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    Summary
    EudraCT Number:2016-000620-26
    Sponsor's Protocol Code Number:MK-3682B-034
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-07-20
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-000620-26
    A.3Full title of the trial
    A Phase II/III, Open-label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-3682B (MK-3682 + Grazoprevir + MK-8408 Fixed Dose Combination) in Subjects with Chronic Hepatitis C Virus GT5 or GT6 Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MK-3682B Fixed Dose Combination (FDC) in Subjects with Chronic Hepatitis C Virus (HCV) Infection
    A.3.2Name or abbreviated title of the trial where available
    MK-3682B Fixed Dose Combination in Subjects with Chronic Hepatitis C Virus GT5 or GT6 Infection
    A.4.1Sponsor's protocol code numberMK-3682B-034
    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 Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267305-0856
    B.5.5Fax number+1267305-6537
    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 INNMK-3682
    D.3.9.2Current sponsor codeMK-3682
    D.3.9.3Other descriptive nameMK-3682
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number225
    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 nameGZR
    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 INNMK-8408
    D.3.9.2Current sponsor codeMK-8408
    D.3.9.3Other descriptive nameMK-8408
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Chronic Hepatitis C Infected Patient
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis C Infected Patient
    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 LLT
    E.1.2Classification code 10019183
    E.1.2Term HCV
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    MK-3682B (MK-3682 [225 mg] + GZR [50 mg] + MK-8408 [30 mg]) administered as two fixed-dose combination (FDC) tablets given once daily; Objectives will be evaluated separately for each HCV Genotype (GT)
    1. To evaluate the efficacy of MK-3682B following 12 weeks of treatment as assessed by the proportion of subjects achieving SVR12 (defined as HCV 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
    E.2.2Secondary objectives of the trial
    Objectives will be evaluated for each HCV GT
    1. To evaluate the efficacy of MK-3682B following 8 weeks of treatment as assessed by the proportion of subjects achieving SVR12 (HCV RNA <LLOQ 12 weeks after the end of study therapy)
    2. To evaluate the efficacy of 12 or 8 weeks of treatment with MK-3682B, respectively, as assessed by the proportion of subjects achieving SVR24 (HCV RNA <LLOQ 24 weeks after the end of study therapy)
    3. To evaluate the efficacy of 12 or 8 weeks of treatment with MK-3682B, respectively, as assessed by the proportion of subjects experiencing virologic failure (either on-treatment failure or relapse post-treatment) at FW12 among subjects who do not discontinue the study for non-treatment-related reasons
    4. To evaluate the effect of baseline resistance-associated polymorphisms in NS3, NS5A, and/or NS5B on the efficacy of 12 or 8 weeks of treatment with MK-3682B, respectively, as assessed by the proportion of subjects with baseline RAPs achieving SVR12
    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 theprotocol (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 >or=18 years of age and >or= age of consent per local regulations on day of signing informed consent
    2. HCV RNA (>or= 10,000 IU/mL in peripheral blood) at the time of screening
    3. have documented chronic HCV GT5 or GT6 (with no evidence of non-typeable or mixed GT) infection and meet the definition below:
    - Positive for anti-HCV antibody, HCV RNA, or HCV GT5 or GT6 at least 6 months before Day 1, or
    - 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
    4. be otherwise healthy as determined by the medical history, physical examination, ECG, and clinical laboratory measurements performed at the time of screening
    5. have liver disease staging assessment as follows:
    Absence of cirrhosis is defined as any one of the following:
    - Liver biopsy performed within 24 months of Day 1 of this study showing absence of cirrhosis
    - Fibroscan performed within 12 months of Day 1 of this study with a result of <or=12.5 kPa
    - A Fibrosure® (Fibrotest®) score of <or=0.48 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) of <or=1 during Screening
    Compensated cirrhosis is defined as any one of the following:
    - A liver biopsy performed prior to Day 1 of this study showing cirrhosis (F4)
    - Fibroscan performed within 12 calendar months of Day 1 of this study with a result >12.5 kPa
    - A FibroSure® (Fibrotest®) performed during Screening with a score of >0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) of >2. APRI formula: AST÷lab upper limit of normal (ULN) for AST × 100÷ (platelet count÷100) (APRI calculation to be provided by the central laboratory)
    NOTE: In the absence of a definitive diagnosis of presence or absence of cirrhosis by the above criteria, a liver biopsy or Fibroscan is required. Liver biopsy results supersede the results obtained by Fibroscan® or Fibrosure®
    6. be HCV treatment naïve (defined as no prior exposure to any interferon, RBV, or other approved or experimental HCV-specific direct-acting antiviral agent) OR prior virologic failure after treatment with an interferon-containing regimen (comprised of interferon or pegylated interferon, with or without ribavirin) only. Subjects who were intolerant to an interferon-containing regimen will be allowed to enroll. Subjects may not have previously received treatment with HCV direct-acting antiviral agents
    7. meet one of the following criteria:
    a. The subject is a male who is not of reproductive potential, defined as a male who has azoospermia (whether due to having had a vasectomy or due to an underlying medical condition)
    b. The subject is a female who is not of reproductive potential, defined as a female who either: (1) is postmenopausal (defined as at least 12 months with no menses in women >or=45 years of age); (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing
    c. The subject is a female or a male who is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner beginning at least 2 weeks prior to administration of the initial dose of study drug through 14 days after taking 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 their partner use) acceptable contraception during heterosexual activity. Acceptable methods of contraception are‡:
    Single method (one of the following is acceptable):
    - intrauterine device (IUD)
    - vasectomy of a female subject’s male partner
    - contraceptive rod implanted into the skin
    Combination method (requires use of two of the following):
    - diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)
    - cervical cap with spermicide (nulliparous women only)
    - contraceptive sponge (nulliparous women only)
    - male condom or female condom (cannot be used together)
    - hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection
    †Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject’s preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ERCs/IRBs. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception
    ‡If a contraceptive method listed above is restricted by local regulations/guidelines, then it does not qualify as an acceptable method of contraception for subjects participating at sites in this country/region.
    Refer to protocol for complete list.
    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. 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
    3. For cirrhotics:
    a. subjects that are Child-Pugh Class B or C, or who have a Pugh-Turcotte score >6, must be excluded
    NOTE To calculate the Child-Pugh score, refer to the following website: http://www.mdcalc.com/child-pugh-score-for-cirrhosis-mortality
    4. is coinfected with hepatitis B virus (eg. HBsAg positive)
    5. For subjects with HIV, has a history of opportunistic infection in the preceding 6 months prior to screening. A list of these events may be found in Appendix B of the following document: http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm
    6. has a history of malignancy <or=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
    7. has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma or is under evaluation for HCC
    NOTE If liver imaging within 6 months prior to Day 1 is not available, imaging is required during screening
    8. 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. 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, in the opinion of the investigator, clinically-relevant drug or alcohol abuse within 12 months of screening
    11. is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from at least 2 weeks prior to Day 1 through at least 14 days after the last dose of study drug, or longer if dictated by local regulations, OR is a male subject who is expecting to donate sperm or planning to impregnate female partner(s) from at least 2 weeks prior to Day 1 through 14 days after the last dose of study drug, or longer if dictated by local regulations
    NOTE After randomization, female subjects should avoid conceiving or donating eggs and male subjects should avoid impregnating a partner or donating sperm for at least 14 days after taking the last dose of study drug
    12. 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 trial
    c. Subject with a history of gastric surgery (eg. stapling, bypass) or subject with a history of malabsorption disorders (eg. celiac sprue disease)
    d. Any clinically significant cardiac abnormalities/dysfunction that may interfere with subject treatment, assessment, or compliance with the protocol, including but not limited to: unstable angina, unstable congestive heart failure, significant arrhythmia; subjects 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 subject treatment, assessment, compliance with the protocol, or confound the results of the study or pose additional risk in administering the study drug to the subject
    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 period of the study
    h. Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, TNF antagonists, or other immunosuppressant drugs during the course of the trial
    i. Life-threatening 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
    NOTE Subjects with history of acute non-HCV-related hepatitis, which resolved >6 months before study entry, can be enrolled
    Refer to protocol for complete list
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects achieving SVR12
    E.5.1.1Timepoint(s) of evaluation of this end point
    SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy). The subject has HCV RNA <LLOQ 12 weeks after the end of all study therapy
    E.5.2Secondary end point(s)
    Proportion of subjects achieving SVR24
    Proportion of subjects experiencing virologic failure at Follow-up Week 12 among subjects who do not discontinue study for non-treatment-related reasons
    E.5.2.1Timepoint(s) of evaluation of this end point
    SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy). The subject has HCV RNA <LLOQ 24 weeks after the end of all study therapy
    Virologic failure rate among subjects who do not discontinue the study for non-treatment-related reasons at FW12
    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 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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 EEA5
    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
    Belgium
    Canada
    France
    Hong Kong
    South Africa
    Thailand
    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 months2
    E.8.9.1In the Member State concerned days1
    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 days6
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 160
    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)
    There is no planned treatment for subjects after his/her participation has ended in the study. However, a long term follow up is planned to assess the persistence of resistance-associated polymorphisms over time.
    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 Decision2016-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-08-24
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