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    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-000824-12
    Sponsor's Protocol Code Number:5172-068
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-000824-12
    A.3Full title of the trial
    A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, GT5, and GT6 Infection
    Ensayo clínico aleatorizado de fase III para evaluar la eficacia y la seguridad del régimen en combinación de MK 5172/MK 8742 en sujetos que han presentado fracaso con un tratamiento previo con interferón pegilado y ribavirina (P/R) con infección crónica por el VHC GT1, GT4, GT5 y GT6
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MK-5172 in Combination with MK-8742 with and without Ribavirin (RBV) in HCV patients who failed Prior pegylated interferon (peg-IFN) and RBV treatment
    MK 5172 en combinación con MK 8742con y sin rivabirina en sujetos que han presentado fracaso con un tratamiento previo con interferón pegilado y ribavirina (P/R)
    A.4.1Sponsor's protocol code number5172-068
    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 de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@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 5172A
    D.3.2Product code MK 5172A
    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.3.8INN - Proposed INNMK-5172
    D.3.9.2Current sponsor codeMK-5172
    D.3.9.4EV Substance CodeSUB30825
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMK-8742
    D.3.9.2Current sponsor codeMK-8742
    D.3.9.3Other descriptive nameMK-8742
    D.3.9.4EV Substance CodeSUB125792
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Rebetol
    D.2.1.1.2Name of the Marketing Authorisation holderMerck, Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameRebetol
    D.3.4Pharmaceutical form Capsule
    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 INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    D.3.9.3Other descriptive nameRIBAVIRIN
    D.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Hepatitis C
    E.1.1.1Medical condition in easily understood language
    A viral infection affecting the liver
    Infección viral que afecta al hígado
    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
    1. To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as HCV RNA <LLOQ (either TD[u] or TND) 12 weeks after the end of all study therapy.
    2. To evaluate the safety and tolerability of MK-5172 in combination with MK-8742.
    1. Evaluar la eficacia de MK 5172 en combinación con MK 8742 mediante la proporción de sujetos que logren una RVS12 (respuesta virológica sostenida 12 semanas después del final de todo el tratamiento del estudio), que se define como una concentración de ARN del VHC < LIC (objetivo detectable no cuantificable [OD(nc)] u objetivo no detectable [OND]) 12 semanas después del final de todo el tratamiento del estudio.
    2. Evaluar la seguridad y la tolerabilidad de MK 5172 en combinación con MK 8742.
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of MK-5172 in combination with MK-8742 (+/-RBV) as assessed by the proportion of subjects achieving SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy), defined as HCV RNA <LLOQ (either TD[u] or TND) 24 weeks after the end of all study therapy.
    1. Evaluar la eficacia de MK 5172 en combinación con MK 8742 (+/ RBV) mediante la proporción de sujetos que logren una RVS24 (respuesta virológica sostenida 24 semanas después del final de todo el tratamiento del estudio), que se define como una concentración de ARN del VHC < LIC (OD(nc) u OND) 24 semanas después del final de todo el tratamiento del estudio.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The Sponsor will conduct Future Biomedical Research on specimens routinely and
    specifically collected during this clinical trial. This research may include genetic analyses (DNA), gene expression profiling (RNA), proteomics, metabolomics (serum, plasma) and/or the measurement of other analytes.
    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.
    El promotor llevará a cabo futuras investigaciones biomédicas con las muestras obtenidas de forma sistemática y específica durante este estudio clínico. Dichas investigaciones podrán incluir análisis genéticos (ADN), determinaciones de perfiles de expresión génica (ARN), proteómica, metabolómica (suero, plasma) y mediciones de otros analitos. Estas investigaciones tendrán por objeto el análisis de biomarcadores para abordar aspectos nuevos que no se describen en otras partes del protocolo (como parte del estudio principal) y solo se llevarán a cabo en muestras de los sujetos que hayan otorgado el consentimiento correspondiente. El objetivo de la obtención de muestras para futuras investigaciones biomédicas consiste en estudiar e identificar biomarcadores que proporcionen información a los científicos sobre las enfermedades y sus tratamientos
    E.3Principal inclusion criteria
    1. Be > or = to 18 years of age on day of signing informed consent.
    2. HCV RNA (> or = to 10,000 IU/mL in peripheral blood) at the time of screening.
    3. Have documented chronic HCV GT1, GT4, GT5 or GT6
    4. Have had a liver biopsy, Fibroscan, or Fibrotest to check for cirrhosis
    5. Have a previous HCV treatment status that is of non-response, partial response or treatment relapse
    6. For HIV-1 co-infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit
    7. For HIV-1 co-infection CD4+ T-cell count > 200 cells/mm3 at screening
    1.Tener mayor o igual a una edad mínima de 18 años el día de la firma del consentimiento informado.
    2.Tener una concentración de ARN del VHC ( mayor o igual a10.000 UI/ml en sangre periférica) en el momento de selección
    3.Tener una infección crónica documentada por el VHC GT1, GT4, GT5 o GT6
    4.Disponer de una evaluación del estadio de la hepatopatía: Biopsia hepática, Fibroscan o Fibrotest para evaluar la presencia de cirrosis
    5.Presentar un estado previo de tratamiento del VHC que se corresponda con una de las circunstancias siguientes: Respuesta nula, Respuesta parcial al tratamiento previo o Recidiva tras el tratamiento previo
    6.En sujetos coinfectados por el VIH, presentar infección por el VIH 1, documentada con una prueba autorizada de detección rápida del VIH o un kit de inmunoanálisis de quimioluminiscencia (E/CIA).
    7.En los sujetos coinfectados por el VIH, recuento de linfocitos T CD4+ > 200 células/mm3 en la selección
    E.4Principal exclusion criteria
    1. Has evidence of decompensated liver disease
    2. Is coinfected with hepatitis B virus (e.g. HBsAg positive).
    3. Has previous direct acting antiviral treatment.
    4. Has signs of hepatocellular carcinoma or history of malignancy
    5. Is taking or plans to take (a) any HIV therapy, or other medication
    not allowed for the study
    6. Have an exclusionary laboratory value
    1.Presenten indicios de hepatopatía descompensada
    2.Presenten una infección simultánea por el virus de la hepatitis B (por ejemplo, BsAg positivo).
    3.Hayan recibido tratamiento antiviral previo de acción directa.
    4.Tengan antecedentes de neoplasias malignas o signos de carcinoma hepatocelular
    5.Estén tomando o tengan previsto tomar (a) cualquier tratamiento contra el VIH o (b) otros medicamentos prohibidos en el estudio.
    6.Tengas valores de laboratorio que sean excluyentes
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects achieving SVR12
    Proporción de sujetos con RVS12 (respuesta virológica sostenida 12 semanas)
    E.5.1.1Timepoint(s) of evaluation of this end point
    FU12 wk
    Seguimiento en la semana 12
    E.5.2Secondary end point(s)
    The proportion of subjects achieving SVR24
    Proporción de sujetos con RVS24 (respuesta virológica sostenida 24 semanas)
    E.5.2.1Timepoint(s) of evaluation of this end point
    FU24 wk
    Seguimiento en la semana 24
    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 Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Canada
    Denmark
    France
    Netherlands
    New Zealand
    Australia
    Finland
    Korea, Republic of
    Malaysia
    Puerto Rico
    Spain
    Israel
    Poland
    Taiwan
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 100
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 400
    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
    Ninguno
    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 Decision2014-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
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