Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43235   clinical trials with a EudraCT protocol, of which   7153   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-004681-15
    Sponsor's Protocol Code Number:KIMCL_TS_2011-09
    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:2011-10-19
    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 number2011-004681-15
    A.3Full title of the trial
    Effects of the activation of peroxisome proliferator-activated receptors in patients with primary biliary cirrhosis
    Wirkung von Aktivierung von Peroxisom-Proliferator-aktivierten Rezeptoren bei PatientInnen mit primär biliärer Cirrhose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of the activation of PPARs in the orphan hepatic disease primary biliary cirrhosis
    Wirkung von PPARs-Aktivierung auf die seltene Lebererkrankung primär biliäre Zirrhose
    A.3.2Name or abbreviated title of the trial where available
    Effects of the activation of PPARs in patients with PBC
    Wirkung von PPARs-Aktivierung bei PBC PatientInnen
    A.4.1Sponsor's protocol code numberKIMCL_TS_2011-09
    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 SponsorMedizinische Universität Graz
    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 supportMedical University of Graz, Clinical Institute of Medical and Chemical Laboratory Diagnostics
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointMUG
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 15
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number+43316385 80442
    B.5.5Fax number+43316385 13430
    B.5.6E-mailtatjana.stojakovic@medunigraz.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 Bezafibrat "Genericon" retard 400 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGenericon Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameBezafibrat
    D.3.2Product code 1-20190
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBEZAFIBRATE
    D.3.9.1CAS number 41859-67-0
    D.3.9.4EV Substance CodeSUB05810MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.IMP: 2
    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.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameUrsodeoxycholsäure
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 128-13-2
    D.3.9.3Other descriptive nameURSODEOXYCHOLIC ACID
    D.3.9.4EV Substance CodeSUB11389MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Up to 67% of PBC patients have an incomplete biochemical response to UDCA and remain at increased risk for progression to cirrhosis and liver-related death. In this study we will prospectively examine the therapeutic effects of bezafibrate (a pan-agonist activating PPARalpha/delta/gamma) in patients with early-stage PBC with a specific focus on improvement of liver functions, inflammation, lipid profile, oxidative status and endothelial function.
    Bis zu zwei Drittel der PBC PatientInnen sprechen nicht ausreichend auf UDCA an und weisen ein erhöhtes Risiko für eine Progression zur Leberzirrhose und dadurch bedingten Tod auf. In dieser prospektiven Studie sollen die therapeutischen Effekte von Bezafibrat (ein Panagonist, der PPARalpha/delta/gamma aktiviert) bei PatientInnen mit PBC im Frühstadium in Hinblick auf Verbesserung der Leberfunktion, Inflammation, Lipidprofil, oxidativer Status und Endothelfunktion untersucht werden.
    E.1.1.1Medical condition in easily understood language
    Up to 67% of PBC patients have an incomplete biochemical response to UDCA. Effects of bezafibrate will be examined with a specific focus on improvement of laboratory parameters and vascular function.
    Bis zu 2/3 der PBC PatientInnen sprechen nicht ausreichend auf UDCA an. Es sollen daher die Effekte von Bezafibrat in Hinblick auf Laborparameter und Gefäßfunktion untersucht werden.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    Our major hypothesis is that the treatment with bezafibrate will improve levels of AP in early-stage PBC patients with an incomplete biochemical response to UCDA through a combination of metabolic and anti-inflammatory effects.
    Unsere Hypothese ist, dass die Therapie mit Bezafibrat die AP bei PBC PatientInnen im Frühstadium und unzureichendem Ansprechen auf UCDA aufgrund metabolischer und anti-inflammatorischer Effekte vebessert.
    E.2.2Secondary objectives of the trial
    Moreover, we will focus on mechanistic effects on markers of liver function, chronic low-grade inflammation, dyslipidemia, oxidative stress and endothelial function.
    Desweiteren werden wir die mechanistischen Effekte in Bezug auf Leberfunktion, chronische niedriggradige Inflammation, Dyslipidämie, oxidativer Stress und Endothelfunktion untersuchen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Incomplete responders to standard UDCA therapy (AP > 1.5x ULN after one year)
    PBC stage I – II (biopsy proven and/or positive AMA)
    Male or female gender
    Age 18 – 70 years
    Normal kidney function
    Signed informed consent
    inkomplette Responder auf Standard UDCA Therapie (AP >1.5x ULN nach 1 Jahr)
    PBC Stadium I-II (entsprechende Leberhistologie und/oder AMA positiv)
    männliches oder weibliches Geschlecht
    Alter 18-70 Jahre
    normale Nierenfunktion
    schriftliche Einwilligung der PatientInnen
    E.4Principal exclusion criteria
    PBC stage III – IV
    Age > 70 years
    Decompensated liver disease (Child-Pugh class B/C, presence of ascites, esophageal varices)
    Cholelithiasis
    ALT or AST > 3x ULN
    CK > 5x ULN or CK >3x ULN with muscle pain, tenderness or weakness
    Pregnancy or breastfeeding
    Premenopausal women without certain contraception
    Known hypersensitivity to fibrates
    Current treatment with lipid-lowering drugs, immunosuppressants, coumarin-based anticoagulants, monoamine oxidase inhibitors
    PBC Stadium III-IV
    Alter >70 Jahre
    dekompensierte Lebererkrankung (Child-Pugh B/C, Ascites, Oesophagusvarizen)
    Cholelithiasis
    ALT oder AST >3x ULN
    CK >5x ULN oder CK >3x ULN mit Muskelschmerzen oder Muskelschwäche
    Schwangerschaft oder Stillen
    prämenopausale Frauen ohne sichere Kontrazeption
    bekannte Hypersensitivität gegenüber Fibraten
    laufende Behandlung mit lipidsenkenden Medikamenten, Immunsuppressiva, Antikoagulantien vom Cumarintyp, Monoaminooxidase-Hemmer
    E.5 End points
    E.5.1Primary end point(s)
    alkaline phosphatase (AP)
    alkalische Phosphatase (AP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening (within 4 weeks prior to baseline visit), at weeks 0 (baseline), 4, 8
    Screening (innerhalb 4 Wochen vor Baseline Visite), Woche 0 (Baseline), Woche 4, Woche 8
    E.5.2Secondary end point(s)
    Liver enzymes
    Composition and concentrations of VLDL, IDL, LDL and HDL particles
    Cholesterol precursors and metabolites
    Markers of inflammation and oxidative stress
    Vascular morphology and function
    Leberenzyme
    Zusammensetzung and Konzentration von VLDL, IDL, LDL und HDL Partikeln
    Cholesterinvorläufer und Metabolite
    Marker für Inflammation und oxidativen Stress
    Gefäßmorphologie und -funktion
    E.5.2.1Timepoint(s) of evaluation of this end point
    Liver enzymes at screening, at weeks 0, 4, 8
    Composition and concentrations of VLDL, IDL, LDL and HDL particles at weeks 0, 4, 8
    Cholesterol precursors and metabolites at weeks 0, 4, 8
    Markers of inflammation and oxidative stress at weeks 0, 4, 8
    Vascular morphology and function at weeks 0, 8
    Leberenzyme: Screening, Woche 0, 4, 8
    Zusammensetzung and Konzentration von VLDL, IDL, LDL and HDL Partikeln: Woche 0, 4, 8
    Cholesterinvorläufer und Metabolite: Woche 0, 4, 8
    Marker für Inflammation und oxidativen Stress: Woche 0, 4, 8
    Gefäßmorphologie und -funktion: Woche 0, 4, 8
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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.8.4.1Number 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 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
    End of the trial = last patient out
    Ende der Studie = letzte(r) PatientIn abgeschlossen
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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.1.1.1In 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    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)
    After the end or discontinuation of the trial the patient will be further supervised in the liver clinic. Depending on the findings of this trial a follow-up study to investigate the long-term efficacy and safety of bezafibrate in PBC will be planned.
    Nach Abschluß bzw. bei vorzeitiger Beendigung der Studie wird der/die PatientIn in der Leberambulanz weiterbetreut. Abhängig von den Ergebnissen dieser Studie ist eine Folgestudie geplant, bei der die Sicherheit und Wirksamkeit von Bezafibrat bei PBC näher untersucht werden soll.
    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 Decision2011-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-14
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2023 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA