[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100225982":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":44,"centralContacts":43,"locations":43,"responsibleParty":48,"collaborators":43,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":43,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":80,"whyStopped":43,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":43},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: GT1B","EXPERIMENTAL","ombitasvir\u002Fparitaprevir\u002Fritonavir 25\u002F150\u002F100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants",[13,14,15],"Drug: ombitasvir\u002Fparitaprevir\u002Fritonavir","Drug: dasabuvir","Drug: ribavirin",{"label":17,"type":10,"description":18,"interventionNames":19},"Group 2: GT1 Non-B","ombitasvir\u002Fparitaprevir\u002Fritonavir 25\u002F150\u002F100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Group 3: GT4","ombitasvir\u002Fparitaprevir\u002Fritonavir 25\u002F150\u002F100 mg QD + RBV for 24 weeks in HCV GT4-infected participants",[13,15],[25,34,40],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","ombitasvir\u002Fparitaprevir\u002Fritonavir","tablet; paritaprevir co-formulated with ritonavir and ombitasvir",[9,17,21],[31,32,33],"ABT-267 also known as ombitasvir","ABT-450 also known as paritaprevir","ritonavir also known as norvir",{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"dasabuvir","tablet",[9,17],[39],"ABT-333",{"type":26,"name":41,"description":36,"armGroupLabels":42,"otherNames":43},"ribavirin",[9,17,21],null,[45],{"name":46,"affiliation":5,"role":47},"Eric Cohen, MD","STUDY_DIRECTOR",{"type":49,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100225982","phase-3-a-study-to-evaluate-the-safety-and-efficacy-of-ombitasvirparitaprevirritonavir-and-dasabuvir-with-ribavirin-in-adults-with-genotype-1-and-ombitasvirparitaprevirritonavir-with-ribavirin-in-adults-with-genotype-4-chronic-hepatitis-c-virus-infection-and-decompensated-cirrhosis-100225982",true,"NCT02219477","A Study to Evaluate the Safety and Efficacy of Ombitasvir\u002FParitaprevir\u002FRitonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir\u002FParitaprevir\u002FRitonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis","An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir\u002FParitaprevir\u002FRitonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir\u002FParitaprevir\u002FRitonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis (TURQUOISE-CPB)","TURQUOISE-CPB","Inclusion Criteria:\n\n1. HCV GT1- or GT4-infection defined as: positive for anti-HCV Ab, HCV RNA \\> 1,000 IU\u002FmL and laboratory result indicating HCV GT1 or GT4 infection at Screening.\n2. Evidence of cirrhosis by prior liver biopsy, FibroScan or by radiograph (i.e., computed tomography \\[CT\\] scan or magnetic resonance imaging \\[MRI\\]).\n3. Child-Pugh Score of 7 - 9, inclusive, at time of Screening.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding.\n2. Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab).\n3. Prior or current use of any other investigational or commercially available anti-HCV agents other than interferon\u002FRBV and\u002For pegylated interferon (pegIFN)\u002FRBV (including but not limited to telaprevir, boceprevir, sofosbuvir and simeprevir).\n4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as CT scan or MRI within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI).\n5. Any current or past evidence of Child-Pugh C classification.",false,"ALL","18 Years","99 Years",{"count":63,"type":64},36,"ACTUAL","INTERVENTIONAL",[67],"PHASE3","The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir\u002Fparitaprevir\u002Fritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.",[70,71,72],"Chronic Hepatitis C","Decompensated Cirrhosis","Hepatitis C Virus",[74,75,76,77,78,79,70,71,72],"Cirrhosis","Hepatitis C","Child-Pugh B","Hepatitis C Genotype 4","Interferon-Free","Hepatitis C Genotype 1","COMPLETED","2017-06-09",{"date":83,"type":64},"2017-07-11",{"date":85,"type":64},"2014-11-24",{"date":87,"type":64},"2017-03-03",{"name":5,"class":6}]