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    Summary
    EudraCT Number:2016-001159-37
    Sponsor's Protocol Code Number:MK-5172-096
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-06-16
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-001159-37
    A.3Full title of the trial
    A Multi-Site, Open-Label, Partially-Randomized Trial of the Efficacy and Safety of Fixed Dose Elbasvir/Grazoprevir (EBR/GZR) Based Regimens in French Subjects with Chronic Hepatitis C Virus (HCV) Genotype 4 Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy/Safety of MK5172 in TN/TE GT4 HCV French Patients
    A.3.2Name or abbreviated title of the trial where available
    Efficacy/Safety of MK5172 in TN/TE GT4 HCV French Patients
    A.4.1Sponsor's protocol code numberMK-5172-096
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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., a subsidiary of Merck & Co., Inc.
    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, New Jersey
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267305-0848
    B.5.6E-mailrohit.talwani@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 namefixed dose combination (FDC) of elbasvir (50 mg) and grazoprevir (100 mg)
    D.3.2Product code MK-5172A (MK-8742/MK-5172)
    D.3.4Pharmaceutical form Film-coated 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 INNElbasvir
    D.3.9.2Current sponsor codeMK-8742
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGrazoprevir
    D.3.9.2Current sponsor codeMK-5172
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Infection
    E.1.1.1Medical condition in easily understood language
    Hepatitis 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076826
    E.1.2Term Chronic hepatitis C genotype 4
    E.1.2System Organ Class 100000004862
    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 each treatment arm of EBR/GZR as assessed by the proportion of subjects achieving SVR12 [sustained virologic response defined as HCV RNA <Lower Limit of Quantitation (LLOQ) 12 weeks after the end of all study therapy].
    (2) To evaluate the safety and tolerability of EBR/GZR.
    E.2.2Secondary objectives of the trial
    (1) To evaluate the efficacy of each treatment arm of EBR/GZR as assessed by the proportion of the treatment naïve F0-F2 subjects achieving SVR12.
    (2) To evaluate the efficacy of each treatment arm of EBR/GZR as assessed by the proportion of subjects achieving SVR24 (sustained virologic response defined as HCV RNA < LLOQ 24 weeks after the end of all study therapy).
    (3) To evaluate resistance-associated variants (RAVs) to EBR or GZR, including the association of baseline RAVs with treatment outcomes and the emergence of RAVs in subjects who fail to achieve SVR.
    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. be ≥ 18 years of age on day of signing informed consent
    2. be a current resident of France
    3. have HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
    4. have documented chronic HCV GT4 (with no evidence of non -typeable or mixed genotype) infection and meet the definition below:
    a. positive for anti-HCV antibody, HCV RNA, or HCV GT4 at least 6 months before screening, or
    b. positive for anti-HCV antibody or HCV RNA at screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis)
    5. have one of the below liver staging assessments as follows:
    a. Liver biopsy performed within 24 months of Day 1 of this study (if subject has cirrhosis, there is no time restriction on biopsy)
    b. FibroScan® performed within 12 months of Day 1 of this study with interpretable result in kilopascals (kPa) as follows
    •Fibrosis score of F0-F2 = <8.0 kPa
    •Fibrosis score of F3 = 8.0 – 12.5 kPa
    •Cirrhosis (F4) = >12.5 kPa
    c. For cirrhotic (F4) subjects only: A FibroTest® (FibroSure®)* performed during Screening with a score of >0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) of >2.
    6. have a prior treatment history of either of the following:
    a. HCV treatment-naïve (TN)
    b. HCV treatment-experienced (TE) with IFN +/- RBV +/- SOF:
    •On-treatment Failure
    •Relapser
    •Other/intolerant
    7. meet one of the following categories:
    a. the subject is a male.
    b. the subject is a female who is not of reproductive potential
    c. the subject is a female who is of reproductive potential and agrees to avoid becoming pregnant from Day 1 through 14 days after the last dose of study drug or longer if dictated by local regulations by complying with one of the following: (1) practice abstinence† from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity.
    8. understands the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
    9. provides written informed consent for the trial. The subject may also provide consent for future biomedical research (FBR). However, the subject may participate in the main trial without participating in FBR.

    For HIV co-infected subjects, these additional criteria must also be met:

    10. have HIV-1 infection documented at any time prior to study entry (Day 1) by any licensed rapid HIV test or HIV enzyme or chemiluminescense immunoassay (E/CIA) test kit and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
    11. meet one of the following criteria:
    a. If not currently on antiretroviral therapy (ART) and has no plan to initiate ART treatment while participating in this study:
    i. Subjects not on ART must have CD4+ T-cell count > 500 cells/mm3 at screening.
    b. have well controlled HIV on ART, defined as:
    i. must have achieved and maintained virologic suppression (defined as confirmed HIV RNA level below the LLOQ of available assay) on HIV ART at least 8 weeks prior to study entry (Day 1).
    a) ART regimen must contain only the following antiretroviral medications: tenofovir, abacavir, lamivudine, emtricitabine, raltegravir, dolutegravir, and rilpivirine.
    b) Dose modifications or changes in drugs during the 4 weeks prior to study entry (Day 1) are not permitted.
    ii. have HIV RNA < LLOQ at screening
    iii. subjects on ART must have a CD4+ T-cell count > 200 cells/mm3 at screening.

    E.4Principal exclusion criteria
    1. is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
    2. had prior treatment (defined as 1 dose or more) with DAA therapy not listed in the protocol.
    3. has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of active advanced liver disease.
    4. is classified as Child-Pugh B or C or has a Child Pugh-Turcotte score (CPT)> 6
    5. has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
    6. is co-infected with hepatitis B virus (e.g., HBsAg positive).
    7. is under evaluation for active or suspected malignancy, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
    8. is taking or plans to take any of the prohibited medications listed in the protocol.
    9. is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study.
    10. has clinically-relevant drug or alcohol abuse within 12 months of screening, in the opinion of the investigator that would compromise the patient’s ability to participate in the trial.
    11. is a female and is pregnant or breastfeeding, or expecting to conceive or donate eggs from Day 1 through 14 days after the last dose of study drug or longer if dictated by local regulations, OR a male subject who is expecting to donate sperm from Day 1 through 14 days after the last dose of study drug or longer if dictated by local regulations.
    12. has any clinically-significant illness (other than HCV) or any other major medical disorder that in the opinion of the investigator may interfere with subject treatment, assessment or compliance with the protocol or any medical/surgical conditions that may result in a need for hospitalization during the period of the study; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
    13. has exclusionary laboratory values at the screening visit as listed in the protocol
    14. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects achieving SVR12 (Sustained Virologic Response
    12 weeks after the end of all study therapy).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after the last dose of study medication
    E.5.2Secondary end point(s)
    Proportion of subjects achieving SVR24 (Sustained Virologic Response
    24 weeks after the end of all study therapy).
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks after the end of all study therapy
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 Yes
    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.8.2.4Number of treatment arms in the trial2
    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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    No plans for retreatment
    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 Decision2017-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-15
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