[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588356":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":40,"collaborators":11,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":11,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":11,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tafamidis Meglumine Soft Capsules","EXPERIMENTAL",null,[13],"Drug: Tafamidis Meglumine Soft Capsules",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","20 mg orally once daily for 72 weeks",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"chuanzhu yan, Doctor","CONTACT","18560082288","zzl2002@medmail.com",[26],{"facility":27,"status":28,"city":29,"state":11,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Qilu Hospital of Shandong University","RECRUITING","Jinan","China","CN",{"type":33,"coordinates":34},"Point",[35,36],116.99722,36.66833,{"lat":36,"lon":35},[39],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},{"type":41,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100588356","phase-4-to-evaluate-the-efficacy-and-safety-of-tafamidis-meglumine-soft-capsules-in-the-treatment-of-adult-patients-with-transthyretin-amyloid-polyneuropathy-100588356",false,"NCT06940336","To Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients With Transthyretin Amyloid Polyneuropathy","A Single Arm, Multicenter, Open-label,Phase IV Clinical Study to Evaluate the Efficacy and Safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients withTransthyretin Amyloid Polyneuropathy","Inclusion Criteria:\n\n* Male or female participants between the ages of 18 and 80 years.\n* Participant has amyloid deposits confirmed by biopsy (Biopsy must have been performed within 5 years prior to enrollment).\n* Participant must have a TTR mutation that is associated with ATTR-PN (TTR mutation test must have been performed within 5 years prior to enrollment).\n* Participant has peripheral neuropathy at screening.\n* Participant has a Karnofsky Performance Status Score ≥50.\n* Stages of disease according to symptom severity-stage 1.\n\nExclusion Criteria:\n\n* Participant has other causes of amyloidosis, such as light chain amyloidosis, AA amyloidosis.\n* Participant has used tafamidis within 2 months prior to enrollment.\n* Participant has used diflunisal, patisiran, inotersen, or other agents for familial amyloidosis within 30 days prior to enrollment or plan to use them during the study period.\n* Participant has used non-protocol NSAIDs more than 4 times within 30 days prior to enrollment or plan to use them more than 4 times per month during the study period.\n* Participant has used doxycycline,tauroursodeoxycholate within 14 days prior to enrollment or plan to use them during the study period.\n* Participant has sensory motor neuropathy caused by other causes, such as chronic inflammatory demyelinating polyradiculopathy, chronic idiopathic axonal neuropathy, diabetic neuropathy, chronic alcoholic neuropathy, paraneoplastic neuropathy,Guillain-Barre syndrome, vitamin B12 deficiency.\n* Participant has received liver or any other organ except cornea transplantation.","ALL","18 Years","80 Years",{"count":53,"type":54},15,"ESTIMATED","INTERVENTIONAL",[57],"PHASE4","The purpose of this study is to evaluate the efficacy and safety of Tafamidis Meglumine Soft Capsules in the Treatment of Adult Patients with Transthyretin Amyloid Polyneuropathy",[60],"Transthyretin Amyloid Polyneuropathy","2025-07-29",{"date":63,"type":64},"2025-07-30","ACTUAL",{"date":66,"type":64},"2025-06-19",{"date":68,"type":54},"2028-02",{"name":5,"class":6},1]