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    Summary
    EudraCT Number:2011-001096-39
    Sponsor's Protocol Code Number:MV25600
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-30
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2011-001096-39
    A.3Full title of the trial
    An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes with Chronic Hepatitis C Disease Characteristics and Patient Demographics
    Medzinárodné, multicentrické klinické skúšanie hodnotiace koreláciu genotypov IL28B s demografickými údajmi pacientov a charakteristikou ochorenia u pacientov s chronickou hepatitídou C
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study with many of countries and sites participating. This study wants to look into the relationship of the genotype IL28B in patients from all over the world which are suffering from an inflammation of the liver with hepatitis C virus
    A.4.1Sponsor's protocol code numberMV25600
    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 SponsorF.Hoffmann-La Roche Ltd.
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel, Switzerland
    B.5.3.3Post code4070
    B.5.4Telephone number004161688 1111
    B.5.5Fax number004161691 9319
    B.5.6E-mailglobal.rochegenentechtrials@roche.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
    E.1.1.1Medical condition in easily understood language
    Inflammation of the liver caused by infection with Hepatitis C virus
    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 LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019752
    E.1.2Term Hepatitis C virus (HCV)
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Correlation of Interleukin 28B (IL28B) genotypes
    rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG) with liver fibrosis related to CHC
    E.2.2Secondary objectives of the trial
    - Correlation of IL28B genotypes (rs12979860 and
    rs8099917) with liver inflammation related to CHC
    - Correlation of IL28B genotypes (rs12979860 and
    rs8099917) with demographics in patients with CHC
    - Distribution of IL28B genotypes (rs12979860 and
    rs8099917) in patients with CHC in different HCV
    genotypes and in different countries
    - Correlation between the two IL28B genotypes
    (rs12979860 and rs8099917) in patients with CHC
    - Distribution of inosine triphosphatase (ITPA) genotypes rs1127354 (AA vs. CA vs. CC) and rs7270101 (CC vs. AC vs. AA) in patients with CHC in different HCV genotypes and in different countries
    - In treatment experienced patients, retrospective
    analysis of
    - Correlation between IL28B genotypes (rs12979860
    and rs8099917) and previous treatment outcome
    - Correlation between ITPA genotypes (rs1127354 and rs7270101) and hemoglobin (Hb) decline during prior treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult (according to local legislation) male or female
    patients
    - Chronic hepatitis C (CHC)
    - Patients naïve to CHC treatment or patients who
    received prior interferon (IFN) based therapy for CHC
    for whom data on treatment received (type of therapy, dose, duration) and treatment outcome (i.e. rapid virological response [RVR], complete early virological response [cEVR], partial early virological response [pEVR], end of treatment response [EoT), sustained virological response [SVR], relapse, breakthrough, nonresponse) of prior therapy is available. In addition information on fibrosis stage prior to the previous treatment course is required.
    - Written informed consent
    E.4Principal exclusion criteria
    - Co-infection with hepatitis B
    - History or other evidence of decompensated liver
    disease
    - History of major organ transplantation with an existing functional graft (including liver transplantation)
    - End stage renal disease
    E.5 End points
    E.5.1Primary end point(s)
    IL28B genotypes rs12979860 (CC vs. TC vs. TT) and rs8099917 (TT vs. GT vs. GG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to protocol MV25600, Section 5, Schedule of Assessments and Procedures
    E.5.2Secondary end point(s)
    ITPA genotypes rs1127354 (AA vs. CA vs. CC) and rs7270101 (CC vs. AC vs. AA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to protocol MV25600, Section 5, Schedule of Assessments and Procedures
    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 Yes
    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 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 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 EEA170
    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
    Argentina
    Chile
    Lebanon
    Mexico
    Pakistan
    Serbia
    Syria
    Taiwan
    Thailand
    Turkey
    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
    The end of the study is defined as last patient last visit. Last patient last visit is the date at which the last data point from the last patient, which is required for statistical analysis was received.
    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 months8
    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 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.1.1.1In 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.1.3Elderly (>=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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2573
    F.4.2.2In the whole clinical trial 4200
    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 Decision2012-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-10
    P. End of Trial
    P.End of Trial StatusOngoing
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