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    Summary
    EudraCT Number:2011-006131-38
    Sponsor's Protocol Code Number:CDEB025A2312
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-13
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-006131-38
    A.3Full title of the trial
    A multi-centre long term follow-up study to assess the durability of sustained virologic response in alisporivir-treated chronic hepatitis C patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long term follow-up study of chronic hepatitis C patients treated with alisporivir to assess durability of sustained virologic response
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberCDEB025A2312
    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 Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Hungary Kft. Pharma
    B.5.2Functional name of contact pointPublic Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressBartók Béla út 43-47.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1114
    B.5.3.4CountryHungary
    B.5.4Telephone number+361457-6500
    B.5.5Fax number+361457-6600
    B.5.6E-mailinfoph.hungary@novartis.com
    D. IMP Identification
    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
    Chronic hepatitis C in patients who achieved sustained virologic response (SVR24) on alisporivir in a Novartis-sponsored chronic Hepatitis C study.
    E.1.1.1Medical condition in easily understood language
    Chronic hepatitis C in patients who achieved sustained virologic response on alisporivir in a previous Novartis-sponsored trial.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10008912
    E.1.2Term Chronic 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 durability of sustained virologic response after SVR24 has been achieved in patients treated with alisporivir in a Novartis-sponsored chronic Hepatitis C study.
    E.2.2Secondary objectives of the trial
    -To assess the impact of successful alisporivir treatment on the change in liver disease over time and to assess the development of hepatocellular carcinoma (HCC).
    -To assess the safety over time of previous alisporivir exposure.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Written informed consent must be obtained before any assessment is performed
    -Males or females must be aged 18 years or older
    -Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir
    -Have achieved SVR24
    -Be able to comply with visit schedule
    E.4Principal exclusion criteria
    -Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer
    -Use or planned use to start a new course of hepatitis C therapy
    E.5 End points
    E.5.1Primary end point(s)
    To examine the proportion of patients who maintain HCV RNA viral load below lower limit of quantification (LOQ) at each scheduled time point.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the 5 scheduled visits within three years.
    E.5.2Secondary end point(s)
    -HCV RNA viral load
    -The proportion of patients who normalize alanine aminotransferase (ALT)
    -Liver fibrosis evaluations using Fibrotest and elastography, and to monitor for any changes over time using ultrasound of the liver and spleen
    -The proportion of relapsed patients
    -The proportion of re-infected patients
    -The safety assessment will be based on the analyses of adverse events, vital signs and laboratory evaluations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the 5 scheduled visits within three years.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    To assess the durability of sustained virologic response in alisporivir-treated chronic hepatitis C patients by assessing HCV RNA levels at scheduled visits.
    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.8.2.4Number 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Belgium
    Canada
    France
    Italy
    Romania
    Argentina
    Australia
    Germany
    Hong Kong
    Hungary
    India
    Korea, Republic of
    Spain
    Thailand
    Mexico
    Poland
    Russian Federation
    Taiwan
    Turkey
    United Kingdom
    United States
    Vietnam
    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
    Last visit of the last consented patient.
    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 months0
    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 months0
    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: 650
    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 No
    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 2012-04-13. 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 state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 650
    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 routine follow-up tests with blood samplings at each scheduled visit. No treatment is involved.
    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 Decision2012-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-21
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    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
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