA) (segments 1, 2 and/or 3) for which there is clinical indication to percutanous treatment with coronary stenting.
    6. Successful PCI with stenting on the target vessel.
    7. Older than 18 years and younger than 80 years of age
    E.4Principal exclusion criteria
    Patients will be excluded from the study if any of the following exclusion criteria apply, prior to study enrollment:
    1. Active ischemia at the initiation of the study procedure (i.e. post-PCI).
    2. Non-ST segment elevation myocardial infarction (patients with any troponin elevation within the last 5 days).
    3. History or ECG evidence of prior MI in the territory supplied by the vessel undergoing PCI, IV conduction defects/baseline ST-segment abnormalities on the surface ECG.
    4. Evidence of left ventricular (LV) hypertrophy on the echocardiogram.
    5. Angiographically visible collateral vessels to the target vessel.
    6. Hypertension not adequately controlled by anti-hypertensive therapy at the time of study entry (> 140/100 mmHG).
    7. Uncompensated congestive heart failure or signs of pulmonary edema.
    8. Significant hemodynamic compromise and/or cardiogenic shock requiring inotropic or pressor support.
    9. Contraindications to standard drugs for coronary intervention and coronary heart disease: aspirin, heparin, low molecular weight heparin, clopidogrel, contrast dye.
    10. Confirmed pregnancy.
    11. Systemic mastocytosis.
    12. Hypoxemia (need for mechanical ventilation).
    13. Known history of COPD with FEV 1s <1.0 liter.
    14. Renal impairment: Creatinine > 1. 6 g/dl.
    15. Participation in another trial with an investigational drug or device (of other
    investigations) including the follow-up period, within the last 30 days before enrollment.

    Additional exclusion criteria at the end of PCI (i.e. before randomization)
    Patients will be excluded from further study participation and replaced if one or more of the following conditions occurs:
    1. Coronary TIMI flow in the treated artery is less than 3.
    2. Serious arrhythmia during/following the PCI was noted (ventricular fibrillation or
    ventricular tachycardia).
    3. Coronary spasm following PCI.
    4. Any changes in the patient’s “risk” status between informed consent and randomization, in particular with regard to systemic hemodynamic alterations (a systolic blood pressure >180 mmHG, pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic
    pressure (LVEDP) >20 mmHG).
    E.5 End points
    E.5.1Primary end point(s)
    To study the change in left ventricular relaxation indices (relaxation time constant [Tau, ms] and pressure-half time [PHT, ms] as measured by LV pressure-volume loop analysis) and the change in the sum of ST segment deviations (as assessed by continuous 12-lead Holter ECG monitoring) compared to baseline.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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 Decision2005-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-30
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