[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100294300":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":31,"responsibleParty":128,"collaborators":30,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":30,"eligibilityCriteria":136,"healthyVolunteers":137,"sex":138,"minAge":139,"maxAge":30,"enrollmentInfo":140,"targetDuration":30,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":30,"overallStatus":149,"whyStopped":30,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: EBR\u002FGZR for 8 Weeks","EXPERIMENTAL","Treatment-naïve participants with stage 0-2 fibrosis (F0-F2) receive FDC of EBR\u002FGZR (50 mg\u002F100 mg) for 8 weeks, with 24 weeks of follow-up.",[13],"Drug: EBR\u002FGZR (50 mg\u002F100 mg) FDC",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: EBR\u002FGZR for 12 Weeks","Treatment-naïve participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis receive FDC of EBR\u002FGZR (50 mg\u002F100 mg) for 12 weeks, with 24 weeks of follow-up.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","EBR\u002FGZR (50 mg\u002F100 mg) FDC","One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.",[9,15],[25],"MK-5172A",[27],{"name":28,"affiliation":5,"role":29},"Medical Director","STUDY_DIRECTOR",null,[32,43,51,59,62,70,78,86,94,102,107,112,120],{"facility":33,"status":30,"city":34,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":30},"CHU Amiens-Picardie - Hopital Sud ( Site 0217)","Amiens","France","FR",{"type":38,"coordinates":39},"Point",[40,41],2.3,49.9,{"lat":41,"lon":40},{"facility":44,"status":30,"city":45,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":46,"geoPoint":50,"contacts":30},"CHU Jean Minjoz ( Site 0213)","Besançon",{"type":38,"coordinates":47},[48,49],6.01815,47.24878,{"lat":49,"lon":48},{"facility":52,"status":30,"city":53,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":54,"geoPoint":58,"contacts":30},"CHU Henri Mondor ( Site 0206)","Créteil",{"type":38,"coordinates":55},[56,57],2.46569,48.79266,{"lat":57,"lon":56},{"facility":60,"status":30,"city":61,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"CHU de Grenoble - Hopital Michallon ( Site 0208)","Genoble",{"facility":63,"status":30,"city":64,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":65,"geoPoint":69,"contacts":30},"CHU Dupuytren ( Site 0209)","Limoges",{"type":38,"coordinates":66},[67,68],1.24759,45.83362,{"lat":68,"lon":67},{"facility":71,"status":30,"city":72,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":73,"geoPoint":77,"contacts":30},"Hopital Saint Eloi ( Site 0207)","Montpellier",{"type":38,"coordinates":74},[75,76],3.87635,43.61093,{"lat":76,"lon":75},{"facility":79,"status":30,"city":80,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":81,"geoPoint":85,"contacts":30},"C.H.U. de Nice Hopital de l Archet 2 ( Site 0215)","Nice",{"type":38,"coordinates":82},[83,84],7.26608,43.70313,{"lat":84,"lon":83},{"facility":87,"status":30,"city":88,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":89,"geoPoint":93,"contacts":30},"Centre Hospitalier Regional du Orleans ( Site 0212)","Orléans",{"type":38,"coordinates":90},[91,92],1.90407,47.90248,{"lat":92,"lon":91},{"facility":95,"status":30,"city":96,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":97,"geoPoint":101,"contacts":30},"Hopital Beaujon ( Site 0201)","Paris",{"type":38,"coordinates":98},[99,100],2.3488,48.85341,{"lat":100,"lon":99},{"facility":103,"status":30,"city":96,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":104,"geoPoint":106,"contacts":30},"Hopital Cochin ( Site 0211)",{"type":38,"coordinates":105},[99,100],{"lat":100,"lon":99},{"facility":108,"status":30,"city":96,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":109,"geoPoint":111,"contacts":30},"Hopital Saint Antoine ( Site 0200)",{"type":38,"coordinates":110},[99,100],{"lat":100,"lon":99},{"facility":113,"status":30,"city":114,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":115,"geoPoint":119,"contacts":30},"CHU de Toulouse - Hopital Purpan ( Site 0216)","Toulouse",{"type":38,"coordinates":116},[117,118],1.44367,43.60426,{"lat":118,"lon":117},{"facility":121,"status":30,"city":122,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":123,"geoPoint":127,"contacts":30},"CHU de Nancy Hopital Brabois Adultes ( Site 0204)","Vandœuvre-lès-Nancy",{"type":38,"coordinates":124},[125,126],6.17114,48.66115,{"lat":126,"lon":125},{"type":129,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100294300","phase-4-efficacy-and-safety-of-elbasvir-mk-8742--grazoprevir-mk-5172-in-treatment-navetreatment-experienced-tnte-french-participants-with-hepatitis-c-virus-hcv-genotype-4-gt4-infection-mk-5172-096-100294300",true,"NCT03111108","Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve\u002FTreatment-Experienced (TN\u002FTE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096)","A Multi-Site, Open-Label, Partially-Randomized Trial of the Efficacy and Safety of Fixed Dose Elbasvir\u002FGrazoprevir (EBR\u002FGZR) Based Regimens in French Subjects With Chronic Hepatitis C Virus (HCV) Genotype 4 Infection","Inclusion Criteria:\n\n* Be a current resident of France\n* Have HCV RNA (≥ 10,000 IU\u002FmL in peripheral blood) at the time of screening\n* Have documented chronic HCV GT4 (with no evidence of non-typeable or mixed genotype) infection\n* Have liver biopsy performed within 24 months of Day 1 of this study (if participant has cirrhosis, there is no time restriction on biopsy), or have FibroScan® performed within 12 months of Day 1 of this study with interpretable result in kilopascals (kPa) as follows: Fibrosis score of F0-F2, Fibrosis score of F3, or Cirrhosis (F4)\n* Have a prior treatment history of either HCV TN or HCV TE with interferon (IFN) +\u002F- ribavirin (RBV) +\u002F- Sofosbuvir (SOF) (on-treatment failure, relapser, or other\u002Fintolerant)\n* Females who are of reproductive potential must agree to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug 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\n* If Human Immunodeficiency Virus (HIV) co-infected, then have HIV-1 infection documented prior to screening\n\nExclusion Criteria:\n\n* Had prior treatment (defined as 1 dose or more) with direct-acting antiviral (DAA) therapy\n* 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\n* Classified as Child-Pugh B or C or has a Child Pugh-Turcotte score (CPT) \\> 6\n* Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC\n* Hepatitis B virus surface antigen (HBsAg) positive at screening. Participants who are HBsAg negative and hepatitis B core antibody (anti-HBc) positive at screening may be included\n* Under evaluation for active or suspected malignancy, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer 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",false,"ALL","18 Years",{"count":141,"type":142},117,"ACTUAL","INTERVENTIONAL",[145],"PHASE4","The purpose of this study was to evaluate the efficacy of 8 and 12 weeks of treatment with a fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A) as assessed by the percentage of participants with hepatitis C virus (HCV) genotype (GT) 4 infection that achieve sustained virologic response (HCV ribonucleic acid \\[RNA\\] \\\u003C Lower Limit of Quantification \\[LLOQ\\]) 12 weeks after the end of study therapy (SVR12). This study also evaluated the safety and tolerability of EBR\u002FGZR.",[148],"Hepatitis C Virus (HCV) Infection","COMPLETED","2020-05-28",{"date":152,"type":142},"2020-06-09",{"date":154,"type":142},"2017-06-20",{"date":156,"type":142},"2018-10-15",{"name":5,"class":6},13]