{
  "FullStudy":{
    "Rank":217910,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515241",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CER-001-CLIN-005"
          },
          "Organization":{
            "OrgFullName":"Cerenis Therapeutics, SA",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Exploratory Study of Plaque Regression",
          "OfficialTitle":"EXPLORATORY STUDY OF PLAQUE REGRESSION:A Phase II Single Center Open-Label Exploratory Trial of the Effect of CER 001 in Subjects With Familial Hypercholesterolemia",
          "Acronym":"EXPRESS"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "DispFirstSubmitDate":"January 29, 2014",
          "DispFirstSubmitQCDate":"January 29, 2014",
          "DispFirstPostDateStruct":{
            "DispFirstPostDate":"March 3, 2014",
            "DispFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 29, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 3, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Cerenis Therapeutics, SA",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Despite the availability of several classes of very effective drugs available to treat heterozygous Familial Hypercholesterolemia (HeFH), there remains a large unmet medical need for new, effective and well tolerated therapies. There are a number of therapies given on a chronic basis to reduce long term risk, such as statins, fibrates, niacin, omega 3 fatty acids, resins, cholesterol absorption inhibitors and antiplatelet or anticoagulant drugs, but subjects with heterozygous Familial Hypercholesterolemia remain at high risk for cardiovascular events. There is still a need for acute therapies that can lead to rapid pacification of unstable plaque in order to reduce the risk of these events. This study will assess the effects of CER-001 , a recombinant human Apo-A-1 based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by 3Tesla MRI (3TMRI)and intravascular ultrasound (IVUS) evaluations in patients with HeFH."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Heterozygous Familial Hypercholesterolemia"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Heterozygous Familial Hypercholesterolemia",
              "Familial Hypercholesterolemia",
              "HDL mimetic",
              "ApoA-1"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"10",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Open label single arm study of CER-001",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"Open label single arm study of CER-001",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: CER-001"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"CER-001",
                "InterventionDescription":"Weekly injection",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Open label single arm study of CER-001"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change in Total Plaque Volume",
                "PrimaryOutcomeDescription":"Nominal change in total plaque volume (ACTPV), as assessed by 3D IVUS, from the baseline measurement to the follow-up taken ~3 weeks following the final dose of study medication (approximately 10 weeks after the baseline assessment)",
                "PrimaryOutcomeTimeFrame":"Baseline and 3 weeks post final dose"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Percent Change in Plaque Volume",
                "SecondaryOutcomeDescription":"Percent change in total plaque volume (PCTPV), as assessed by IVUS, from the baseline measurement to the follow up taken approximately 3 weeks following the final dose of study medication (approximately 10 weeks after the baseline assessment)",
                "SecondaryOutcomeTimeFrame":"Baseline and 3 weeks post final dose"
              },{
                "SecondaryOutcomeMeasure":"Change in carotid plaque volume",
                "SecondaryOutcomeDescription":"Percent change in total carotid plaque volume, as assessed by 3TMRI, from the baseline measurement to the follow up taken approximately 3 weeks following the final dose of study medication",
                "SecondaryOutcomeTimeFrame":"Baseline and 3 weeks post final dose"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMale or Female subjects at least 18 years old\nSubject presents heterozygous FH, known CHD and receiving maximally tolerated lipid modifying therapy, at stable doses for at least 3 months\nLDL-C of > 110 mg/dl\nAngiographic evidence of coronary artery disease with suitable \"target\" coronary artery for IVUS\n\nExclusion Criteria:\n\nConfirmed diagnosis of homozygous FH\nSignificant health problems (other than cardiovascular disease) in the recent past including blood disorders, cancer, or digestive problems\nFemale subjects not meeting the study definition of non child-bearing potential\nUse of an investigational agent within 30 days of the first CER-001 dose\nReceiving current lipid apheresis",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jean-Claude Tardif, MD",
                "OverallOfficialAffiliation":"Montreal Heart Institute",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Montreal Heart Institute",
                "LocationCity":"Montreal",
                "LocationState":"Quebec",
                "LocationZip":"H1T1C8",
                "LocationCountry":"Canada"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"10441095",
                "ReferenceType":"background",
                "ReferenceCitation":"Eriksson M, Carlson LA, Miettinen TA, Angelin B. Stimulation of fecal steroid excretion after infusion of recombinant proapolipoprotein A-I. Potential reverse cholesterol transport in humans. Circulation. 1999 Aug 10;100(6):594-8."
              },{
                "ReferencePMID":"10195926",
                "ReferenceType":"background",
                "ReferenceCitation":"Nanjee MN, Doran JE, Lerch PG, Miller NE. Acute effects of intravenous infusion of ApoA1/phosphatidylcholine discs on plasma lipoproteins in humans. Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):979-89."
              },{
                "ReferencePMID":"11914243",
                "ReferenceType":"background",
                "ReferenceCitation":"Spieker LE, Sudano I, Hürlimann D, Lerch PG, Lang MG, Binggeli C, Corti R, Ruschitzka F, Lüscher TF, Noll G. High-density lipoprotein restores endothelial function in hypercholesterolemic men. Circulation. 2002 Mar 26;105(12):1399-402."
              },{
                "ReferencePMID":"18389214",
                "ReferenceType":"background",
                "ReferenceCitation":"Nieuwdorp M, Vergeer M, Bisoendial RJ, op 't Roodt J, Levels H, Birjmohun RS, Kuivenhoven JA, Basser R, Rabelink TJ, Kastelein JJ, Stroes ES. Reconstituted HDL infusion restores endothelial function in patients with type 2 diabetes mellitus. Diabetologia. 2008 Jun;51(6):1081-4. doi: 10.1007/s00125-008-0975-2. Epub 2008 Apr 4."
              },{
                "ReferencePMID":"18832751",
                "ReferenceType":"background",
                "ReferenceCitation":"Shaw JA, Bobik A, Murphy A, Kanellakis P, Blombery P, Mukhamedova N, Woollard K, Lyon S, Sviridov D, Dart AM. Infusion of reconstituted high-density lipoprotein leads to acute changes in human atherosclerotic plaque. Circ Res. 2008 Nov 7;103(10):1084-91. doi: 10.1161/CIRCRESAHA.108.182063. Epub 2008 Oct 2."
              },{
                "ReferencePMID":"14600188",
                "ReferenceType":"background",
                "ReferenceCitation":"Nissen SE, Tsunoda T, Tuzcu EM, Schoenhagen P, Cooper CJ, Yasin M, Eaton GM, Lauer MA, Sheldon WS, Grines CL, Halpern S, Crowe T, Blankenship JC, Kerensky R. Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial. JAMA. 2003 Nov 5;290(17):2292-300."
              },{
                "ReferencePMID":"17387133",
                "ReferenceType":"background",
                "ReferenceCitation":"Tardif JC, Grégoire J, L'Allier PL, Ibrahim R, Lespérance J, Heinonen TM, Kouz S, Berry C, Basser R, Lavoie MA, Guertin MC, Rodés-Cabau J; Effect of rHDL on Atherosclerosis-Safety and Efficacy (ERASE) Investigators. Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial. JAMA. 2007 Apr 18;297(15):1675-82. Epub 2007 Mar 26."
              },{
                "ReferencePMID":"20538165",
                "ReferenceType":"background",
                "ReferenceCitation":"Waksman R, Torguson R, Kent KM, Pichard AD, Suddath WO, Satler LF, Martin BD, Perlman TJ, Maltais JA, Weissman NJ, Fitzgerald PJ, Brewer HB Jr. A first-in-man, randomized, placebo-controlled study to evaluate the safety and feasibility of autologous delipidated high-density lipoprotein plasma infusions in patients with acute coronary syndrome. J Am Coll Cardiol. 2010 Jun 15;55(24):2727-35. doi: 10.1016/j.jacc.2009.12.067."
              }
            ]
          }
        }
      },
      "ResultsSection":{
        "MoreInfoModule":{}
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006938",
                "ConditionMeshTerm":"Hyperlipoproteinemia Type II"
              },{
                "ConditionMeshId":"D000006937",
                "ConditionMeshTerm":"Hypercholesterolemia"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000006949",
                "ConditionAncestorTerm":"Hyperlipidemias"
              },{
                "ConditionAncestorId":"D000050171",
                "ConditionAncestorTerm":"Dyslipidemias"
              },{
                "ConditionAncestorId":"D000052439",
                "ConditionAncestorTerm":"Lipid Metabolism Disorders"
              },{
                "ConditionAncestorId":"D000008659",
                "ConditionAncestorTerm":"Metabolic Diseases"
              },{
                "ConditionAncestorId":"D000008052",
                "ConditionAncestorTerm":"Lipid Metabolism, Inborn Errors"
              },{
                "ConditionAncestorId":"D000008661",
                "ConditionAncestorTerm":"Metabolism, Inborn Errors"
              },{
                "ConditionAncestorId":"D000030342",
                "ConditionAncestorTerm":"Genetic Diseases, Inborn"
              },{
                "ConditionAncestorId":"D000006951",
                "ConditionAncestorTerm":"Hyperlipoproteinemias"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8571",
                "ConditionBrowseLeafName":"Hypercholesterolemia",
                "ConditionBrowseLeafAsFound":"Hypercholesterolemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M8583",
                "ConditionBrowseLeafName":"Hyperlipidemias",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8585",
                "ConditionBrowseLeafName":"Hyperlipoproteinemias",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8572",
                "ConditionBrowseLeafName":"Hyperlipoproteinemia Type II",
                "ConditionBrowseLeafAsFound":"Familial Hypercholesterolemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M24768",
                "ConditionBrowseLeafName":"Dyslipidemias",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10222",
                "ConditionBrowseLeafName":"Metabolic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M25616",
                "ConditionBrowseLeafName":"Lipid Metabolism Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10224",
                "ConditionBrowseLeafName":"Metabolism, Inborn Errors",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9637",
                "ConditionBrowseLeafName":"Lipid Metabolism, Inborn Errors",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M22270",
                "ConditionBrowseLeafName":"Genetic Diseases, Inborn",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC16",
                "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth"
              }
            ]
          }
        }
      }
    }
  }
}