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    Summary
    EudraCT Number:2012-002232-85
    Sponsor's Protocol Code Number:MK5172-017
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-10-19
    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 ConcernedItaly - Italian Medicines Agency
    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.
    Studio di follow-up a lungo termine per valutare la durata della risposta virologica e/o i modelli di resistenza virale in soggetti con epatite C cronica e trattati con MK-5172 in una sperimentazione clinica precedente.
    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.
    Studio di follow-up a lungo termine per valutare la durata della risposta virologica e/o i modelli di resistenza virale in soggetti con epatite C cronica e trattati con MK-5172 in una sperimentazione clinica precedente.
    A.4.1Sponsor's protocol code numberMK5172-017
    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., a subsidiary of Merck & Co., Inc.
    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 supportMSD Regional Business Support Center GmbH
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD Italia S.r.l.
    B.5.2Functional name of contact pointDivisione Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Fratelli Cervi, snc - Centro Direzionale Milano Due - Palazzo Borromini
    B.5.3.2Town/ citySegrate (MI)
    B.5.3.3Post code20090
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 21018402
    B.5.5Fax number+39 02 21018629
    B.5.6E-mailgcto.italy@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 nameNA
    D.3.2Product code MK-5172
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeMK-5172
    D.3.9.3Other descriptive nameMK-5172
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    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 Infection (HCV).
    Infezione da virus dell'epatite C (HCV).
    E.1.1.1Medical condition in easily understood language
    Hepatitis C Virus Infection.
    Infezione da virus dell'epatite 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
    To evaluate the persistence of SVR in subjects who remained HCV RNA <25 IU/mL throughout the follow-up period of the treatment protocol.
    Valutare la durata di SVR nei soggetti che mantengono HCV RNA &lt;25 IU/mL per tutto il periodo di follow-up del protocollo di trattamento.
    E.2.2Secondary objectives of the trial
    To evaluate the presence of antiviral resistance to MK-5172 and determine if there is a reversion to a wild-type pattern within the 3 year time-frame of this long-term follow-up study.
    Valutare la presenza di resistenza antivirale a MK-5172 e determinare la presenza di un'inversione al modello ''wild-type'' entro l'arco dei 3 anni del periodo di follow-up a lungo termine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. HCV infected subjects who previously participated in an MK-5172 protocol and received at least one dose of MK-5172. 2. Subject must enroll (Visit 1) within one year of the treatment portion of their previous MK-5172 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.
    1. Soggetti con infezione da HCV che hanno precedentemente partecipato ad un protocollo MK-5172 ed hanno ricevuto almeno una dose di MK-5172. 2. Il soggetto deve essere arruolato (V1) entro 1 anno dal trattamento del precedente protocollo con MK5172. 3. Soggetti di età ≥ 18 anni in grado di dare il consenso informato scritto. 4. Soggetti che hanno dato il consenso alla sperimentazione, possono fornire anche il consenso alla futura ricerca biomedica. Tuttavia, i soggetti possono partecipare allo studio principale senza partecipare alla futura ricerca biomedica.
    E.4Principal exclusion criteria
    In the opinion of the investigator, if a subject is mentally or legally incapacitated at entry, the subject may be excluded.
    Secondo il parere dello sperimentatore, se un soggetto è mentalmente o giuridicamente incapace al momento dell'arruolamento, deve essere escluso.
    E.5 End points
    E.5.1Primary end point(s)
    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 HCV RNA ≥ 25 IU/mL and was previously <25 IU/mL after end of treatment in previous trial (see Section 2.5). Time to relapse is defined as the time from last dose of therapy taken in previous trial until the date where HCV RNA is ≥25 IU/mL. The percentage of subjects who remain HCV RNA <25 IU/mL during the course of this study will also be evaluated. In subjects with HCV RNA ≥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.
    Durata della SVR che sarà valutata in base al tempo per lo sviluppo di recidiva virale. Dopo la fine del trattamento nello studio precedente recidiva virale viene definita come qualsiasi soggetto che ha HCV RNA ≥ 25 UI/mL e in precedenza era <25 IU/mL. Il tempo per sviluppo della recidiva virale è definito come l'intervallo intercorso fra l'ultima dose di farmaco assunto nel corso della precedente sperimentazione e la data in cui il livello di HCV RNA è ≥ 25 UI/mL. Sarà valutata la percentuale di soggetti che mantengono HCV RNA <25 IU/mL nel corso di questo studio. Nei soggetti con HCV RNA ≥ 1000 IU/mL al momento dell'ingresso o durante il periodo di studio, analisi di sequenza HCV saranno eseguite per valutare la presenza di RAVs e la persistenza di RAVs nel corso del tempo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Yearly reporting.
    Relazioni annuali.
    E.5.2Secondary end point(s)
    n.a.
    n.a.
    E.5.2.1Timepoint(s) of evaluation of this end point
    n.a.
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other No
    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.8.2.4Number of treatment arms in the trial1
    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 EEA8
    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
    Canada
    Israel
    Puerto Rico
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months71
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months71
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 2012-10-19. 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 3250
    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)
    n.a.
    n.a.
    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 Decision2013-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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