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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2010-020403-75
    Sponsor's Protocol Code Number:ACEmeVent-Pilot
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-16
    Trial results View 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 number2010-020403-75
    A.3Full title of the trial
    ACE inhibitor for lung protection during mechanical Ventilation for acute lung injury - pilot trial
    ACE-Hemmer zur Lungenprotektion bei beatmeten Patienten mit akutem Lungenversagen - Pilotstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ACE inhibitor for lung protection during mechanical Ventilation for acute lung injury - pilot trial
    ACE-Hemmer zur Lungenprotektion bei beatmeten Patienten mit akutem Lungenversagen - Pilotstudie
    A.3.2Name or abbreviated title of the trial where available
    ACEmeVent-Pilot
    A.4.1Sponsor's protocol code numberACEmeVent-Pilot
    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 SponsorUniversität Leipzig
    B.1.3.4CountryGermany
    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 supportBundesministerium für Bildung und Forschung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversität Leipzig, Department für Innere Medizin, Neurologie und Dermatologie
    B.5.2Functional name of contact pointAbteilung für Pneumologie
    B.5.3 Address:
    B.5.3.1Street AddressLiebigstr. 20
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04103
    B.5.3.4CountryGermany
    B.5.4Telephone number493419712600
    B.5.5Fax number493419712609
    B.5.6E-mailACEmeVent-Pilot@zks.uni-leipzig.de
    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 Enahexal
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    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 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
    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
    acute lung injury, ALI/ARDS
    akutes Lungenversagen, ALI, ARDS
    E.1.1.1Medical condition in easily understood language
    acute lung injury
    akutes Lungenversagen
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10069351
    E.1.2Term Acute lung injury
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety concerning renal functions and cardiovascular functions as well as the occurrence of severe adverse events.
    Further primary objective is efficacy of the treatment regarding the recovery of the lungs measured as ventilator free days.
    Die primären Zielkriterien der klinischen Prüfung im Hinblick auf die Sicherheit sind die Nierenfunktion, die kardiovaskulären Funktionen sowie das Auftreten schwerwiegender unerwünschter Ereignisse.
    Das primäre Zielkriterium in Bezug auf die Bewertung der Wirksamkeit ist die Beatmungsdauer bei Patienten mit ALI/ARDS. Anhand der beatmungsfreien Tage soll die Regeneration der Lunge ermittelt werden.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    - mortality on day 28 and day 60 after start of trial therapy
    - state of ventilation on day 28
    - organ-failure free days until day 28
    - highest SOFA-Score during treatment and max. until day 28
    - days outside ICU (until day 28)
    - changes in oxygenation (PaO2/FiO2)
    Die sekundären Zielkriterien dienen dazu zu ermitteln, ob die Prüftherapie Einfluss hat auf
    - die Mortalität an Tag 28 und Tag 60 nach Therapiebeginn
    - den Beatmungsstatus an Tag 28
    - die Anzahl Tage ohne Organversagen bis Tag 28
    - den höchsten SOFA-Score-Wert während der Behandlung auf der Intensivstation und maximal bis Tag 28
    - Tage außerhalb der Intensivstation (bis Tag 28)
    - Veränderungen der Oxygenierung (PaO2/FiO2)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. invasive mechanical ventilation and begin of ventilation dates back a maximum of 60 hours
    2. acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) defined by
    a. sudden beginn of pulmonary failure
    and
    b. PaO2/FiO2 ≤ 300 mmHg (ARDS: PaO2/FiO2 ≤ 200 mmHg)
    and
    c. bilateral pulmonary shadows apparent on chest x-ray which are conformable with a edema
    and
    d. exclusion of a left cardiac insufficiency as source of the edema, i.e. pumonary closing pressure ≤18mmHg, if measured or absent signs of a clinically manifest left cardiac insufficiency.
    3. Age at least 18 years
    4. written informed consent by patient or legal or authorized representative
    1.Vorliegen invasiver mechanischer Beatmung und Beatmungsbeginn liegt nicht länger als 60 Stunden zurück
    2.akutes Lungenversagen (acute lung injury (ALI) / acute respiratory distress syndrome (ARDS)) definiert durch:
    a.plötzliches Einsetzen des Lungenversagens
    und
    b.PaO2/FiO2 ≤ 300 mmHg (ARDS: PaO2/FiO2 ≤ 200 mmHg)
    und
    c.bilaterale pulmonale Verschattungen in der Thoraxaufnahme, die mit einem Ödem vereinbar sind
    und
    d.den Ausschluss einer Linksherzinsuffizienz als Ursache dieses Zustandes, d.h. pulmonaler kapillärer Verschlussdruck ≤18mmHg, falls gemessen, oder fehlende Zeichen einer klinisch manifesten Linksherzinsuffizienz.
    3.Alter mindestens 18 Jahre
    4.schriftliche Einwilligungserklärung durch Patienten oder dessen gesetzlichen Betreuer oder Bevollmächtigten
    E.4Principal exclusion criteria
    1. positive pregnancy test in women with childbearing potential
    2. nursing women
    3. unsuggestive of elevatetd intracraniell pressure
    4. unsuggestive of neuromuscular diseases, if they are likely to affect spontaneous breathing
    5. known sickle cell anaemia
    6. severe chronic respiratory insufficiency in pre-existing pulmonary disease
    7. severe adiposity > 45 kg/qm
    8. burns of more than 30% of the body surface area
    9. other medical conditions with an expected 6-months mortality >50%
    10. Patients
    a. after bone marrow- or stem cell transplant in the past 12 months
    b. lung transplant
    11. liver cirrhosis Child Pugh C
    12. contraindications following the SmPC except for renal function disorders and renal replacement therapy
    13. Participation in another interventional clinical trials
    14. advanced relations to investigator
    1. Positiver Schwangerschaftstest bei Frauen im gebärfähigen Alter.
    2. Stillende Frauen
    3. Hinweise auf erhöhten intrakraniellen Druck
    4. Hinweise auf neuromuskuläre Erkrankungen, sofern sie die Spontanatmung beeinträchtigen
    5. Bekannte Sichelzellanämie
    6. Schwere chronische respiratorische Insuffizienz bei vorbestehender Lungenerkrankung
    7. Schwere Adipositas mit einem BMI > 45 kg/qm
    8. Verbrennung von mehr als 30% der Körperoberfläche
    9. Andere Situationen, in denen die erwartete 6-Monatssterblichkeit über 50% liegt
    10. Patienten
    a. nach Knochenmarks- oder Stammzelltransplantation in den letzten 12 Monaten
    b. nach Lungentransplantation
    11. Leberzirrhose Child Pugh C
    12. Kontraindikation bzw. Gegenanzeigen gemäß Fachinformation mit Ausnahmen bzgl. der Nierenfunktionsstörung und Nierenersatztherapie
    13. Die Teilnahme an einer anderen interventionellen klinischen Prüfung.
    14. weitergehende Beziehung zum Prüfarzt (z.B. Mitarbeiter, Verwandte, Kollegen)
    15. vorbekanntes nephrotisches Syndrom mit Proteinurie von mehr als 1 g/Tag
    16. klinisch relevante Elektrolytstörungen nach Einschätzung des behandelnden Prüfarztes
    17. Bekannte gestörte Immunreaktion oder Kollagenkrankheit (z. B. Lupus erythematodes, Sklerodermie)
    18. gleichzeitige systemische Therapie mit Arzneimitteln, die die Abwehrreaktionen unterdrücken (z. B. Kortikoide, Zytostatika, Antimetabolite, Allopurinol, Procainamid oder Lithium) mit Ausnahme der leitliniengerechten Behandlung von vorbestehenden Erkrankungen oder der Sepsis mit Glukokortikoiden.
    E.5 End points
    E.5.1Primary end point(s)
    primary endpoints of safety:
    - renal replacement therapy free days (RRTFD) until day 28
    - chronic renal replacement therapy (RRTc) on day 60
    - Change in renal function (CREA) until day 28 (ADDITIONAL endpoint since Amendment 03)
    - mean fluid balance (mean FB) until day 5
    - vasoactive substance free days (VASFD) until day 28
    - maximum and mean SOFA-Subscore cardiovascular function (maxSOFA-CV, mean SOFA-CV) until day 28
    - vasopressor dose (VD) until day 28
    - any serious adverse event

    primary endpoint of efficacy:
    - ventilator free days (VFD) until day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    please see E.5.1
    E.5.2Secondary end point(s)
    1. survival on day 28 and day 60 after randomisation (SV)
    2. Breathing without assistance (BWA), this efficacy end point is measured in two variants:
    a. proportion of patients breathing with assistance (on day 28) and alive on day 28
    b. proportion of patients breathing with assistance (on day 28) and who died and who are evaluable (according to trial protocol)
    1. Überleben an Tag 28 und Tag 60 nach Randomisation (SV)
    2. Beatmungsstatus an Tag 28 (BWA),
    Dieser Wirksamkeitssendpunkt wird in zwei Varianten analysiert:
    a. Anteil der beatmeten Patienten (an Tag 28) unter den Patienten, die am Tag 28 leben
    b. Anteil der beatmeten Patienten (an Tag 28) und der verstorbenen Patienten (bis Tag 28) unter den auswertbaren Patienten
    3. Anzahl Tage ohne Organversagen bis Tag 28 (mit Ausnahme der Lunge) (OFD)
    4. Höchster SOFA-Score-Wert bis Tag 28 (maxSOFA)
    5. Tage außerhalb der Intensivstation bis Tag 28 (ICUFD)
    Es wird jeder volle Lebenstag zwischen Tag 0 und Tag 28 gezählt, an welchem der Patient außerhalb der Intensivstation war.
    6. Veränderungen der Oxygenierung bis Tag 28 anhand PaO2/FiO2 – Ratio (OXY) und SOFA Subscore der Lunge (SOFA-OXY)
    E.5.2.1Timepoint(s) of evaluation of this end point
    please see E.5.2
    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) 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 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 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 concerned10
    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
    Data entry and data cleaning are planned to take place three months after the last follow-up visit of the last patient.
    After that the database will be closed and for the biometric analyses six months are scheduled.
    After that, the trial formally ends.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 No
    F.3.3Specific vulnerable populations Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Due to their medical condition most of the patients eligible for this trial will already be unable to give informed consent personally.
    Die für diese Studie geeigneten Patienten sind voraussichtlich größtenteils aufgrund der Indikation nicht in der Lage selbst einzuwilligen.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state210
    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 is no plan for treatment or care after the subject has ended the participation in the trial.
    Eine spezifische Nachbetreuung ist nicht vorgesehen. Bei der Studienintervention handelt es sich um eine intensivmedizinische Maßnahme, die für die anschließende medizinische Betreuung keine Konsequenzen hat.
    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 Decision2011-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-17
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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