[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567107":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":44,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":19,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":19,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":19,"overallStatus":69,"whyStopped":19,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MWAV201","EXPERIMENTAL","All subjects will receive a single intravenous (IV) infusion of MWAV201.",[13],"Genetic: MWAV201",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"GENETIC","Nonreplicating, recombinant gene transfer vector",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Jian-Gao Fan, doctor","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","86-21-25077344","fanjiangao@xinhuamed.com.cn",[30],{"facility":5,"status":19,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Shanghai","Shanghai Municipality","200092","China","CN",{"type":37,"coordinates":38},"Point",[39,40],121.45806,31.22222,{"lat":40,"lon":39},[43],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},{"type":45,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[47],{"name":48,"class":49},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY","100567107","an-exploratory-study-to-evaluate-the-tolerability-and-safety-of-mwav201-in-subjects-with-wilson-disease-100567107",false,"NCT06663878","An Exploratory Study to Evaluate the Tolerability and Safety of MWAV201 in Subjects With Wilson Disease","An Open-Label, Dose Escalation Study to Evaluate the Tolerability, Safety, and Preliminary Efficacy of MWAV201 in Subjects With Wilson Disease","Inclusion Criteria:\n\n* Male or female aged 18 and 65 years inclusive;\n* Confirmed diagnosis of Wilson disease;\n* Low copper diet and standardized medication for ≥ 1 year;\n* Stable Wilson disease for ≥ 1 year;\n* Able to understand and willing to follow study procedures.\n\nExclusion Criteria:\n\n* Significant hepatic inflammation as evidenced by liver function test.\n* Liver biopsy or liver stiffness measurement show progressive liver fibrosis.\n* Laboratory tests or clinical symptoms indicate decreased liver reserve function.\n* Other chronic liver disease (such as hepatitis B).\n* Any signs of decompensated liver function (such as ascites).\n* History of liver transplant or plan to receive liver transplant.\n* Other diseases with clinical significance, such as cardiovascular and cerebrovascular diseases, kidney diseases, respiratory system diseases, neurological diseases, mental illnesses, active infections, etc.\n* Body Mass Index ≥ 30 kg\u002Fm2.\n* Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.","ALL","18 Years","65 Years",{"count":61,"type":62},9,"ESTIMATED","INTERVENTIONAL",[65],"NA","The primary objective of this study is to evaluate the tolerability and safety of MWAV201 in patients with Wilson disease.",[68],"Wilson Disease","NOT_YET_RECRUITING","2024-10-27",{"date":72,"type":73},"2024-10-29","ACTUAL",{"date":75,"type":62},"2024-10",{"date":77,"type":62},"2031-05",{"name":5,"class":6},1]