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    The EU Clinical Trials Register currently displays   35513   clinical trials with a EudraCT protocol, of which   5839   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:2005-003809-86
    Sponsor's Protocol Code Number:AUO 0105
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-05-21
    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 ConcernedAustria - BASG
    A.2EudraCT number2005-003809-86
    A.3Full title of the trial
    Phase II-Studie über die Ablative Wirkung von Immucothel 20mg beim oberflächlichen papillären Harnblasenkarzinom pTa /pT1 mit einer Markerläsion
    A.4.1Sponsor's protocol code numberAUO 0105
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorArbeitskreis für urologische Onkologie der österr. Gesellschaft für Urologie und Andrologie (AUO)
    B.1.3.4CountryAustria
    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 support
    B.4.2Country
    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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    Intravesical 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Primäres oder rezidivierendes multiples Ta, T1-Übergangszellkarzinom der Blase
    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
    Untersuchung der ablativen Wirkung von IMMUCOTHEL® (20 mg) intravesikal auf papilläre Ta, T1-Übergangszellkarzinom-Markertumoren. Zielkriterium der Studie ist die Responserate des Markertumors innerhalb von 3 Monaten nach Therapiebeginn. Es wird eine vollständige Responserate von mindestens 60 % erwartet
    E.2.2Secondary objectives of the trial
    Toxizität
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Primäres oder rezidivierendes multiples Ta, T1-Übergangszellkarzinom der Blase
    Multiple Tumoren, allerdings nicht mehr als 7
    Der Durchmesse des Markertumors sollte max. 1cm betragen
    Die histologische Differenzierung der anderen bei Studieneintitt entfernten Tumoren sollte entweder G1 oder G2 entsprechen
    Alle erkennbaren Läsionen müssen mittels transurethraler Resektion vollständig entfernt werden, ausgenommen einer unberührten Markerläsion mit einem max. Durchmesser von 1,0 cm. Zur Ermittlung der Größe des Tumors wird empfohlen, die Größe der Resektionsschleife als Bezugsgröße zu nehmen. Diese beträgt für eine Schleife von 22 French (7,3 mm) 0,8 cm. Das entfernte Gewebe muss Muskelgewebe aufweisen
    Der Patient/die Patientin muss seine/ihre schriftliche und mündliche Einwilligung gegeben haben
    Alter ≤ 80a
    E.4Principal exclusion criteria
    Patienten mit solitärer Läsion
    Patienten mit mehr als 7 multiplen Tumoren
    Patienten mit Grad-3-Tumoren
    Patienten mit muskelinvasiven Tumoren (≥ T2)
    Patienten mit CIS bei Studieneintritt
    Zuvor mit KLH behandelte Patienten
    Frühere lokale intravesikale Behandlung innerhalb von drei Monaten vor der Registrierung
    Frühere systemische Krebstherapie mittels Immuntherapie oder zytotoxischen Wirkstoffen
    Frühere Radiotherapie der Blase oder des Beckens
    Nicht kontrollierbarer Harnwegsinfekt
    Nicht behandelter Harnwegsinfekt oder schwere rezidivierende bakterielle Zystitis
    WHO-Performance-Status
    Andere Karzinomformen der Blase außer Übergangszellkarzinom bzw andere maligne Erkrankung ausgenommen Basaliome der Haut
    Übergangszellkarzinom der oberen Harnwege oder in der Pars prostatica urethrae
    Zu erwartende Schwierigkeiten bei der Nachbeobachtung anderweitiger Erkrankungen oder zu große Entfernung zwischen dem Wohnort des Patienten und dem Prüfzentrum
    Schwangerschaft und Stillzeit
    Leukozytenzahl unter 3 000 x 109/l oder Thrombozytenzahl unter 1 000 x 109/l vor Behandlungsbeginn
    Leber- und/oder Nierenfunktionsstörungen, bei denen die Werte über dem Doppelten des oberen Normalwertes des örtlichen Labors liegen
    Patienten mit angeborenen oder erworbenen Immunerkrankungen, Transplantatempfänger und Patienten mit bekanntem HIV-positiven serologischen Befund mit oder ohne klinisch manifester AIDS-Erkrankung
    E.5 End points
    E.5.1Primary end point(s)
    Der Response ist 2 Wochen (max. 3 Wochen) nach der letzten Instillation zu beurteilen. Resttumoren sind vollständig zu entfernen. Im Falle eines vollständigen Verschwindens des Markers ist der Tumorbereich zu biopsieren. Die Biopsieprobe muss Muskelgewebe enthalten
    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 Information not present in EudraCT
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state57
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    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 Decision2008-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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