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    Summary
    EudraCT Number:2011-000416-25
    Sponsor's Protocol Code Number:TMC435-TiDP16-C213
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-17
    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 ConcernedNetherlands - Competent Authority
    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.
    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.1.3.4CountryBelgium
    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 supportTibotec Pharmaceuticals
    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
    E.1.1.1Medical condition in easily understood language
    Hepatitis C infection
    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 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 PegIFNalpha-2a and RBV, with respect to the proportion of subjects with SVR24 (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.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To evaluate the antiviral efficacy of TMC435 in combination with PegIFNalpha-2a and RBV with respect to the proportion of subjects with SVR12.
    - To evaluate the on-treatment virologic response to TMC435 in combination with PegIFNalpha-2a and RBV at all time points, with focus on Week 4, Week 12, Week 24, and Week 48.
    - To evaluate the incidence of virologic failure 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 with virologic failure.
    - To evaluate the safety and tolerability of TMC435 in combination with PegIFNalpha-2a and RBV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject was previously randomized to the placebo group of a Phase II/III TMC435 study and did not achieve undetectable HCV RNA levels at the end of treatment or relapsed (confirmed detectable HCV RNA) within 1 year after end of treatment.
    OR
    Subject received short-term (up to 14 days) DAA treatment for HCV infection in a selected Tibotec-sponsored Phase I study on genotype 1;
    - Subject must have completed the last study-related assessment in the previous study.

    Please refer to the protocol for the complete list of inclusion criteria.
    E.4Principal exclusion criteria
    - Subject shows evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy);
    - Subject has co-infection with nongenotype 1 HCV. Since all subjects have previously participated in a study evaluating subjects with genotype 1 HCV infection, this screening test is at the discretion of the investigator, to rule out nongenotype 1 HCV infection in case of clinical signs of acute hepatitis infection and suspicion of possible re-infection;
    - Subject has co-infection with HIV type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at Screening);
    - Subject has any of the following laboratory abnormalities at screening: platelet count ≤ 90,000/mm3; absolute neutrophil count < 1500 cells/mm3 (blacks: < 1200 cells/mm3; hemoglobin < 12 g/dL for women and < 13 g/dL for men; creatinine >1.5 mg/dL; alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 10 x ULN; total serum bilirubin > 1.5 x ULN. Note: Retesting of an abnormal laboratory or urinalysis result that leads to exclusion will be allowed once using an unscheduled visit during the screening period to assess eligibility;
    - Subject received any DAA HCV therapy, other than having received short-term (up to 14 days) DAA in a selected Tibotec-sponsored Phase I study;
    - Subject prematurely stopped medication in the previous TMC435 study for noncompliance;
    - Subject prematurely stopped medication in the previous TMC435 study for safety reasons, and it would therefore be unsafe to repeat treatment at investigator’s discretion.

    Please refer to the protocol for the complete list of exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is the proportion of subjects with SVR24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be considered a success if a subject achieves undetectable HCV RNA at EOT and 24 weeks after planned EOT (regardless of treatment completion status)
    E.5.2Secondary end point(s)
    Secondary efficacy parameters include the proportion of subjects:
    1 - with SVR12;
    2 - with undetectable HCV RNA (< 25 IU/mL undetectable) and/or HCV RNA levels < 25 IU/mL at all time points during treatment and follow-up, with focus on Week 4, Week 12, Week 24, Week 36, and Week 48;
    3 - with HCV RNA >1000IU/mL at Week 4 or viral breakthrough, defined as a confirmed increase of > 1 log10 IU/mL in HCV RNA level from the lowest level reached;
    4 - with on-treatment virologic failure, i.e., subject discontinued all study medication because he/she met a virologic stopping rule requiring to stop all treatment;
    5 - with viral relapse, defined as undetectable HCV RNA (< 25 IU/mL undetectable) at the end of treatment and confirmed detectable HCV RNA during follow-up or detectable HCV RNA at SVR assessments;
    6 - with normalized ALT levels at the end of treatment and at SVR assessment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - 12 weeks after the end of treatment;
    2 - at all time points during treatment and follow-up, with focus on Week 4, Week 12, Week 24, Week 36, and Week 48;
    3 - at week 4;
    4 - no timepoint,
    5 - at the end of treatment (undetectable HCV RNA) and during follow-up or at SVR assessment (detectable HCV RNA);
    6 - at the end of treatment and at SVR assessment.
    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 concerned2
    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
    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 years3
    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 years3
    E.8.9.2In all countries concerned by the trial months8
    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: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state15
    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 Decision2011-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
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