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    Summary
    EudraCT Number:2015-002882-41
    Sponsor's Protocol Code Number:AIBDSG_002
    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:2015-11-05
    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 ConcernedAustria - BASG
    A.2EudraCT number2015-002882-41
    A.3Full title of the trial
    Sono-­Response-­Study
    A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease
    Sono-Response-Studie
    Die Verwendung von Kontrastmittel-verstärktem Ultraschall bei Morbus Crohn
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Pilot Study on the use of contrast enhanced ultrasound in Crohn’s disease
    Die Verwendung von Kontrastmittel-verstärktem Ultraschall bei Morbus Crohn
    A.4.1Sponsor's protocol code numberAIBDSG_002
    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 SponsorMedical University of Vienna (MUW)
    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 supportUniversitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie
    B.5.2Functional name of contact pointWorking Party IBD
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+431404006245
    B.5.5Fax number+431404004735
    B.5.6E-mailchristian.primas@meduniwien.ac.at
    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 SonoVue
    D.2.1.1.2Name of the Marketing Authorisation holderBracco International B.V. Strawinskylaan 3051 NL - 1077 ZX Amsterdam Niederlande
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product nameSonoVue
    D.3.4Pharmaceutical form Gas and solvent for dispersion for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsulphur hexafluoride
    D.3.9.1CAS number 2551-62-4
    D.3.9.3Other descriptive nameSULFUR HEXAFLUORIDE
    D.3.9.4EV Substance CodeSUB15925MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µl/ml microlitre(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Inflammatory bowel disease (Crohn's disease)
    Chronisch entzündliche Darmerkrankungen (Morbus Crohn)
    E.1.1.1Medical condition in easily understood language
    chronic inflammatory bowel disease
    Chronisch entzündliche Darmerkrankungen
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the predicitve capacity of contrast enhanced ultrasound for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment (stratified by the Harvey Bradshaw Index in responders and non responders).
    Es soll die Vorhersagekraft von Kontrastmittel-verstärktem Ultraschall am Dünndarm zur Beurteilung des Ansprechens auf eine neu begonnen Therapie mit einem TNF-alpha-Blocker gezeigt werden (stratifiziert durch den Harvey Bradshaw Index in Responder und Non Responder).
    E.2.2Secondary objectives of the trial
    Assess the predictive capacity of CEUS for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment with biometrical parameters as stratifiers for response (fCP).
    Correlate results from CEUS with
    -­ MRI
    -­ Change of fecal calprotectin (Visit 1 versus Visit 2, 3 and 4)
    Correlate results form MRI with
    -­ Change in disease activity scores
    -­ Change of fecal calprotectin (Visit 1 versus Visit 2, 3 and 4)
    Bewertung der Vorhersagekraft von Kontrastmittel-verstärktem Ultraschall bei Patienten mit Morbus Crohn und neu begonnener Therapie mit einem TNF-alpha-Blocker durch biometrische Parameter.
    Korrelation der Ergebnisse des Kontrastmittel-verstärkten Ultraschalles mit
    - MRT
    - Veränderungen beim fäkalen Calprotectin (Visite 1 versus Visite 2, 3 und 4)
    Korrelation der Ergebnisse des MRT mit
    - Veränderungen im Aktivitätsscore
    - Veränderungen beim fäkalen Calprotectin (Visite 1 versus Visite 2, 3 und 4)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Men and women above the age of 18 with an established diagnosis of Crohn’s disease for at least 3
    months (according to a histology from an ileocolonoscopy evidentiary
    for Crohn’s disease)
    2) Able and willing to provide written informed consent
    3) Crohn’s disease with evidence
    of ileal or ileocolonic disease
    4) Clinically active disease as evidenced by a Harvey Bradshaw index of 8 or above
    5) Planned step-­‐up in immunosuppressive therapy with an antiTNFalpha agent
    1) Männer und Frauen mit einer seit mindestens drei Monaten etablierten Diagnose von Morbus Crohn (gemäß einer bei einer Ileocolonoskopie gewonnenen Histologie)
    2) Imstande und bereit einen Einvertsändnisbogen (Patienteninformation) zu unterschreiben.
    3) Vorliegen von ilealen oder ileocolonischen M. Crohn (abgesichert durch Bildgebung oder
    Histologie)
    4) Klinische Aktivität der Erkrankung gemessen an einem Werte von 8 oder mehr im Harvey Bradshaw Index
    5) Geplante Eskalation der Therapie zu einem TNF-alpha-Blocker.
    E.4Principal exclusion criteria
    1) Ulcerative colitis or indeterminate colitis
    2) Isolated colonic Crohn’s disease
    3) Contraindications for undergoing magnetic resonance imaging with computed tomography or other methods planned to be applied for disease/response assessment as substitute for MRI
    4) Contraindications to undergo contrast enhanced ultrasound examinations
    5) Contraindications against therapy with an antiTNFalpha agent
    6) Inability to adhere to follow up schedule and/or provide information necessary to assess response parameters
    7) Unwilling or unable to undergo blood sampling
    8) Female subjects pregnant or planning pregnancy within the timeframe of the study participation
    9) Significant coronary heart disease, right-to-­left, bidirectional, or transient right-­to-­left cardiac shunt
    1) Colitis ulceroca oder IBDU
    2) Rein colonischer M. Crohn
    3) Vorliegen von Kontraindikationen für die Durchführung einer MRT
    4) Vorliegen von Kontraindikationen für die Durchführung einer kontrastmittel-verstärkten Ultraschalluntersuchung
    5) Kontraindikationen gegen eine Therapie mit einem TNF-alpha-Blocker
    6) Unvermögen die vorgegebenen Abläufe einzuhalten und/oder Informationen zur Verfügung zu stellen, die zur Beurteilung des Ansprechens zu erheben sind
    7) Unwillig oder außerstandefür eine Blutabnahme
    8) Schwangere sowie Frauen, die eine Schwangerschaft im Zeitraum der klinischen Studie planen
    9) Relevante KHK, Rechts-zu-Links, bidirektionaler oder vorübergehender Shunt am Herzen
    E.5 End points
    E.5.1Primary end point(s)
    To assess the predicitve capacity of contrast enhanced ultrasound for response assessment in Crohn’s disease patients under newly established therapy with antiTNFalpha treatment, measured at week 12 (stratified by the Harvey Bradshaw Index in responders and non responders).
    Vorhersagekraft von Kontrastmittel-verstärktem Ultraschall am Dünndarm zur Beurteilung des Ansprechens auf eine neu begonnen Therapie mit einem TNF-alpha-Blocker, gemessen zu Woche 12 (stratifiziert durch den Harvey Bradshaw Index in Responder und Non Responder).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Woche 12
    E.5.2Secondary end point(s)
    Correlate results from CEUS with
    - MRI
    - Change of fecal calprotectin
    Correlate results form MRI with
    - Change in disease activity scores
    - Change of fecal calprotectin
    Korrelation der Ergebnisse des CEUS mit
    - MRT
    - Veränderungen im fäkalen Calprotectin
    Korrelation der Ergebnisse des MRT mit
    - Veränderungen der Krankheitsaktivität
    - Veränderungen im fäkalen Calprotectin
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 1 versus Visit 2 (week 4), 3 (week 12) and 4 (week 24)
    Visite 1 verglichen mit Visite 2 (Woche 4), 3 (Woche 12) und 4 (Woche 24)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned3
    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 No
    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
    Letzter Besuch des letzten Patienten
    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 months0
    E.8.9.1In the Member State concerned 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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 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 state25
    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
    Keine
    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 Decision2015-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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