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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-000939-31
    Sponsor's Protocol Code Number:JDS_2021_5
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-03-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-000939-31
    A.3Full title of the trial
    Efficacy of dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy angiography in patients managed for ischemic stroke by thrombolysis and eligible for thrombectomy: a monocentric phase II trial.
    Évaluation de l’efficacité de la dornase alfa (Pulmozyme®) en administration IV sur la recanalisation artérielle en angiographie post-thrombectomie chez les patients pris en charge pour un AVC ischémique par thrombolyse et éligibles à la thrombectomie : un essai monocentrique de phase II.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy angiography in patients managed for ischemic stroke by thrombolysis and eligible for thrombectomy: a monocentric phase II trial.
    Évaluation de l’efficacité de la dornase alfa (Pulmozyme®) en administration IV sur la recanalisation artérielle en angiographie post-thrombectomie chez les patients pris en charge pour un AVC ischémique par thrombolyse et éligibles à la thrombectomie : un essai monocentrique de phase II.
    A.4.1Sponsor's protocol code numberJDS_2021_5
    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 SponsorHôpital Fondation A. de Rothschild / Service de recherche clinique
    B.1.3.4CountryFrance
    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 supportHôpital Fondation A. de Rothschild
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital Fondation A. de Rothschild / Service de recherche clinique
    B.5.2Functional name of contact pointAdministrative Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Fondation A de Rothschild, 29 rue Manin
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75019
    B.5.3.4CountryFrance
    B.5.6E-mailpvachey@for.paris
    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 Yes
    D.2.1.1.1Trade name DORNASE ALFA
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Inhalation solution
    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 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
    cerebral thrombectomy
    thrombectomie cérébrale
    E.1.1.1Medical condition in easily understood language
    cerebral thrombectomy
    thrombectomie cérébrale
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    Evaluate the efficacy of intravenous administration of dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy angiography in patients managed for ischemic stroke by thrombolysis and eligible for thrombectomy
    Évaluer chez les patients pris en charge pour un AVC ischémique par thrombolyse et éligibles à la thrombectomie, l’efficacité de l’administration intraveineuse de dornase alfa (Pulmozyme®) sur la recanalisation artérielle en angiographie post-thrombectomie
    E.2.2Secondary objectives of the trial
    To evaluate in patients managed for ischemic stroke by thrombolysis and eligible for thrombectomy, the efficacy of IV administration of dornase alfa on :
    1. The rate of early recanalisation in pre-thrombectomy angiography
    2. Improvement in the recanalisation rate between the last pass of TM and one hour after dornase alfa administration (for TM procedures <1h)
    3. The duration of the thrombectomy procedure
    4. The number of thrombectomy passages
    5. The occurrence of an embolus in a new territory (ENT) during the TM procedure
    6. The volume of the final cerebral infarction
    7. Rate of haemorrhagic transformation at 24 hours
    8. Neurological evolution at 24 hours
    9. The functional prognosis at 3 months
    10. All-cause mortality at 3 months
    11. Blood markers for thrombolysis
    12. The occurrence of adverse events and effects
    Évaluer chez les patients pris en charge pour un AVC ischémique par thrombolyse et éligibles à la thrombectomie, l’efficacité de l’administration IV de dornase alfa sur :
    1. Le taux de recanalisation précoce en angiographie pré-thrombectomie
    2. L’amélioration du taux de recanalisation entre le dernier passage de TM et une heure après l’administration de la dornase alfa (pour les procédure de TM <1h)
    3. La durée de la procédure de thrombectomie
    4. Le nombre de passages de thrombectomie
    5. La survenue d’un embole dans un nouveau territoire (ENT) en per-procédure de TM
    6. Le volume de l’infarctus cérébral final
    7. Taux de transformations hémorragiques à 24h
    8. L’évolution neurologique à 24h
    9. Le pronostic fonctionnel à 3 mois
    10. La mortalité toutes causes à 3 mois
    11. Les marqueurs sanguins de thrombolyse
    12. La survenue d’évènements et effets indésirables
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient over 18 years of age
    2. Ischemic stroke by proximal intracranial occlusion (internal carotid artery, middle cerebral artery in its M1 or M2 segment) isolated from the anterior circulation eligible for cerebral thrombectomy.
    3. Transferred to the NRI block of Hôpital Fondation A. de Rothschild as an emergency for a cerebral thrombectomy.
    4. Treated with IV thrombolysis (Aleplase or Tenecteplase) according to the European Stroke Organisation (ESO) 2021 guidelines with a bolus performed less than 90 minutes before inclusion.
    5. With a DWI-ASPECT score ≥ 5 on initial brain MRI
    6. Having received informed information about the study and consent to participate in the trial (if it is impossible to provide the information and to obtain consent to participate from the person consenting to the research, the information and the consent must be obtained from the trusted person or a family member if present, by way of exception, the inclusion may be made by the doctor following an emergency inclusion procedure).
    7. Member or beneficiary of a social health assurance
    1. Patient âgé de plus de 18 ans
    2. AVC ischémique par occlusion intracrânienne proximale (artère carotide interne ou artère cérébrale moyenne dans son segment M1) isolée de la circulation antérieure éligible à la thrombectomie cérébrale.
    3. Transféré au bloc de NRI de l’hôpital Fondation Adolphe de Rothschild en urgence pour la réalisation d’une thrombectomie cérébrale.
    4. Traité par thrombolyse IV (Aleplase ou Tenecteplase) selon les recommandations 2021 de l’European Stroke Organisation (ESO) avec un bolus réalisé moins de 90 minutes avant l’inclusion.
    5. Présentant un score DWI-ASPECT ≥ 5 à l’IRM cérébrale initiale
    6. Ayant reçu une information éclairée sur l’étude et ayant signé un consentement de participation à l’étude (en cas d’impossibilité de délivrer l’information et de recueillir le consentement de participation de la personne se prêtant à la recherche, l’information et le recueil du consentement doit être fait auprès de la personne de confiance ou d’un membre de la famille si présent, à titre dérogatoire l’inclusion pourra être faite par le médecin suivant une procédure d’inclusion en urgence)
    7. Affilié ou bénéficiaire d’un régime de sécurité sociale
    E.4Principal exclusion criteria
    1. Patient benefiting from a legal protection measure
    2. Pregnant or breastfeeding woman
    3. Known allergy to Dornase alfa (Pulmozyme®) or one of its excipients.
    4. Patients included in this study are not allowed to participate in other interventional clinical research.
    1. Patient bénéficiant d’une mesure de protection juridique
    2. Femme enceinte ou allaitant
    3. Allergie connue à la Dornase alfa (Pulmozyme®) ou à l’un de ses excipients.
    4. Les patients inclus dans cette étude ne sont pas autorisés à participer à d’autres recherches cliniques interventionnelles.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Complete recanalization defined by an mTICI 2C or 3 score (Appendix 1) at cerebral angiography one hour after the start of pulmozyme administration or at the end of the thrombectomy procedure (if procedure >1h).
    Recanalisation complète définie par un score de mTICI 2C ou 3 (Annexe 1) à l’angiographie cérébrale une heure après le début de l’administration de pulmozyme ou en fin de procédure de thrombectomie (si procédure >1h).
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 1
    jour 1
    E.5.2Secondary end point(s)
    Early recanalisation defined by a score of TICI 2b, 2c or 3 on pre-thrombectomy cerebral angiography
    2. Improvement of at least one grade in TICI score between cerebral angiography after the last pass of TM and that performed 1h after the start of dornase alfa infusion (for TM procedures <1h)
    3. Duration of the thrombectomy procedure defined as the time (in minutes) between the performance of the arterial puncture and recanalisation.
    4. Number of thrombectomy visits
    5. Intra-procedural ENT defined by the appearance on cerebral angiography of arterial occlusion in an initially unaffected territory during or at the end of TM.
    6. Cerebral infarct volume measured on cerebral MRI between 24 and 36 hours after thrombolysis
    7. Haemorrhagic transformation assessed on a 24-36 hour brain scan according to ECASS 3 (Appendix 2)
    8. Decrease in NIHSS score (Appendix 3) > 8 points between the pre-thrombolysis score and the score at 24-36h after thrombectomy
    9. Favourable functional prognosis at 3 months defined by a modified Rankin score of less than 3 (Appendix 4)
    10. All-cause death at 3 months after ischaemic stroke.
    11. Changes in blood thrombolysis marker concentrations (D-dimer, plasmin-antiplasmin complex, DNAse, fibrinogen degradation products, free DNA) between before Pulmozyme administration (sample taken on arrival of the patient in the NRI block) and after administration (sample taken at the end of the thrombectomy)
    12. Adverse events and serious/non-serious adverse reactions.
    1. Recanalisation précoce définie par un score de TICI 2b, 2c ou 3 à l’angiographie cérébrale en pré-thrombectomie
    2. Amélioration d’au moins un grade du score TICI entre l’angiographie cérébrale après le dernier passage de TM et celle réalisée 1h après le début de la perfusion de dornase alfa (pour les procédure de TM <1h)
    3. Durée de la procédure de thrombectomie définie par le délai (en minutes) entre la réalisation de la ponction artérielle et la recanalisation.
    4. Nombre de passages de thrombectomie
    5. Survenue en per-procédure d’un ENT défini par l’apparition à l’angiographie cérébrale d’une occlusion artérielle dans un territoire initialement non atteint en cours ou à la fin de la TM.
    6. Volume de l’infarctus cérébral mesuré à l’IRM cérébrale réalisée entre 24 et 36 heures après la thrombolyse
    7. Transformation hémorragique évaluée sur un scanner cérébral à 24h-36h selon l’échelle ECASS 3 (Annexe 2)
    8. Diminution du score NIHSS (Annexe 3) > 8 points entre le score pré-thrombolyse et le score à 24-36h de la thrombectomie
    9. Pronostic fonctionnel favorable à 3 mois défini par un score de Rankin modifié inférieur à 3 (Annexe 4)
    10. Décès toutes causes à 3 mois de l’AVC ischémique.
    11. Evolution des concentrations des marqueurs sanguins de thrombolyse (D-dimères, complexe plasmine-antiplasmine, DNAse, produits de dégradation du fibrinogène, ADN libre) entre avant l’administration du Pulmozyme (prélèvement à l’arrivée du patient au bloc NRI) et après l’administration (prélèvement en fin de thrombectomie).
    12. Évènements indésirables et effets indésirables graves/non graves.
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 1 and month 3
    jour 1 et 3 mois
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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.8.5The 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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    dernière visite dernier patient
    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 months15
    E.8.9.1In the Member State concerned days
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state44
    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)
    none
    aucun
    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 Decision2021-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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