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    The EU Clinical Trials Register currently displays   36835   clinical trials with a EudraCT protocol, of which   6081   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-004993-15
    Sponsor's Protocol Code Number:MV21371
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-004993-15
    A.3Full title of the trial
    A Randomized, Open-Label, Multicenter Study Examining the Effects of 24 Versus 48 Weeks of Combination Therapy with PEGASYS® (Peginterferon alfa-2a 40KD) plus COPEGUS® (Ribavirin) on Sustained Virological Response in Patients with Chronic Hepatitis C, Genotype 2 or 3 who do not Achieve a Rapid Viral Response
    A.3.2Name or abbreviated title of the trial where available
    NCORE
    A.4.1Sponsor's protocol code numberMV21371
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, Welwyn Garden City, UK
    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 namePeginterferon alpha-2a
    D.3.2Product code Ro 25-8310/J13 & V01
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPeginterferon alfa-2a
    D.3.9.1CAS number 198153-51-4
    D.3.9.2Current sponsor codeRo 25-8310/J13 & V01
    D.3.9.3Other descriptive namepegylated interferon alfa-2a
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.2.1.1.1Trade name Copegus
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameCopegus
    D.3.2Product code Ro 20-9963/F06
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNRibavirin
    D.3.9.1CAS number 36791-04-5
    D.3.9.2Current sponsor codeRo 20-9963/F06
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Chronic hepatitis C
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD) plus COPEGUS® (ribavirin) combination therapy given for 24 weeks versus 48 weeks on the clearance of HCV viremia 24 weeks after treatment end (sustained virological response, SVR) in patients with chronic hepatitis C (CHC) virus infection and Genotype 2/3, who do not achieve a rapid viral response (RVR, defined as undetectable HCV RNA by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test ) at week 4 but have an early virological response at week 12 (EVR, defined as undetectable HCV RNA or a drop of ≥2-log10)
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of PEGASYS® plus COPEGUS® combination therapy given for
    24 weeks versus 48 weeks on the clearance of HCV viremia 72 weeks after
    treatment initiation (FDA request)
    • To compare the effect of PEGASYS® plus COPEGUS® given for 24 weeks versus 48
    weeks on end of treatment response and relapse rates
    • To evaluate prognostic factors for sustained virological response and relapse in
    the two randomized treatment groups
    • To compare the safety of PEGASYS® plus COPEGUS® given for 24 versus 48 weeks
    • To investigate the impact of the COPEGUS® starting dose (800 mg/d versus
    1000/1200 mg/d in combination with PEGASYS®) on virological response
    • To describe the safety of PEGASYS® plus COPEGUS® at a starting dose of 800
    mg/d versus 1000/1200 mg/d
    • Pharmacoeconomic evaluation and comparison of the two study arm
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female patients greater than or equal to 18 years of age at treatment initiation

    Serologic evidence of chronic hepatitis C (CHC) infection by an anti-HCV antibody test prior to therapy

    Patients with CHC genotype 2 or 3

    Patients in whom therapy with PEGASYS® plus COPEGUS® was initiated at the discretion of the investigator according to local standard of care with PEGASYS® 180µg/week plus COPEGUS® 800 mg/d or 1000/1200 mg/d adhering to the sections: “Contraindications” and “Special Warnings and Precautions” of the current summaries of product characteristics (SPCs) / US Product Information (USPI) / local labeling (Please refer to the Investigator’s Folder for local labeling).

    Quantifiable Serum HCV RNA >43 IU/mL by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test within 3 months prior to treatment initiation with PEGASYS® plus COPEGUS®

    Detectable Serum HCV RNA by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after 4 weeks of treatment with PEGASYS® plus COPEGUS® (i.e. 21 to 35 days after start of treatment)

    Information on PEGASYS® and COPEGUS® compliance including dose modifications and treatment interruptions during the first 6-8 weeks of treatment have to be available and are documented in the patient chart

    Patient must be able to comply with the adherence assessments during the study

    Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score less than or equal to 6)

    Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug (i.e. treatment week 6-8)

    All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment with study drugs and 7 months post treatment completion
    E.4Principal exclusion criteria
    Exclusion Criteria at Study Entry (treatment week 6-8)
    • Women with ongoing pregnancy or breast feeding
    • Male partners of women who are pregnant
    • Patients with CHC genotype 1
    • Pegylated interferon, standard interferon or ribavirin therapy at any time prior to
    initiation of the current therapy with PEGASYS® plus COPEGUS®
    • Any investigational drug within less than or equal to 6 weeks prior to the first dose
    of the current therapy with PEGASYS® plus COPEGUS®
    • Co-infection with hepatitis A, hepatitis B or human immunodeficiency virus (HIV)
    • History or other evidence of decompensated liver disease (Coagulopathy,
    hyperbilirubinemia, hepatic encephalopathy, hypo-albuminemia, ascites, and
    bleeding from esophageal varices are conditions consistent with
    decompensated liver disease)
    • Signs or symptoms of hepatocellular carcinoma
    • Not adequately controlled thyroid dysfunction, diabetes mellitus or psychiatric
    disorders
    • Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or
    clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or
    hypertension)
    • Any form of substance abuse (including excessive alcohol consumption) that
    precludes successful participation in the study at the discretion of the investigator
    • Inability or unwillingness to provide written informed consent or abide by the
    requirements of the study

    Exclusion Criteria at Randomization (treatment week 24):
    • Patients who did NOT achieve an early virological response at week 12 (EVR
    defined as undetectable HCV RNA or a drop of ≥2-log10 measured 71 to 98 days
    after start of treatment)
    • Neutrophil count <500 cells/mm3 or platelet count <25,000 cells/mm3 or
    hemoglobin <8.5 g/dL
    • Patients who discontinued study medication
    E.5 End points
    E.5.1Primary end point(s)
    Sustained virological response (SVR) defined as percentage of patients with undetectable HCV RNA as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 24 weeks post completion of the 24 and 48 week treatment periods (a single last undetectable HCV RNA PCR measured ≥day 308 after treatment initiation for patients not randomized or from group A and ≥day 477 for group B).
    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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    24 wks vs 48wks of Pegasys/Copegus treatment
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 study will be the date of the last visit of the last patient undergoing the study. Last patient, last visit is either the date of the last patient visit to complete the study or the date at which the last data point from the last patient, which is required for statistical analysis (i.e. key safety and efficacy results for decision making) was received, whichever is the later date.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 400
    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 Decision2008-08-26
    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 StatusCompleted
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