{ "FullStudy":{ "Rank":217781, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516918", "OrgStudyIdInfo":{ "OrgStudyId":"VX11-222-106" }, "Organization":{ "OrgFullName":"Vertex Pharmaceuticals Incorporated", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis", "OfficialTitle":"A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis" }, "StatusModule":{ "StatusVerifiedDate":"October 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "DispFirstSubmitDate":"October 9, 2014", "DispFirstSubmitQCDate":"October 9, 2014", "DispFirstPostDateStruct":{ "DispFirstPostDate":"October 20, 2014", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"October 9, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 20, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Vertex Pharmaceuticals Incorporated", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Chronic Hepatitis C Virus" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"103", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Quadruple Regimen", "ArmGroupType":"Experimental", "ArmGroupDescription":"All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: VX-222", "Drug: telaprevir", "Drug: ribavirin", "Biological: peginterferon-alfa-2a" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"VX-222", "InterventionDescription":"tablet, 400-mg twice daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Quadruple Regimen" ] } },{ "InterventionType":"Drug", "InterventionName":"telaprevir", "InterventionDescription":"tablet, 1125-mg twice daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Quadruple Regimen" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Incivek, VX-950, Incivo" ] } },{ "InterventionType":"Drug", "InterventionName":"ribavirin", "InterventionDescription":"tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Quadruple Regimen" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Copegus" ] } },{ "InterventionType":"Biological", "InterventionName":"peginterferon-alfa-2a", "InterventionDescription":"subcutaneous injection, 180-mcg, once weekly", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Quadruple Regimen" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Pegasys" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)", "PrimaryOutcomeTimeFrame":"12 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.", "SecondaryOutcomeTimeFrame":"up to 48 weeks" },{ "SecondaryOutcomeMeasure":"The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)", "SecondaryOutcomeTimeFrame":"24 weeks" },{ "SecondaryOutcomeMeasure":"The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment", "SecondaryOutcomeTimeFrame":"up to week 12" },{ "SecondaryOutcomeMeasure":"The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment", "SecondaryOutcomeTimeFrame":"up to 48 weeks" },{ "SecondaryOutcomeMeasure":"The association of the IL-28B genotype with SVR12", "SecondaryOutcomeDescription":"Proportion of subjects who have SVR12 by IL-28B genotype", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure", "SecondaryOutcomeDescription":"The identity and observed frequency of viral variants as compared to wild-type virus will be measured.", "SecondaryOutcomeTimeFrame":"After the last planned dose of study drug or after time of failure" },{ "SecondaryOutcomeMeasure":"VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations", "SecondaryOutcomeTimeFrame":"12 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects must have genotype 1 Chronic Hepatitis C\nSubjects must have compensated cirrhosis\nSubjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered\nSubjects with hemophilia may be permitted to enroll with permission of the medical monitor\n\nExclusion Criteria:\n\nAny previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor\nAny contraindication to Peg-IFN or RBV therapy\nEvidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices\nA history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Medical Monitor", "OverallOfficialAffiliation":"Vertex Pharmaceuticals Incorporated", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Birmingham", "LocationState":"Alabama", "LocationCountry":"United States" },{ "LocationCity":"San Diego", "LocationState":"California", "LocationCountry":"United States" },{ "LocationCity":"Englewood", "LocationState":"Colorado", "LocationCountry":"United States" },{ "LocationCity":"Bradenton", "LocationState":"Florida", "LocationCountry":"United States" },{ "LocationCity":"Jacksonville", "LocationState":"Florida", "LocationCountry":"United States" },{ "LocationCity":"Tampa", "LocationState":"Florida", "LocationCountry":"United States" },{ "LocationCity":"Marietta", "LocationState":"Georgia", "LocationCountry":"United States" },{ "LocationCity":"Chicago", "LocationState":"Illinois", "LocationCountry":"United States" },{ "LocationCity":"Indianapolis", "LocationState":"Indiana", "LocationCountry":"United States" },{ "LocationCity":"Boston", "LocationState":"Massachusetts", "LocationCountry":"United States" },{ "LocationCity":"Detroit", "LocationState":"Michigan", "LocationCountry":"United States" },{ "LocationCity":"Lebanon", "LocationState":"New Hampshire", "LocationCountry":"United States" },{ "LocationCity":"Egg Harbor Township", "LocationState":"New Jersey", "LocationCountry":"United States" },{ "LocationCity":"Manhasset", "LocationState":"New York", "LocationCountry":"United States" },{ "LocationCity":"New York", "LocationState":"New York", "LocationCountry":"United States" },{ "LocationCity":"Rochester", "LocationState":"New York", "LocationCountry":"United States" },{ "LocationCity":"Asheville", "LocationState":"North Carolina", "LocationCountry":"United States" },{ "LocationCity":"Charlotte", "LocationState":"North Carolina", "LocationCountry":"United States" },{ "LocationCity":"Durham", "LocationState":"North Carolina", "LocationCountry":"United States" },{ "LocationCity":"Cincinnati", "LocationState":"Ohio", "LocationCountry":"United States" },{ "LocationCity":"Providence", "LocationState":"Rhode Island", "LocationCountry":"United States" },{ "LocationCity":"Germantown", "LocationState":"Tennessee", "LocationCountry":"United States" },{ "LocationCity":"Arlington", "LocationState":"Texas", "LocationCountry":"United States" },{ "LocationCity":"Houston", "LocationState":"Texas", "LocationCountry":"United States" },{ "LocationCity":"San Antonio", "LocationState":"Texas", "LocationCountry":"United States" },{ "LocationCity":"Norfolk", "LocationState":"Virginia", "LocationCountry":"United States" },{ "LocationCity":"Madison", "LocationState":"Wisconsin", "LocationCountry":"United States" },{ "LocationCity":"Milwaukee", "LocationState":"Wisconsin", "LocationCountry":"United States" },{ "LocationCity":"Vancouver", "LocationState":"British Columbia", "LocationCountry":"Canada" },{ "LocationCity":"London", "LocationState":"Ontario", "LocationCountry":"Canada" },{ "LocationCity":"Montreal", "LocationState":"Quebec", "LocationCountry":"Canada" },{ "LocationCity":"Hamburg", "LocationCountry":"Germany" },{ "LocationCity":"Heidelberg", "LocationCountry":"Germany" },{ "LocationCity":"Hessen", "LocationCountry":"Germany" },{ "LocationCity":"Koeln", "LocationCountry":"Germany" },{ "LocationCity":"Saschen", "LocationCountry":"Germany" },{ "LocationCity":"Stuttgart", "LocationCountry":"Germany" },{ "LocationCity":"Bialystok", "LocationCountry":"Poland" },{ "LocationCity":"Myslowice", "LocationCountry":"Poland" },{ "LocationCity":"Wroclaw", "LocationCountry":"Poland" },{ "LocationCity":"London", "LocationCountry":"United Kingdom" },{ "LocationCity":"Plymouth", "LocationCountry":"United Kingdom" },{ "LocationCity":"Scotland", "LocationCountry":"United Kingdom" } ] } } }, "ResultsSection":{ "MoreInfoModule":{} }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "Australia", "Belgium" ] } }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000012254", "InterventionMeshTerm":"Ribavirin" },{ "InterventionMeshId":"C000100416", "InterventionMeshTerm":"Peginterferon alfa-2a" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000963", "InterventionAncestorTerm":"Antimetabolites" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000000998", "InterventionAncestorTerm":"Antiviral Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M13666", "InterventionBrowseLeafName":"Ribavirin", "InterventionBrowseLeafAsFound":"Ribavirin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M255637", "InterventionBrowseLeafName":"Peginterferon alfa-2a", "InterventionBrowseLeafAsFound":"Peginterferon alfa-2a", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2862", "InterventionBrowseLeafName":"Antimetabolites", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2895", "InterventionBrowseLeafName":"Antiviral Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006506", "ConditionMeshTerm":"Hepatitis A" },{ "ConditionMeshId":"D000006526", "ConditionMeshTerm":"Hepatitis C" },{ "ConditionMeshId":"D000019698", "ConditionMeshTerm":"Hepatitis C, Chronic" },{ "ConditionMeshId":"D000006505", "ConditionMeshTerm":"Hepatitis" },{ "ConditionMeshId":"D000006521", "ConditionMeshTerm":"Hepatitis, Chronic" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000008107", "ConditionAncestorTerm":"Liver Diseases" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000006525", "ConditionAncestorTerm":"Hepatitis, Viral, Human" },{ "ConditionAncestorId":"D000014777", "ConditionAncestorTerm":"Virus Diseases" },{ "ConditionAncestorId":"D000004769", "ConditionAncestorTerm":"Enterovirus Infections" },{ "ConditionAncestorId":"D000010850", "ConditionAncestorTerm":"Picornaviridae Infections" },{ "ConditionAncestorId":"D000012327", "ConditionAncestorTerm":"RNA Virus Infections" },{ "ConditionAncestorId":"D000018178", "ConditionAncestorTerm":"Flaviviridae Infections" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M9686", "ConditionBrowseLeafName":"Liver Cirrhosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8174", "ConditionBrowseLeafName":"Hepatitis", "ConditionBrowseLeafAsFound":"Hepatitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M16105", "ConditionBrowseLeafName":"Virus Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8175", "ConditionBrowseLeafName":"Hepatitis A", "ConditionBrowseLeafAsFound":"Hepatitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8194", "ConditionBrowseLeafName":"Hepatitis C", "ConditionBrowseLeafAsFound":"Hepatitis C", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20197", "ConditionBrowseLeafName":"Hepatitis C, Chronic", "ConditionBrowseLeafAsFound":"Chronic Hepatitis C", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8190", "ConditionBrowseLeafName":"Hepatitis, Chronic", "ConditionBrowseLeafAsFound":"Chronic Hepatitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9690", "ConditionBrowseLeafName":"Liver Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8193", "ConditionBrowseLeafName":"Hepatitis, Viral, Human", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6513", "ConditionBrowseLeafName":"Enterovirus Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M12328", "ConditionBrowseLeafName":"Picornaviridae Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13732", "ConditionBrowseLeafName":"RNA Virus Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18907", "ConditionBrowseLeafName":"Flaviviridae Infections", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC02", "ConditionBrowseBranchName":"Viral Diseases" },{ "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" } ] } } } } } }