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    Summary
    EudraCT Number:2017-002514-32
    Sponsor's Protocol Code Number:NPT-CL-01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2018-07-05
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-002514-32
    A.3Full title of the trial
    XePOHCAS: Prospective, randomized, multicenter, interventional trial in adult subjects with out-of-hospital cardiac arrest (OHCA) comparing treatment with standard-of-care post-cardiac arrest intensive care (which is targeted temperature management [TTM]) to standard-of-care post-cardiac arrest intensive care (including TTM) plus xenon by inhalation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    XePOHCAS is a prospective, randomized, multicenter, interventional trial in adult subjects with OHCA during which the standard-of-care for post–cardiac arrest intensive care (including TTM) is compared to the same treatment with the addition of 50% xenon by inhalation.
    A.3.2Name or abbreviated title of the trial where available
    XePOHCAS
    A.4.1Sponsor's protocol code numberNPT-CL-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03176186
    A.5.4Other Identifiers
    Name:INDNumber:125630
    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 SponsorNeuroproteXeon, 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 supportNeuroproteXeon, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeuroproteXeon, Inc.
    B.5.2Functional name of contact pointMervyn Maze
    B.5.3 Address:
    B.5.3.1Street Address50 Cobham Drive
    B.5.3.2Town/ cityOrchard Park, New York
    B.5.3.3Post code14127
    B.5.3.4CountryUnited States
    B.5.4Telephone number+17163327200
    B.5.5Fax number+17162428940
    B.5.6E-mailmervyn.maze.cal@neuroprotexeon.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 numberEU/3/16/1678
    D.3 Description of the IMP
    D.3.1Product nameXENEX™ (Xenon gas for inhalation)
    D.3.4Pharmaceutical form Medicinal gas, compressed
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNXenon
    D.3.9.2Current sponsor codeXENEX™
    D.3.9.3Other descriptive nameXenon gas by inhalation
    D.3.9.4EV Substance CodeSUB32179
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) 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 Yes
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post-cardiac arrest syndrome
    E.1.1.1Medical condition in easily understood language
    A syndrome including all clinical and biological manifestations related to
    the phenomenon of global ischemia-reperfusion triggered by cardiac
    arrest and return of spontaneous circulation.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10078202
    E.1.2Term Post cardiac arrest syndrome
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate, on Day 30 and Day 90 post OHCA, whether there is a difference in functional outcome in comatose subjects who achieved restoration of spontaneous circulation (ROSC) within 30 minutes after OHCA and were treated during TTM with xenon (50% ±2%) + oxygen (50% ±3%) vs. those receiving similar oxygen (50% ±3%) treatment during TTM, but without supplementary xenon during TTM.
    E.2.2Secondary objectives of the trial
    - To evaluate whether there is a difference in percent of subjects surviving to Day 30 and Day 90 post-OHCA following treatment with xenon (50%±2%) + oxygen (50%±3%) during TTM, compared to treatment with oxygen(50%±3%) treatment (without xenon) during TTM.
    - To compare time to achieve target body temperature in OHCA subjects treated with xenon (50%±2%) + oxygen (50%±3%) during TTM, compared to similar oxygen (50%±3%) treatment (without xenon) during TTM.
    - To test for, estimate, and adjust for multivariable effects of selected covariates on Day 30 and Day 90 functional outcome and proportionate survival in subjects treated with xenon (50%±2%) + oxygen (50%±3%) during TTM, compared to similar oxygen (50%±3%) treatment (without xenon) during TTM.
    - To conduct sensitivity analyses to investigate the effects of subject dropout on the magnitude of estimates of treatment effects on the primary endpoint.
    - To evaluate the safety and tolerability of xenon therapy in the treatment of OHCA.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Regional Addendum for Europe No. 2 (29 June 2018):
    A 1-year follow up assessment was included in order to support the request of the EMA to provide long-term efficacy and safety data at European sites.
    The study population will include a subset of subjects (300) enrolled in the XePOHCAS study who completed the Day 90 functional outcome assessment.
    The primary objective is to evaluate, on Day 365 after out-of-hospital cardiac arrest (OHCA), whether there is a difference in functional outcome in comatose subjects who achieved restoration of spontaneous circulation (ROSC) within 30 minutes after OHCA and were treated during targeted temperature management (TTM) with xenon 50% + oxygen versus those receiving similar oxygen treatment during TTM, but without supplementary xenon.
    The secondary objectives for this regional addendum for Europe are as follows:
    • To evaluate, at Day 365 post-OHCA, whether the Day 90 functional status of European subjects receiving xenon 50% + oxygen has been maintained.
    • To evaluate whether there is a difference in percent of subjects surviving to Day 365 post-OHCA following treatment with xenon 50% + oxygen during TTM, compared to treatment with oxygen (without xenon) during TTM.
    • To conduct sensitivity analyses to investigate the effects of subject dropout on the magnitude of estimates of treatment effects on the primary endpoint of this regional addendum.
    The exploratory objectives for this regional addendum for Europe are as follows:
    • To test for distributional differences in ordinal mRS scores in subjects receiving xenon 50% + oxygen during TTM, compared to similar oxygen treatment (without xenon) during TTM at Day 365 post-OHCA.
    • To evaluate differences in the quality of life on Day 365, assessed by the EQ-5D-3L, in subjects receiving xenon 50% + oxygen during TTM, compared to similar oxygen treatment (without xenon) during TTM.
    • To evaluate difference in resource utilization in subjects receiving xenon 50% + oxygen during TTM, compared to similar oxygen treatment (without xenon) during TTM.

    Regional Addendum for Europe No. 1 (29 June 2018):
    Performance and safety data of the XDSTM will be obtained to demonstrate compliance with the relevant General Requirements set out in EU legislation.
    E.3Principal inclusion criteria
    1. Age at least 18 but less than or equal to 80 years.
    2. Presumed cardiac cause of arrest.
    3. ROSC within 30 minutes of cardiac arrest and sustained for >20 minutes.
    4. No response to verbal commands prior to randomization (Glasgow Coma Scale score of <8).
    5. Decision by the attending physician that the subject is eligible for TTM.
    E.4Principal exclusion criteria
    1. A written do not attempt resuscitation is reported to providers before randomization.
    2. There is a traumatic etiology of arrest, defined as concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination.
    3. The subject is suspected or known to be having a stroke, intracranial hemorrhage or raised intracranial pressure.
    4. The cardiac arrest was unwitnessed.
    5. The subject has a no-flow (cardiac arrest to initiation of chest compressions) time of greater than 10 minutes.
    6. The interval from the cardiac arrest to initiation of TTM is greater than 5 hours.
    7. The interval from the cardiac arrest to initiation of xenon treatment is greater than 5 hours.
    8. The subject is experiencing hypothermia (less than 30°C core temperature).
    09. The subject experienced unconsciousness before cardiac arrest (cerebral trauma, spontaneous cerebral hemorrhage, intoxication etc.).
    10. The subject suffers from coagulopathy, not including intentional therapeutically-induced anticoagulation.
    11. The subject has a systolic arterial pressure less than 80 mmHg or a mean arterial pressure less than 60 mmHg lasting for more than 30 minutes after ROSC or requires a non-pharmacologic cardiac assist device to maintain hemodynamic stability.
    12. The subject is known to be pregnant or breastfeeding.
    13. The subject has received an investigational drug, device, or biologic product within 30 days.
    14. The subject has experienced hypoxemia (saturation of arterial oxygen [SaO2] or oxygen saturation determined by periphery oximetry [SpO2] less than 85%) for more than 30 minutes after ROSC.
    15. The subject is unable to maintain a SaO2 or SpO2 of ≥90% while on an FiO2 of 0.5.
    16. The subject requires extra-corporal membrane oxygenation for gas exchange and/or perfusion.
    17. The subject is known to be in the terminal phase of a chronic illness or has any other clinically significant laboratory abnormality, medical condition (such as decompensated liver disease or severe chronic obstructive pulmonary disease), or social circumstance that, in the investigator’s opinion, makes it inappropriate for the subject to participate in this clinical trial.
    18. It is logistically impossible to provide intervention.
    19. The subject is known to have a moderate or severe disability precluding their independent performance of complex tasks (e.g., shopping, cleaning, cooking) before the OHCA.
    20. The subject has a known history of malignant hyperthermia.
    E.5 End points
    E.5.1Primary end point(s)
    For both the interim and the final analyses, the primary efficacy endpoint will be the binomial proportion of subjects with good functional outcome on Day 30 and Day 90 post-OHCA. Good functional outcome will be defined as an mRS ≤2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 30 days and 90 days post-arrest.
    E.5.2Secondary end point(s)
    - The binomial proportion of subjects surviving to Day 30 and Day 90 following treatment with xenon (50% ±2%) + oxygen (50% ±3%) during TTM or a similar oxygen (50% ±3%) treatment (without xenon) during TTM.

    - Body temperature, during the Intervention Phase, in OHCA subjects treated with xenon (50% ±2%) + oxygen (50% ±3%) during TTM or with a similar oxygen (50% ±3%) treatment (without xenon) during TTM.

    - Covariates, including site, treatment arm, mode and rate of TTM, initial rhythm, time to ROSC, age, gender, and presence of shock, that may affect Day 30 and Day 90 functional outcome and proportionate survival in subjects treated with xenon (50% ±2%) + oxygen (50% ±3%) during TTM or with a similar oxygen (50% ±3%) treatment (without xenon) during TTM.

    - The number and timing of subjects who do not complete the study through the evaluation phase, unless the reason for discontinuation is death.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 30 days and 90 days post-arrest.
    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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Treating medical personnel: unblinded / Long-term evaluation rater: blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard-of-care for post–cardiac arrest intensive care (including TTM)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Austria
    Canada
    Denmark
    France
    Germany
    Poland
    Spain
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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: 930
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-07-05. Yes
    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
    Unconscious subjects who need urgent care.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state175
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1436
    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)
    The best patients' treatment or care after study participation will be discussed with the respective investigator.
    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 Decision2018-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-12
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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