[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579070":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":29,"locations":34,"responsibleParty":91,"collaborators":23,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":23,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":23,"enrollmentInfo":102,"targetDuration":23,"studyType":105,"phases":106,"briefSummary":109,"conditions":110,"keywords":23,"overallStatus":112,"whyStopped":23,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Guangzhou Jiayin Biotech Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low dose arm","EXPERIMENTAL","EXG110 injection, use once by intravenous",[13],"Drug: EXG110 Injection",{"label":15,"type":10,"description":11,"interventionNames":16},"High dose arm",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","EXG110 Injection","EXG110 Injection is gene therapy for Fabry Disease , uses a proprietary AAV capsid with improved liver and muscle specificity.",[15,9],null,[25],{"name":26,"affiliation":27,"role":28},"Zhihong Liu, MD","The General Hospital of Eastern Theater Command","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":23,"email":33},"CONTACT","+86 137 0158 9469","chenpl166@163.com",[35,59,76],{"facility":36,"status":23,"city":37,"state":38,"zip":23,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"General Hospital of Eastern Theater Command","Nanjing","Jiangsu","China","CN",{"type":42,"coordinates":43},"Point",[44,45],118.77778,32.06167,{"lat":45,"lon":44},[48,50,51,54,56,58],{"name":49,"role":31,"phone":32,"phoneExt":23,"email":33},"Peiling Chen, MD",{"name":26,"role":28,"phone":23,"phoneExt":23,"email":23},{"name":52,"role":53,"phone":23,"phoneExt":23,"email":23},"Zhen Cheng, PhD","SUB_INVESTIGATOR",{"name":55,"role":53,"phone":23,"phoneExt":23,"email":23},"Yuanmao Tu, MD",{"name":57,"role":53,"phone":23,"phoneExt":23,"email":23},"Dandan Qiu, MD",{"name":49,"role":53,"phone":23,"phoneExt":23,"email":23},{"facility":60,"status":23,"city":61,"state":62,"zip":23,"country":39,"countryCode":40,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Children's Hospital Zhejiang University School of Medicine","Hangzhou","Zhejiang",{"type":42,"coordinates":64},[65,66],120.16142,30.29365,{"lat":66,"lon":65},[69,73,74],{"name":70,"role":31,"phone":71,"phoneExt":23,"email":72},"Jianhua Mao, PhD","+86 13616819071","maojh88@zju.edu.cn",{"name":70,"role":28,"phone":23,"phoneExt":23,"email":23},{"name":75,"role":53,"phone":23,"phoneExt":23,"email":23},"Zhihong Liu, PhD",{"facility":77,"status":23,"city":61,"state":62,"zip":23,"country":39,"countryCode":40,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"First Affiliated Hospital of Zhejiang University",{"type":42,"coordinates":79},[65,66],{"lat":66,"lon":65},[82,86,87,89],{"name":83,"role":31,"phone":84,"phoneExt":23,"email":85},"Xiaogang Guo, PhD","+86 13867741856","michelleyan2000@126.com",{"name":83,"role":28,"phone":23,"phoneExt":23,"email":23},{"name":88,"role":53,"phone":23,"phoneExt":23,"email":23},"Hui Yan, PhD",{"name":90,"role":53,"phone":23,"phoneExt":23,"email":23},"Pei Zhou, PhD",{"type":92,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100579070","phase-1-the-safety-and-efficacy-of-intravenous-exg110-in-patients-with-fabry-disease-100579070",false,"NCT06819514","The Safety and Efficacy of Intravenous EXG110 in Patients With Fabry Disease","A Phase 1\u002F2, Multicenter, Open-label,Dose-escalation Study to Evaluate the Safety and Efficacy of Intravenous EXG110 in Patients With Fabry Disease","Inclusion Criteria:\n\n1. Age ≥18 years old, male or female\n2. Clinical symptoms (at least one Fabry disease related symptom) and genetic diagnosis of Fabry disease\n3. Prior or no prior ERT treatment\n4. Have renal or cardiac involvement\n5. The participant voluntarily participate and are fully informed, fully understood the study, can comply with the requirements of the protocol, and voluntarily provide biological samples for testing according to the requirements of the protocol\n\nExclusion Criteria:\n\n1. Screening period laboratory test results: a) aspartate aminotransferase or alanine aminotransferase \\> 1.5× upper limit of normal (ULN);b) Total bilirubin \\> 1.5× upper limit of normal (ULN);c) Alkaline phosphatase \\> 2× upper limit of normal (ULN);d) Hypoalbuminemia ≥ grade 2\n2. Serum virology test: a) Hepatitis B: Hepatitis B virus surface antigen (HBsAg) positive, and hepatitis B virus-deoxyribonucleic acid (HBV-DNA) higher than the upper limit of normal detection;b) Hepatitis C: if the hepatitis C virus (HCV) antibody is positive, and the hepatitis C virus-ribonucleic acid (HCV-RNA) is higher than the upper limit of normal test value;c) Syphilis: positive for syphilis screening (Tp-Ab) and positive for syphile-specific antibodies;d) HIV: Known human immunodeficiency virus (HIV) positive history or HIV screening positive\n3. Current or have a history of serious cardiovascular disease and surgical history\n4. Current underlying liver disease or history of liver disease, as assessed by the investigator, that may affect the safety assessment of the product\n5. Acute\u002Fchronic infection or other chronic disease that the investigator evaluated will increase the risk of participants in the study\n6. Those who have a history of epilepsy, mental illness (such as schizophrenia, depression, mania or anxiety, etc.) or obvious mental disorders, and are incapacitated or cognitively incapacitated due to other reasons.\n7. Participant with a history of malignant tumor or currently suffering from any malignant tumor (except for the following tumor diseases: skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ , skin squamous cell carcinoma has been controlled after treatment);\n8. Participant with active autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, immune vasculitis, inflammatory bowel disease, etc.);\n9. known history of allergy to the components of the investigational products\n10. Participant with a history of drug use or drug abuse or alcoholism\n11. Has received, or currently receiving, a clinical trial of another investigational drug\u002Fmedical device or treatment (other than vitamins and minerals) within 3 months prior to signing the informed consent form (or within 5 half-lives of the investigational drug, whichever is longer)\n12. Previous treatment with gene therapy products\n13. Those who had received live attenuated vaccine\u002Fvaccine within 12 weeks prior to screening or planned to receive it during the study\n14. Other clinical conditions that the investigators evaluated needed to be excluded","ALL","18 Years",{"count":103,"type":104},16,"ESTIMATED","INTERVENTIONAL",[107,108],"PHASE1","PHASE2","A phase 1\u002F2, multicenter, open-label, Dose-escalation study to evaluate the safety and efficacy of intravenous EXG110 in patients with Fabry disease",[111],"Fabry Disease","NOT_YET_RECRUITING","2025-02-10",{"date":115,"type":116},"2025-02-11","ACTUAL",{"date":118,"type":104},"2025-03-01",{"date":120,"type":104},"2028-03-15",{"name":5,"class":6},3]