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    Summary
    EudraCT Number:2012-002232-85
    Sponsor's Protocol Code Number:MK-5172-017
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2013-06-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-002232-85
    A.3Full title of the trial
    A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Risistance Patterns of Subjects with Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long-Term Follow-up Study looking at the Virologic Response (checking a patient's blood to ensure that there is no detectable virus) and/or Viral Resistance (checking that the virus has not changed in anyway which might mean that treatment is no longer effective) of Subjects With Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial
    A.3.2Name or abbreviated title of the trial where available
    A Long Term Follow-up Study of Subjects previously treated with MK5172
    A.4.1Sponsor's protocol code numberMK-5172-017
    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 SponsorMerck Sharp & Dohme Corp.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp and Dohme Corp., a Subsidiary of Merck Sharp and Dohme Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp.
    B.5.2Functional name of contact pointGlobal Clinical Trial Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code0889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number0012673053729
    B.5.5Fax number0012673056520
    B.5.6E-mailbarbara.haber@merck.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 nameMK-5172
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatitis C Virus Infection (HCV)
    E.1.1.1Medical condition in easily understood language
    Hepatitis C Virus 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 20.0
    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
    Adult population:
    1. To evaluate the durability of response in subjects who achieved SVR24 in the prior treatment study and at the time of entry into PN017 were HCV ribonucleic acid (RNA) lower limit quantification (LLoQ) (either target not detected [TND] or target detected, unquantifiable [TD(u)]).
    2. To evaluate the presence of treatment-emergent antiviral resistance to NS3/4A,NS5A and/or NS5B regions, (as applicable) and determine if there is a reversion to wild-type pattern within the 3-year time frame of this long-term follow-up study (05 5 year time frame for subjects from PN052) in subjects with virologic failure in the prior treatment study and with HCV RNA >/= 1000 IU/mL in Protocol 017.
    3. To evaluate long-term safety.

    Paediatric Population:
    1. To evaluate the persistence of treatment-emergent anti-viral resistance to NS3 and NS5A regions within the 3-year time frame of this long-term follow-up study.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    MSD will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and /or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    E.3Principal inclusion criteria
    Inclusion criteria apply to both adult and paediatric populations unless otherwise noted.
    1. Subjects who previously participated in an HCV treatment study and received GZR in the treatment regimen.
    2. Subject must enroll in PN017 (Visit 1) within 3 months of the last study visit (e.g follow-up week 24) of the prior treatment study, in which they received a GZR containing regimen.
    3. Subject is male or female 3 years of age or older on day of signing informed consent/assent.
    4. Subject or subject’s legally acceptable representative provides written informed
    consent (or written informed assent where applicable). Subjects who have consented
    for the study may also provide consent/assent for Future Biomedical Research (FBR).
    However, the subject may participate in PN017 without consenting/assenting for
    FBR.
    5. Starting with AM 03: Adult subject must have received at least 1 dose of a GZR containing regimen in the prior treatment study and identified as having failed therapy in that study.
    6. Paediatric subject must have received at least 1 dose of a GZR-containing regimen and experienced virologic failure with 1 or more associated treatment-emergent RASs at
    FW12 in PN079.
    E.4Principal exclusion criteria
    Exclusion criteria apply to both adult and paediatric populations unless otherwise noted.
    1. Adult subjects: In the opinion of the investigator, if a subject is mentally or legally incapacitated at entry into PN017.
    Paediatric subjects: The subject has significant emotional problems or a clinically
    significant psychiatric disorder that may interfere with participant treatment,
    assessment, or compliance with the protocol.
    2. Subject has received HCV therapy after completion of prior treatment study and before entry into PN017.
    3. Starting with AM 03: subjects who failed therapy due to re-infection, defined as:
    - an HCV RNA sample with a different genotype than the baseline genotype in the
    prior treatment study, or
    - an HCV RNA sample determined to be reinfection by phylogenetic analysis with
    comparison to the baseline sequence in the prior treatment study.
    4. Starting with AM 03: subjects who failed therapy in the prior treatment study and
    received retreatment with HCV therapy.
    E.5 End points
    E.5.1Primary end point(s)
    For Adult Subjects:
    A primary efficacy endpoint is the persistence of SVR which will be evaluated based upon the time to viral relapse. Viral relapse is defined as any subject who has confirmed HCV RNA > or = LLoQ and was previously <LLoQ at end of follow-up in previous trial. Time to relapse is defined as the time from last dose of therapy taken in previous trial until the date where HCV RNA is > or = LLoQ. The percentage of subjects who remain HCV RNA < LLoQ during the course of this study will also be estimated.

    In subjects with HCV RNA ≥1000IU/mL at entry or during the study period, HCV sequence analysis will be performed to evaluate the presence of RAVs and the persistence of RAVs over time.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Yearly reporting.
    E.5.2Secondary end point(s)
    n/a
    E.5.2.1Timepoint(s) of evaluation of this end point
    n/a
    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 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) Yes
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA109
    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
    Canada
    France
    Germany
    Israel
    Italy
    New Zealand
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 298
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 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 2013-06-24. 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 350
    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)
    On study completion, patients will either continue under the care of the Investigator or will be referred back to their GP and treated appropriately as per their clinical judgement.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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