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    Summary
    EudraCT Number:2012-002232-85
    Sponsor's Protocol Code Number:5172-017
    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:2015-07-27
    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 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 Resistance 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 to Evaluate 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
    MK-5172 Protocol 017 Long-term Follow Up Study
    A.4.1Sponsor's protocol code number5172-017
    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 & Dohme, Corp.
    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 Trials 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 code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267305-3729
    B.5.5Fax number+1267305-6520
    B.5.6E-mailbarbara.haber@merck.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
    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 19.0
    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
    1. Evaluate the durability of SVR in subjects who remained HCV RNA<LLoQ throughout the follow-up period of the treatment protocol and did not start any new HCV therapy between the end of the previous protocol and entry in this study
    •All subjects (except subjects PN 052) with HCV RNA<LLoQ will be
    discontinued after the next scheduled visit. PN 052 subjects will remain
    for a duration of 5 years as introduced in AM02. Data collected up to a
    subject's last visit will be assessed for durability. After AM03 approval,
    no additional subjects achieving SVR will enroll
    2. Evaluate the presence of antiviral resistance, NS3/4A, NS5A and/or NS5B, (as appropriate) and determine if there is a reversion to a wildtype pattern within the 3 years (all protocols except PN 052) or 5 years timeframe for PN 052 of this long-term follow-up study
    •Subjects enrolling with quantifiable HCV RNA after having failed therapy will be followed for 3 years or 5 years (PN 052)
    3. Evaluate the long-term safety
    E.2.2Secondary objectives of the trial
    1. To assess liver function using the MELD and/or Child-Pugh scores.

    2. To assess chronic kidney disease (CKD) status by assessing change in eGFR in patients from parent Protocol 052.

    3. To assess complication of CKD by recording new onset diabetes, cryoglobulinemia, cardiovascular disease, and/or neurologic disorders (such as stroke) in patients from parent Protocol 052.

    4. To assess health outcomes by recording the occurrence of variceal bleeding, ascites, spontaneous bacterial peritonitis, encephalopathy, hepatorenal syndrome, hepatocellular carcinoma, liver/kidney transplantation, graft rejection in patient who have undergone liver/kidney transplantation
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck 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
    1. Study subjects who previously participated in a HCV treatment protocol that includes MK-5172 in the treatment regimen.

    2. Subject must enroll (Visit 1) within three months of the last study visit (e.g. follow-up week 24) of their previous protocol in which they received and MK-5172 containing regimen.

    Prior to Amendment 03, if a patient in a treatment protocol received extended follow-up (>or= 1 year) in the original Protocol, they may enroll in this study at the final visits of the previous protocol.

    3. Subject must be ≥ 18 years of age and willing to give written informed consent.

    4. Subjects, who have consented for the trial, may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.

    5. For Amendment 03: Subjects must have received a MK-5172 containing regimen in a prior trial and have been identified as having failed therapy in that study.
    E.4Principal exclusion criteria
    1. In the opinion of the investigator, if a subject is mentally or legally incapacitated at entry, the subject may be excluded.

    2. The subject has received HCV therapy after completion of the protocol defined MK-5172 treatment trial regimen and before or after entry into PN017.

    3. For Amendment 03: Subjects who fail therapy due to re-infection are excluded.

    4. For Amendment 03: subjects who fail therapy and receive treatment with HCV therapy are excluded, except in the case where they were re-treated in a Merck-sponsored protocol.
    E.5 End points
    E.5.1Primary end point(s)
    A primary efficacy endpoint is the durability of long-term 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. Relapse would be
    indicated so long as this was the same genotype of the virus seen in the
    parent protocol (eg. not a new infection or re-infection). Time to relapse
    is defined as the time from last dose of study 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 > or = 1000 IU/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 Yes
    E.6.11Pharmacogenomic No
    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 Yes
    E.8.1.7.1Other trial design description
    Long term follow-up study; no therapy is being provided
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    Poland
    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 months7
    E.8.9.1In the Member State concerned days16
    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 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.1.2.1Number of subjects for this age range: 300
    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 2015-07-27. 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 state70
    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)
    None
    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 Decision2015-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-31
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