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    Summary
    EudraCT Number:2011-003559-21
    Sponsor's Protocol Code Number:CDEB025A2212
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-02
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-003559-21
    A.3Full title of the trial
    A Retrospective Pharmacogenetic Analysis of Hepatitis C Patients treated with Alisporivir (DEB025) Alone or in Combination with Peg-IFN2a and/or Ribavirin
    Analisi Farmacogenetica Retrospettiva dei Pazienti con Epatite C trattati con Alisporivir (DEB025) in Monoterapia o in Associazione a PEG-IFN-alfa2a e/o ribavirina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacogenetic analysis study of hepatitis C patients treated with DEB025/Alisporivir alone or with Peg-IFN2a and/or Ribavirin
    Analisi Farmacogenetica Retrospettiva dei Pazienti con Epatite C trattati con Alisporivir (DEB025) in Monoterapia o in Associazione a PEG-IFN-alfa2a e/o ribavirina
    A.4.1Sponsor's protocol code numberCDEB025A2212
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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 supportNovartis
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 96541
    B.5.5Fax number+39 029659066
    B.5.6E-mailinfo.studiclinici@novartis.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAlisporivir
    D.3.2Product code DEB025A
    D.3.4Pharmaceutical form Capsule, soft
    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 INNAlisporivir
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Hepatitis C and how biomarkers affect the response to treatment of the disease
    Epatite C e come i biomarkers possano avere un'influenza sulla risposta al trattamento della malattia
    E.1.1.1Medical condition in easily understood language
    Hepatitis C and how biomarkers affect the response to treatment of the disease
    Epatite C e come i biomarcatori possano avere un'influenza sulla risposta al trattamento della malattia
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 impact of potential markers (or polymorphisms) in host genes from patients in studies DEB-025-103, DEB-025-HCV-203 and DEB-025-HCV-205 on the PK profile, safety, and efficacy of alisporivir alone or in combination with peg-IFN-2a and ribavirin. These potential markers may include variants in cytochrome P450 isoenzymes 2D6 and 3A5, transporters such as P-gp, UGT1A1, cyclophilin A and B, IL28B, among others.
    • Analizzare gli effetti delle differenze genetiche individuali sulla risposta virologica precoce dopo 2 e 4 settimane di alisporivir in monoterapia, rispettivamente per i pazienti che hanno partecipato agli studi DEB-025-103 e DEB-025-HCV-203 • Analizzare gli effetti delle differenze genetiche individuali sulla risposta virologica sostenuta nei pazienti trattati con PEG-IFN-alfa2a e ribavirina per 24 o 48 settimane nello studio DEB-025-205
    E.2.2Secondary objectives of the trial
    None
    nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must have completed studies DEB-025-103, DEB-025-HCV-203 and DEB-025-HCV-205. Written informed consent must be obtained prior to any assessments being performed.
    • Consenso informato scritto precedente a qualsiasi valutazione del paziente • Pazienti che abbiano completato uno dei seguenti studi: DEB-025-103, DEB-025-HCV-203, DEB-25-HCV-205
    E.4Principal exclusion criteria
    None
    nessuno
    E.5 End points
    E.5.1Primary end point(s)
    1) To examine the association of individual genetic variation on early viral response after 2 and 4 weeks of alisporivir monotherapy in DEB- 025-103 and DEB-025-HCV-203, respectively 2) To examine the association of individual genetic variation on SVR rate in patients treated with alisporivir in combination with Peg-IFN-2a and ribavirin for 24 or 48 weeks in DEB-025-205
    • Analizzare gli effetti delle differenze genetiche individuali sulla risposta virologica precoce dopo 2 e 4 settimane di alisporivir in monoterapia, rispettivamente per i pazienti che hanno partecipato agli studi DEB-025-103 e DEB-025-HCV-203 • Analizzare gli effetti delle differenze genetiche individuali sulla risposta virologica sostenuta nei pazienti trattati con PEG-IFN-alfa2a e ribavirina per 24 o 48 settimane nello studio DEB-025-205
    E.5.1.1Timepoint(s) of evaluation of this end point
    Retrospective pharmacogenetic analysis
    Analisi di farmacogenetica retrospettiva
    E.5.2Secondary end point(s)
    1)To examine the association of individual genetic variation on RVR, viral response at Week 12 and end of treatment response in patients treated with alisporivir in combination with Peg-IFN-2a and ribavirin in DEB-025-205 2)To examine the association of individual genetic variation on elevation of on-treatment bilirubin level in DEB-025-103, DEB-025-HCV-203 and DEB-025-HCV-205 3)To examine the association of individual genetic variation on pharmacokinetic property of alisporivir in DEB-025-103, DEB-025-HCV- 203 and DEB-025-HCV-205 4) To evaluate the durability of sustained virologic response by measuring HCV RNA in patients who completed DEB-025-HCV-205 5) To evaluate biochemical liver function of patients who completed DEB-025-HCV-205 to determine changes in liver disease over time
    1)per analizzare gli effetti delle differenze geneticche individuali sulla RVR, risposta virale alla settimana 12 e a fine trattamento in pazienti trattati con alisporivir congiuntamente a Peg-IFN-2a e ribavirina in DEB-025-205 2)per analizzare gli effetti delle differenze genetiche individuali sull'elevazione dei livelli della bilirubina in DEB-025-103, in DEB-025-HCV-203 e in DEB-025-HCV-205 3)per analizzare gli effetti delle differenze genetiche individuali sulla proprietà farmacocinetica di alisporivir in DEB-025-103, in DEB-025-HCV- 203 e in DEB-025-HCV-205 4) per analizzare la risposta virologica continua controllando HCV RNA in pazienti che hanno completato DEB-025-HCV-205 5) per valutare la funzione epatica dei pazienti che hanno completato DEB-025-HCV-205 per determinare col passare del tempo i cambiamenti nell'affezione epatica
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3) Retrospective pharmacogenetic analysis 4-5) At the time of sample analysis
    1-3) Analisi di farmacogenetica retrospettiva 4-5) Ai tempi dell'analisi del campione
    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 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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Optional HCV RNA analysis, liver function and hematology testing of pts from study DEB-025-HCV-205
    Analisi HCV RNA facoltativa, funzione epatica e test ematologici in pz dl studio DEB-025-HCV-205
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial0
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    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
    When all patients from studies DEB-025-103, DEB-025-HCV-203 and DEB-025-HCV-205 who consent to participate in this post-hoc pharmacogenetic analysis have provided blood samples over a 6 to 9 month recruitment period
    Quando tutti i pazienti coinvolti nei precedenti studi DEB-025-103, DEB-025-HCV-203 e DEB-025-HCV-205, che hanno acconsentito a partecipare a questo studio retrospettivo di farmacogenetica si saranno sottomessi al prelievo di sangue
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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: 237
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 277
    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. This study involves a single blood draw for a pharmacogenetic assessment with an optional additional blood draw for patients who completed study DEB-025-HCV-205. No treatment is involved.
    Nessuno. Questo studio prevvede soltanto un prelievo di sangue per l'analisi retrospettiva di farmacogenetica con un ulteriore prelievo di sangue facoltativo solo per i pazienti che hanno completato lo studio DEB-025-HCV-205. Non c'è nessun trattamento implicato.
    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 Decision2012-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-07
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