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    Summary
    EudraCT Number:2011-003474-86
    Sponsor's Protocol Code Number:NCT0023595
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-11-02
    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 ConcernedFinland - Fimea
    A.2EudraCT number2011-003474-86
    A.3Full title of the trial
    Albumin in Acute Stroke (ALIAS) Trial-Part 2: A Phase III Randomized Multicenter Clinical Trial of High-Dose Human Albumin Therapy for Neuroprotection in Acute Ischemic Stroke

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Albumin in Acute Stroke (ALIAS) Trial-Part 2
    A.3.2Name or abbreviated title of the trial where available
    ALIAS
    A.4.1Sponsor's protocol code numberNCT0023595
    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 SponsorMyron D. Ginsberg
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe National Institute of Neurological Disorders and Stroke (NINDS)
    B.4.2CountryUnited States
    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.2.1.1.1Trade name Buminate 25%
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameBuminate 25%
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 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
    Acute Ischemic Stroke
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    To ascertain whether high-dose human albumin (ALB) therapy confers neuroprotection in acute ischemic stroke over and above best standard of care. (Specifically, to determine whether ALB therapy increases the proportion of acute ischemic stroke patients with favorable outcome compared to placebo therapy at 3 months from randomization, as measured by the NIHSS and mRS.)
    E.2.2Secondary objectives of the trial
    To evaluate: - overall clinical outcome (as assessed by the global statistical test of NIHSS, mRS, and BI scores) at 3 months post-randomization, - overall clinical outcome as assessed by the full scale of the modified Rankin scale, - neurological outcome as assessed by NIHSS score at 3 months post-randomization, - functional outcome as assessed by mRS and BI at 3 months post-randomization, - quality-of-life as assessed by EuroQol at 3 months and 1 year post-randomization, and by SSQOL instruments at 3 months post-randomization, - robustness of ALB therapy as measured by a favorable outcome of mRS of 0 or 1at one year post-randomization, - incidence of recurrent ischemic stroke within 1 month, 3 months and 1 year post-randomization, as assessed by QVSFS, - mortality within 3 months and 1 year post-randomization, - incidence of symptomatic ICH within 24 (± 6) hours of randomization, - cognition measured at 3 months by Trailmaking A and B.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Acute ischemic stroke
    - Age 18 years through 83 years (have not had their 84th birthday).
    - NIHSS score of 6 or greater as assessed immediately prior to intravenous thrombolysis treatment if the patient is eligible for intravenous thrombolysis or immediately prior to randomization for patients not eligible for intravenous thrombolysis.
    - Initiation of ALB/placebo within 5 hours of stroke onset, and within 90 minutes of the start of thrombolysis with intravenous (IV) tPA if that therapy is used. Signed and dated informed consent has been obtained.
    E.4Principal exclusion criteria
    - Episode/exacerbation of congestive heart failure (CHF) from any cause in the last 6 months.
    - Known valvular heart disease with CHF in the last 6 months.
    - Known (or in the Investigator’s clinical judgment) existence of severe aortic stenosis or mitral stenosis.
    - Cardiac surgery involving thoracotomy in the last 6 months.
    - Acute myocardial infarction in the last 6 months.
    - Signs or symptoms of acute myocardial infarction, including EKG findings, on admission.
    - Elevated serum troponin level on admission (> 0.1 mcg/L)
    - Suspicion of aortic dissection on admission.
    - Acute arrhythmia with hemodynamic instability on admission
    - Findings on physical examination of any of the following: (1) jugular venous distention; (2) 3rd heart sound; (3) resting tachycardia attributable to congestive heart failure; (4) lower extremity pitting edema attributable to congestive heart failure; abnormal hepatojugular reflux; (5) bilateral rales; and/or (6) if a chest x-ray is performed, definite evidence of pulmonary edema, bilateral pleural effusion, or pulmonary vascular redistribution
    - Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.
    - Historical modified Rankin Scale (mRS) >2. Patients who live in a nursing home or who are not fully independent for activities of daily living, immediately prior to the stroke are not eligible for the trial.
    - In-patient stroke. Patients with stroke occurring as a complication of hospitalization for another condition, or as a complication of a procedure.
    - Profound dehydration.
    - Fever, defined as core body temperature > 38.0oC
    - Serum creatinine > 2.0 mg/dL or 180 mol/L
    - Severe chronic anemia (hemoglobin < 7.5 g/dL or 75g/L).
    - Evidence of intracranial hemorrhage (intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan.
    - History of or known allergy to albumin.
    - History of or known allergy to natural rubber latex.
    - Pregnancy, breastfeeding or positive pregnancy test.
    - Concurrent participation in any other therapeutic clinical trial.
    - Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol, impair the assessment of outcome, or in which ALB therapy would be contraindicated or might cause harm to the subject.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the favorable outcome, defined as either NIH Stroke Scale (NIHSS) score of 0 or 1, or a modified Rankin Score (mRS) of 0 or 1, or both, measured at 3 months from randomization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months from randomization
    E.5.2Secondary end point(s)
    Secondatory end points are measured, as specified, out to 12 months from randomization.
    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 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 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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    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
    Canada
    Finland
    Israel
    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
    Patients are followed up to 12 month after randomization
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 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
    symptoms of acute stroke
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 1100
    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 Decision2011-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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