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    Summary
    EudraCT Number:2011-000416-25
    Sponsor's Protocol Code Number:TMC435-TiDP16-C213
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-22
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-000416-25
    A.3Full title of the trial
    A Phase III, open-label trial of TMC435 in combination with peginterferon alpha-2a and ribavirin for HCV genotype-1 infected subjects who participated in the placebo group of a Phase II/III TMC435 study (C201, C205, C206, C208, C216 or HPC3007), or who received short-term (up to 14 days) direct-acting antiviral treatment for hepatitis C infection in a selected Tibotec-sponsored Phase I study.
    Otwarte, jednogrupowe, badanie kliniczne fazy III preparatu TMC435
    stosowanego w skojarzeniu z peginterferonem alfa-2a oraz rybawiryną
    w leczeniu pacjentów z zakażeniem wirusem zapalenia wątroby C (HCV)
    genotypu 1, którzy uprzednio należeli do grupy przyjmującej placebo w
    badaniu preparatu TMC435 fazy II/III (kod badania C201, C205, C206,
    C208, C216 lub HPC3007) lub którzy otrzymywali krótkoterminowe (do
    14 dni) bezpośrednie leczenie przeciwwirusowe z powodu zakażenia
    wirusem HCV w wybranych badaniach klinicznych fazy I
    sponsorowanych przez firmę Tibotec.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III, Open-Label, Single Arm Trial of TMC435 in Combination With Peginterferon Alpha-2A and Ribavirin for HCV Genotype-1 Infected Subjects Who Participated in the Placebo Group of a Phase II/III TMC435 Study, or Who Received DAA Treatment in a Tibotec-Sponsored Phase I Study.
    A.4.1Sponsor's protocol code numberTMC435-TiDP16-C213
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01323244
    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 SponsorJanssen R&D Ireland
    B.1.3.4CountryIreland
    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 supportJanssen R&D Ireland
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV - Clinical Registry Group
    B.5.2Functional name of contact pointJanssen Biologics BV
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310715242166
    B.5.5Fax number+310715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameJNJ-38733214-AAA - capsule , hard - 150mg
    D.3.2Product code TMC435 (or R494617)
    D.3.4Pharmaceutical form Capsule, hard
    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 INNsimeprevir
    D.3.9.1CAS number 923604-59-5
    D.3.9.2Current sponsor codeTMC435
    D.3.9.3Other descriptive nameJNJ-38733214-AAA (or R494617)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Virus (HCV) genotype-1 infection
    Wirusowe zapalenie wątroby C, zakażenie wirusem zapalenia wątroby C
    (HCV) genotypu 1
    E.1.1.1Medical condition in easily understood language
    Hepatitis C infection
    Wirusowe zapalenie wątroby C
    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
    The primary objective is to evaluate the antiviral efficacy of TMC435 in
    combination with PegIFNalfa-2a and RBV, with respect to the proportion
    of subjects with SVR12 (1) in the subjects who participated in the
    placebo group of a Phase II/III TMC435 study, and (2) in the subjects
    who participated in a selected Tibotec-sponsored Phase I study
    Celem głównym tego badania jest ocena skuteczności przeciwwirusowej
    preparatu TMC435 stosowanego w skojarzeniu z PegIFNa-2a oraz RBV,
    pod względem odsetka pacjentów z długotrwałą odpowiedzią
    wirusologiczną po 12 tygodniach leczenia (SVR12) (1) u pacjentów,
    którzy należeli do grupy placebo w badaniu klinicznym fazy II/III
    preparatu TMC435 oraz (2) u pacjentów, którzy uczestniczyli w
    wybranych badaniach klinicznych fazy I sponsorowanych przez firmę
    Tibotec.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    1. To evaluate the antiviral efficacy of TMC435 in combination with
    PegIFNalfa-2a and RBV with respect to the proportion of subjects with
    SVR24.
    - To evaluate the antiviral activity to TMC435 in combination with
    PegIFNalfa-2a and RBV at all time points, with focus on Week 4, Week
    12, Week 24, and Week 48.
    - To evaluate the incidence of on-treatment failure.
    - To evaluate the rate of HCV viral breakthrough during treatment.
    - To evaluate the viral relapse rate after treatment.
    - To determine the proportion of subjects who meet the criteria for
    treatment completion at Week 24 in the subgroups of subjects who
    experienced viral relapse or viral breakthrough in a Phase II/III TMC435
    study.
    - To determine the viral NS3/4A sequence of subjects not achieving
    SVR.
    - To evaluate the safety and tolerability of TMC435 in combination with
    PegIFNalfa-2a and RBV.
    1.Ocena skuteczności przeciwwirusowej TMC435 stosowanego w
    skojarzeniu z PegIFNa-2a oraz RBV pod względem odsetka pacjentów z
    SVR24
    - Ocena skuteczności przeciwwirusowej TMC435 stosowanego w
    skojarzeniu z PegIFNa-2a oraz RBV we wszystkich punktach czasowych,
    ze szczególnym uwzględnieniem tygodnia 4, tygodnia 12, tygodnia 24
    oraz tygodnia 48
    - Ocena częstości występowania niepowodzenia wirologicznego podczas
    leczenia
    - Ocena częstości występowania przełomu wiremicznego HCV podczas
    leczenia
    - Ocena częstości występowania nawrotów wiremii po leczeniu
    - Określenie odsetka pacjentów, którzy spełniają kryteria pozwalające na
    zakończenie leczenia w tygodniu 24 w podgrupach pacjentów z
    nawrotem wiremii lub z przełomem wiremicznym w badaniu TMC435
    fazy II/III
    - Określenie sekwencji proteazy NS3/4A wirusa u pacjentów nie
    osiągających trwałej odpowiedzi wirologicznej (SVR)
    Ocena bezpieczeństwa i tolerancji TMC435 stosowanego w skojarzeniu z
    PegIFNa 2a oraz RBV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients who participated in the placebo arm of a TMC435 study who
    did not achieve undetectable HCV RNA levels at end of treatment or who
    relapsed within 1 year after end of treatment OR Patients who received
    short-term direct-acting antiviral therapy in a Tibotec- sponsored study.
    - Liver disease stage documented by liver biopsy is required within 3
    years prior to screening unless contraindicated. Please refer to the
    protocol for the complete list of inclusion criteria
    - Pacjenci, którzy należeli do grupy placebo w badaniu klinicznym
    preparatu TMC435 i nie osiągnęli niewykrywalnego poziomu RNA wirusa
    HCV na końcu leczenia lub u których wystąpił nawrót wiremii w okresie
    do 1 roku po zakończeniu leczenia LUB pacjenci, którzy otrzymywali
    krótkoterminowe, bezpośrednie leczenie przeciwwirusowe w wybranych
    badaniach klinicznych sponsorowanych przez firmę Tibotec.
    - Stadium choroby wątroby potwierdzone wynikiem biopsji wątroby jest
    wymagane w okresie do 3 lat przed przesiewem, o ile biopsja nie jest
    przeciwwskazana.
    Kompletna lista kryteriów włączenia do badania została podana w
    protokole badania.
    E.4Principal exclusion criteria
    - Infection with human immunodeficiency virus.
    - Liver disease not related to hepatitic C infection.
    - Significant laboratory abnormalities or other active diseases.
    - Pregnant or planning to become pregnant.
    - Prematurely stopped medication in previous TMC435 study for
    noncompliance or for safety reasons.
    Please refer to the protocol for the complete list of exclusion criteria
    - Obecność zakażenia ludzkim wirusem niedoboru odporności (HIV).
    - Choroba wątroby niezwiązana z zakażeniem wirusem zapalenia
    wątroby C.
    - Istotne nieprawidłowości w badaniach laboratoryjnych lub obecność
    innych czynnych chorób.
    - Ciąża lub zamiar zajścia w ciążę.
    - Przedwczesne przerwanie przyjmowania leku w ramach poprzedniego
    badania preparatu TMC435 z powodu braku dyscypliny pacjenta lub ze
    względów bezpieczeństwa.
    Kompletna lista kryteriów wykluczenia z badania została podana w
    protokole badania.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of participants with sustained viral response
    Odsetek uczestników badania z trwałą odpowiedzią wirusologiczną
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after planned end of treatment
    12 tygodni po planowanym zakończeniu leczenia
    E.5.2Secondary end point(s)
    - The proportion of participants with sustained viral response - Number
    of participants with HCV RNA level >1000 IU/mL
    - Number of participants with viral breakthrough
    - Number of participants with viral relapse
    - Number of participants with normalized alanine aminotransferase
    levels
    - Number of participants with on-treatment failure
    - Number of participants affected by an adverse event
    - Odsetek uczestników z trwałą odpowiedzią wirusologiczną
    - Liczba uczestników z zawartością RNA HCV >1000 IU/ml
    - Liczba uczestników z przełomem wiremicznym
    - Liczba uczestników z nawrotem wiremii
    - Liczba uczestników ze znormalizowanymi poziomami aminotransferazy
    alaninowej
    - Liczba uczestników z niepowodzeniem podczas leczenia
    - Liczba uczestników, u których wystąpiło zdarzenie niepożądane
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 24 weeks after planned end of treatment
    - Week 4
    - Through Week 48
    - Through Week 48
    - Through Week 48
    - Through Week 48
    - Through Week 48
    - 24 tygodnie po planowanym zakończeniu leczenia
    - Tydzień 4
    - Do tygodnia 48
    - Do tygodnia 48
    - Do tygodnia 48
    - Do tygodnia 48
    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 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) 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    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
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Denmark
    France
    Germany
    Israel
    Italy
    Mexico
    Netherlands
    New Zealand
    Norway
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Slovakia
    Spain
    Turkey
    Ukraine
    United Kingdom
    United States
    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 subject undergoing the trial
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 318
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 326
    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)
    Not different from the expected normal treatment of that condition.
    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 Decision2012-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-31
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