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    Summary
    EudraCT Number:2017-001463-21
    Sponsor's Protocol Code Number:MK-3682B-037
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-06-02
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-001463-21
    A.3Full title of the trial
    A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of the Combination Regimen of MK-3682B (Grazoprevir/Ruzasvir/Uprifosbuvir) in Participants with Chronic Hepatitis C Virus Genotype 3 Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MK-3682B in Hepatitis C Virus (HCV) Genotype 3 (GT3) participants
    A.3.2Name or abbreviated title of the trial where available
    MK-3682B in Hepatitis C Virus (HCV) Genotype 3 (GT3) participants
    A.4.1Sponsor's protocol code numberMK-3682B-037
    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 organisation
    B.5.2Functional name of contact point
    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-3682B
    D.3.2Product code MK-3682B
    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 INNGRAZOPREVIR
    D.3.9.2Current sponsor codeMK-5172
    D.3.9.3Other descriptive nameGRAZOPREVIR
    D.3.9.4EV Substance CodeSUB174126
    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 INNRUZASVIR
    D.3.9.2Current sponsor codeMK-8408
    D.3.9.4EV Substance CodeSUB180925
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUprifosbuvir
    D.3.9.2Current sponsor codeMK-3682
    D.3.9.3Other descriptive nameMK-3682
    D.3.9.4EV Substance CodeSUB168240
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number225
    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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of hepatitis C virus (HCV) infection
    E.1.1.1Medical condition in easily understood language
    Treatment of chronic hepatitis C virus (HCV) 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 LLT
    E.1.2Classification code 10019752
    E.1.2Term Hepatitis C virus (HCV)
    E.1.2System Organ Class 100000074171
    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-3682B as assessed by the proportion of participants in the immediate treatment group (ITG) achieving sustained virologic response (SVR) at 12 weeks post-treatment (SVR12) (defined as HCV ribonucleic acid [RNA] <lower limit of quantification [LLOQ] 12 weeks after the end of all study therapy).
    2. To evaluate the safety and tolerability of MK-3682B in the ITG relative to the placebo treatment in the deferred treatment group (DTG) during the double-blind treatment period plus 14 days.
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of MK-3682B as assessed by the proportion of participants in the ITG achieving SVR at 24 weeks post-treatment (SVR24) (defined as HCV RNA <LLOQ 24 weeks after the end of all study therapy).
    2. To evaluate the efficacy of MK-3682B as assessed by the proportion of participants in the ITG experiencing virologic failure (either on-treatment failure or relapse post-treatment) through Follow-up Week (FW) 12 among participants who do not discontinue the study for non-treatment-related (eg, administrative) reasons.
    3. To evaluate the effect of baseline resistance-associated substitutions (RASs) in nonstructural protein 3 (NS3), NS5A, and/or NS5B on the efficacy of MK-3682B, as assessed by the proportion of participants with baseline RASs achieving SVR12, within the ITG and the active treatment period in the DTG.
    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 and plasma) 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. The participant has HCV RNA (≥10,000 IU/mL in peripheral blood) at the time of screening
    2. The participant has documented chronic HCV GT3-infection (with no evidence of nontypeable or mixed GT) as follows:
    a) positive for anti-HCV antibody, HCV RNA, or HCV GT3 at least 6 months before Day 1, or
    b) positive for anti-HCV antibody or HCV RNA with a liver biopsy consistent with chronic HCV infection (such as the presence of fibrosis) before Day 1
    3. The participant has liver disease staging assessment as follows:
    a) Absence of cirrhosis (F0 to F3) defined as any one of the following:
    i. a liver biopsy performed within 24 months of Day 1 showing absence of cirrhosis, or
    ii. FibroScan® performed within 12 months of Day 1 with a result ≤12.5 kPa,or
    iii. FibroSure® (FibroTest®) performed during Screening with a score of ≤0.48 and an aspartate aminotransferase to platelet ratio index (APRI) ≤1
    b) Compensated Cirrhosis (F4) defined as any one of the following:
    i. a liver biopsy performed prior to Day 1 showing cirrhosis, or
    ii. FibroScan® performed within 12 months of Day 1 with a result >12.5 kPa, or
    iii. Fibroure® (FibroTest®) performed during Screening with a score of >0.75 and an APRI >2
    4. The participant has an HCV treatment status that is 1 of the following:
    a) HCV TN (defined as no prior exposure to any IFN-containing regimen, RBV, or other approved or experimental HCV-specific DAA agent)
    b) HCV TE (defined as prior virologic failure after treatment with an IFN-containing regimen, with or without RBV, or intolerance to an IFN-containing regimen). Participants cannot have previously received treatment with HCV-specific DAA agents
    5. The participant is male or female ≥18 years of age on day of signing informed consent
    6. For female participants:
    - A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies :
    a) Not a woman of childbearing potential (WOCBP)
    OR
    b) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 14 days after the last dose of study treatment
    7. The participant provides written informed consent for the study
    8. The participant has HIV infection documented at any time prior to screening by any licensed rapid HIV test or HIV enzyme or chemiluminescence 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 p24 antigen, or plasma HIV RNA VL
    9. The participant meets 1 of the following criteria:
    a) not currently on ART and has no plans to initiate ART while participating in this study, must have CD4+ T-cell count >500 cells/mm3 at time of screening, or
    b) must have well-controlled HIV on ART, defined as all the following:
    i. CD4+T-cell count >200 cells/mm3 at time of screening
    ii. achieved and maintained virologic suppression (defined as confirmed HIV RNA level <LLOQ of available assay) for at least 8 weeks prior to screening, and
    iii. on a stable regimen (without changes in drugs or dose modification) for at least 4 weeks prior to study entry (Day 1)
    The combination ART regimen must not contain any antiretroviral medications other than: abacavir, dolutegravir, emtricitabine, lamivudine, raltegravir, rilpivirine, or tenofovir (disoproxil fumarate or alafenamide).
    E.4Principal exclusion criteria
    1. The participant 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 advanced liver disease
    2. The participant is cirrhotic AND has a Child-Turcotte-Pugh score >6, corresponding to a Child Class B or C
    3. The participant has cirrhosis AND liver imaging within 6 months of Day 1 showing evidence of HCC or is under evaluation for HCC
    4. The participant is coinfected with HIV AND has a history of opportunistic infection in the preceding 6 months prior to screening
    5. The participant has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy
    6. A WOCBP is expecting to conceive or donate eggs from Day 1 through at least 14 days after the last dose of study treatment or longer if dictated by local regulations
    7. The participant has any of the following conditions:
    a. organ transplants (including hematopoietic stem cell transplants) other than cornea and hair
    b. poor venous access that precludes routine peripheral blood sampling required for this study
    c. history of gastric surgery (eg, stapling, bypass) or malabsorption disorders (eg, celiac sprue disease)
    d. any clinically significant cardiac abnormalities/dysfunction that may interfere with participant treatment, assessment, or compliance with the protocol, including but not limited to: unstable angina, unstable congestive heart failure, unstable arrhythmia; participants currently under evaluation for a potentially clinically significant cardiac abnormality/dysfunction are also excluded
    e. any major medical condition, clinically significant illness (other than HCV), pre-study laboratory or ECG abnormality, or history of any illness, which, in the opinion of the investigator, might interfere with participant treatment, assessment, compliance with the protocol, or confound the results of the study or pose additional risk in administering the study drug to the participant
    f. history of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures
    g. medical /surgical conditions that may result in a need for hospitalization during the study duration
    h. any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor antagonists, or other immunosuppressant drugs through FW24
    i. life-threatening serious adverse event (SAE) during the screening period
    j. evidence of history of chronic hepatitis not caused by HCV, including but not limited to, drug-induced hepatitis, hemochromatosis, Wilson’s disease, α1-antitrypsin deficiency, alcoholic liver disease, and autoimmune hepatitis
    8. The participant is taking or plans to take any of the prohibited medications listed in the protocol or is taking herbal supplements, including but not limited to St. John’s Wort (Hypericum perforatum), from 2 weeks prior to Day 1 through 2 weeks after the study treatment period
    9. The participant 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 articipating in another such study through 24 weeks after the study treatment period (FW24)
    10. The participant is hepatitis B surface antigen (HBsAg) positive at screening
    11. The participant has exclusionary laboratory values at the screening visit as listed in the protocol
    12. The participant has significant emotional problems or a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures
    13. The participant has clinically relevant drug or alcohol abuse within 12 months of screening
    14. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this study
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants achieving Sustained virologic response 12 weeks post-treatment (SVR12) in the Immediate treatment group (ITG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Follow-up Week 12
    E.5.2Secondary end point(s)
    1. Proportion of participants achieving SVR24 in the ITG
    2. Proportion of participants experiencing virologic failure through FW12 among all participants who do not discontinue study for non-treatment-related reasons in the ITG
    3. Proportion of participants with baseline RASs achieving SVR12 in the ITG and the active treatment period in the Deferred treatment group (DTG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Follow-up Week 12 and Follow-up Week 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    After a blinded period of 12 weeks, placebo group will receive an open-label treatment with MK3682B
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Australia
    Canada
    Denmark
    France
    Italy
    Lithuania
    Malaysia
    New Zealand
    Poland
    Russian Federation
    Thailand
    United Kingdom
    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 years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    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: 383
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 43
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 426
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation DrugDev TrialNetworks
    G.4.3.4Network Country United States
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-10-06
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