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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2012-001863-64
    Sponsor's Protocol Code Number:AP301-II-001
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-31
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-001863-64
    A.3Full title of the trial
    Proof of concept study in male and female intensive care patients to investigate the clinical effect of repetitive orally inhaled doses of AP301 on alveolar liquid clearance in acute lung injury
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Proof of concept study in male and female intensive care patients to investigate the clinical effect of repetitive orally inhaled doses of AP301 on alveolar liquid clearance in acute lung injury
    A.4.1Sponsor's protocol code numberAP301-II-001
    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 SponsorApeptico Forschung und Entwicklung GmbH
    B.1.3.4CountryAustria
    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 supportApeptico Forschung und Entwicklung GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationApeptico Forschung und Entwicklung GmbH
    B.5.2Functional name of contact point
    B.5.3 Address:
    B.5.3.1Street AddressMariahilfer Staße 136, Top 1.15
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1150
    B.5.3.4CountryAustria
    B.5.4Telephone number00436641432919
    B.5.5Fax number0043125330337795
    B.5.6E-mailb.fischer@apeptico.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/3/09/677
    D.3 Description of the IMP
    D.3.1Product nameAP301
    D.3.4Pharmaceutical form Powder for nebuliser solution
    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.3.9.1CAS number 8000019-76-3
    D.3.9.2Current sponsor codeAP301
    D.3.9.3Other descriptive namehuman tumour necrosis factor alpha-derived peptide Cys-Gly-Gln-Arg-Glu-Thr-Pro-Glu-Gly-Ala-Glu-Ala-Lys-Pro-Trp-Tyr-Cys
    D.3.9.4EV Substance CodeSUB14950MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboNebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Pulmonary oedema
    E.1.1.1Medical condition in easily understood language
    Acute Lung Injury
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of orally inhaled AP301 on alveolar liquid clearance in ALI patients with the purpose to assess the treatment associated changes of extravascular lung water (EVLW) within 7 days of treatment.
    E.2.2Secondary objectives of the trial
    To assess:
    • the treatment associated changes of oxygenation as measured by the PaO2 / FiO2 ratio until day 7 of therapy,
    • the ventilatory plateau pressure and other ventilation parameters (Tidal volume, positive endexpiratory pressure, PIP, FiO2, respiratory rate, mean airway pressure and peak airway pressure) until day 7 of therapy,
    • the Murray lung injury score (a composite variable that includes components of oxygenation, compliance, positive end-expiratory pressure, and the appearance of the chest radiograph),
    • the duration of stay at ICU in the first 28 days,
    • the duration of controlled ventilation period until extubation,
    • number of days free from ventilatory support [for > 48 h] in the first 28 days
    • the survival status at day 28,
    • the local and systemic safety and tolerability and to identify possible dose related adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age ≥ 18
    - intubated and mechanically ventilated male and female patients of the Intensive Care Units of the Department of Anesthesia, General Intensive Care and Pain Control
    - meets the criteria of ALI (as defined by the American-European Consensus Conference on ALI/ ARDS):
    - Onset of ALI within 48 hours
    - Bilateral infiltrates seen on frontal chest radiograph
    - PCWP ≤ 18 mm Hg or no clinical evidence of left atrial hypertension
    - paO2/ FiO2 ratio ≤ 300 mm Hg

    - EVLW in PiCCO® at screening ≥ 8 ml/PBW
    - Meeting criteria for extensive hemodynamic monitoring according to investigators discretion
    - Informed consent:
    - For patients that are temporarily unable to consent (e.g. comatose patients) a subsequent informed consent has to be provided.
    E.4Principal exclusion criteria
    Medical Issues
    • History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product
    • Brainstem death at screening
    • Current evidence of septic shock as defined by the Surviving Sepsis Campaign (Presence of acute organ dysfunction secondary to infection plus hypotension with systolic blood pressure < 90 mm Hg or mean arterial pressure (MAP) < 70 mm Hg for not less than one hour which cannot be reversed with fluid resuscitation)
    • Neutrophil count <0.3 x 10^9 L
    • Patients under immunosuppression: high dose steroids (> 80 mg Prednisolone /d; > 300 mg hydrocortisone / d), cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks
    • BMI < 18.5 or > 35
    • Pregnancy / lactation or intention to fall pregnant during the time course of the study
    • Women of childbearing potential who are not using adequate contraception

    General Issues
    • Participation in other interventional drug trials
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint is EVWL (measured with PiCCO® technique) between day 0 and day 7 of treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    from baseline to day 7
    E.5.2Secondary end point(s)
    • Oxygenation index (PaO2 / FiO2 ratio) until day 7 of treatment
    • Ventilator plateau pressure until day 7 of treatment
    • Murray Lung Injury Score until day 7 of treatment
    • Ventilation parameters / lung function: tidal volume (Vt), positive endexpiratory pressure (PEEP), PIP, respiratory rate, FiO2 , meak airway pressure, peak airway pressure until day 7 of treatment
    • Duration of stay at ICU in the first 28 days
    • Duration of controlled ventilation period until extubation
    • Number of days free from ventilation support (for > 48 h) in the first 28 days
    • Survival status at day 28
    • the local and systemic safety and tolerability and to identify possible dose related adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline to day 7 respectively day 28 (+7)
    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 Yes
    E.8.1.7.1Other trial design description
    stratified
    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 concerned1
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 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
    Subjects are incapable of giving consent for reasons linked to their medical condition. They have Acute Lung Injury and are connected to a ventilator.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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 Decision2012-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
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