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    Summary
    EudraCT Number:2015-001483-19
    Sponsor's Protocol Code Number:3682-021
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-001483-19
    A.3Full title of the trial
    A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-3682B (MK-5172 + MK-3682 + MK-8408 Fixed Dose Combination (FDC)) in Subjects with Chronic HCV GT1 or GT3 Infection who have failed a Direct Acting Antiviral Regimen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MK-3682B (MK-5172 + MK-3682 + MK-8408 Fixed Dose Combination (FDC)) in HCV GT1 or GT3 DAA Failures
    A.3.2Name or abbreviated title of the trial where available
    MK-3682B (MK-5172 + MK-3682 + MK-8408 Fixed Dose Combination (FDC)) in HCV GT1 or GT3 DAA Failures
    A.4.1Sponsor's protocol code number3682-021
    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 , NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+17325946713
    B.5.6E-mailElizabeth.martin1@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-3682B (Fixed dose combination of MK-5172 (50mg); MK-3682 (225 mg); Mk-8408 (30 mg) per tablet)
    D.3.2Product code MK-3682B
    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 INNMK-5172
    D.3.9.2Current sponsor codeMK-5172
    D.3.9.3Other descriptive nameMK-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 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.3.9.4EV Substance CodeSUB126012
    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 INNMK-3682
    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.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.
    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.3.2Product code Rebetol
    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 nameRebetol
    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 infection
    E.1.1.1Medical condition in easily understood language
    Hep-C
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    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 the combination regimen of MK-5172, MK- 3682 and MK-8408 with or without ribavirin as assessed by the proportion of subjects in each arm achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as HCV RNA <Lower Limit of quantification (LLOQ), either target detected but unquantifiable (TD-u or Target not detected (TND) 12 weeks after the end of all study therapy.
    (2) Objective: To evaluate the safety and tolerability of the combination regimen of MK-5172, MK-3682 and MK-8408 with or without ribavirin to subjects in each arm.
    E.2.2Secondary objectives of the trial
    (1) To evaluate the efficacy of the combination regimen of MK-5172, MK- 3682 and MK-8408 with or without ribavirin as assessed by the proportion of subjects in each arm achieving SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy)
    (2) Objective: To evaluate the efficacy of the combination regimen of MK-5172, MK-3682 and MK-8408 with or without ribavirin as assessed by the proportion of subjects in each arm experiencing virologic failure (either on treatment failure or relapse post-treatment) through FW12 among subjects who do not discontinue the trial for nontreatment- related reasons.
    (3) Objective: To evaluate the effect of baseline resistance-associated substitutions (RASs) in nonstructural protein 3 (NS3), NS5A, and/or NS5B on the efficacy of GZR, RZR, and UPR with or without RBV, as assessed by the proportion of subjects with baseline RAS 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 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
    Enrollment into Part A is complete; therefore, the criteria are applicable to Part B. Refer to MK-3682-021-01 for the Part A inclusion criteria.
    1. Be ≥18 years of age on day of signing informed consent.
    2. Have HCV RNA (≥10,000 IU/mL in peripheral blood) at the time of screening.
    3. Have documented chronic HCV GT1, GT2, GT3, GT4, GT5, or GT6 infection (with no evidence of nontypeable or mixed GT):
    • Positive for anti-HCV antibody, HCV RNA, or HCV GT1, GT2, GT3, GT4, GT5, or GT6 at least 6 months before screening (HCV RNA and HCV GT must be confirmed by screening laboratory results), or
    • Positive for anti-HCV antibody or HCV RNA, at the time of screening, with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of chronic hepatitis C disease, such as the presence of fibrosis), before Day 1.
    4. Have documented VF, defined as having quantifiable HCV RNA at any time after completion of HCV therapy with a DAA regimen, as prescribed by approved dosage and duration or by completion of a clinical trial that was not attributed to re infection. Documentation of prior DAA treatment history must include clinic notes or referral letter documenting regimen administered, approximate dates of treatment, approximate date of VF, and a history of laboratory-confirmed failure.
    •DGT1, GT2, GT4, GT5, or GT6: any prior all-oral DAA regimens
    •DGT3: any prior all-oral DAA regimen or SOF/PR
    5. Have liver disease staging assessment for Absence of cirrhosis or Compensated cirrhosis as defined in the protocol
    6. Meet one of the following criteria:
    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 beginning at least 14 days prior to administration of the initial dose of trial drug through 14 days after the last dose of trial drug or longer if dictated by local regulationsby complying with one of the following: (1) practice abstinence from heterosexual activity OR (2) use (or have their partner use) two forms of acceptable contraception during heterosexual activity. Acceptable methods of contraception are outlined in the protocol
    7. Can be HIV co-infected as documented as requested by protocol
    7. HIV co-infected subjects must either not be on antiretroviral therapy(ART); or have well controlled HIV on ART

    Refer to protocol for a complete list
    E.4Principal exclusion criteria
    Enrollment into Part A is complete; therefore, the criteria are applicable to Part B. Refer to MK-3682-021-01 for the Part A exclusion criteria.
    1. The subject has significant emotional problems or a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
    2. Did not complete their prior DAA therapy due to intolerance to the DAA regimen or who failed the DAA regimen for reasons other than VF.
    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 advanced liver disease.
    4. Is cirrhotic AND has a Child-Turscotte-Pugh score >6, corresponding to a Child Class B or C.
    5. Is hepatitis B surface antigen (HBsAg) positive at screening.
    6. Is co-infected with HIV AND has a history of opportunistic infection in the preceding 6 months prior to screening.
    7. 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.
    8. Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
    9. 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 trial treatment period.
    10. Is currently participating or has participated in a trial with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such trial through 24 weeks after the trial treatment period (FW24). (Subjects participating in MK-5172 Protocol 017 may be enrolled in this trial, MK- 3682 Protocol 021).
    11. Has clinically relevant drug or alcohol abuse within 12 months of screening that may interfere with subject treatment, assessment, or compliance with the protocol.
    12. Is a female subject and is pregnant or breastfeeding, 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 trial drug, or longer if dictated by local regulations. .
    13. Has any of the condition as defined in the protocol
    14. Has an exclusionary laboratory value at the screening visit as as defined in table 5 of the protocol.
    15. 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)
    1) Proportion of subjects achieving SVR12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after the end of treatment
    E.5.2Secondary end point(s)
    1) The proportion of subjects achieving SVR24.
    2) Proportion of subjects experiencing VF through FW12 among subjects who do not discontinue the trial for nontreatment-related reasons.
    3)Proportion of subjects with baseline RASs achieving SVR12
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 24 weeks after the end of treatment
    2 and 3) 12 weeks after the end of Treatment
    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) No
    E.7.4Therapeutic use (Phase IV) No
    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 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.8.2.4Number of treatment arms in the trial5
    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 EEA19
    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
    France
    Germany
    New Zealand
    Spain
    Sweden
    Switzerland
    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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 260
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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