[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529380":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":18,"centralContacts":22,"locations":7,"responsibleParty":28,"collaborators":7,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":7,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":7,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":38,"phases":7,"briefSummary":39,"conditions":40,"keywords":42,"overallStatus":44,"whyStopped":7,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":49,"locationsCount":7},{"fullName":5,"class":6},"Takeda","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"BIOLOGICAL","TAK-577","TAK-577 as IV injection at dose calculated based on the participant's body weight.",[14,15,16,17],"Recombinant von Willebrand factor (rVWF)","Vonvendi","Vonicog alfa","VEYVONDI",[19],{"name":20,"affiliation":5,"role":21},"Study Director","STUDY_DIRECTOR",[23],{"name":24,"role":25,"phone":26,"phoneExt":7,"email":27},"Takeda Contact","CONTACT","+1-877-825-3327","medinfoUS@takeda.com",{"type":29,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100529380","post-trial-access-program-of-tak-577-for-von-willebrand-disease-vwd-100529380",false,"NCT06173024","Post Trial Access Program of TAK-577 for Von Willebrand Disease (VWD)","Post Trial Access for Study SHP677-304: Recombinant Von Willebrand Factor (rVWF) for Adult and Pediatric Subjects With Severe Von Willebrand Disease (VWD)","Inclusion Criteria:\n\n1. Participant has completed the treatment period of the SHP677-304 study (at least 12 months on study treatment).\n2. Participant had good clinical response to rVWF treatment.\n3. Participant does not have access to any comparable or satisfactory alternative replacement therapy available at country level.\n4. Participant will be\u002Fhas been negatively impacted by discontinuation of rVWF.\n5. Participant and\u002For a parent(s)\u002Flegal guardian is informed of the nature of the post-trial access program and can provide written informed consent for themselves or the child to participate (with assent from a child when appropriate) before treatment).\n\nExclusion Criteria:\n\n1\\. Participants with known hypersensitivity\u002Fintolerance to the study drug will not be eligible for this study","ALL","EXPANDED_ACCESS","The post-trial access program allows eligible participants to gain access to unlicensed treatment on compassionate grounds. Recombinant von Willebrand factor (rVWF) also known as TAK-577, is a medicine to help treat Von Willebrand Disease (VWD). This post-trial access program enables continued access to children and adults who are benefitting from treatment on study SHP677-304 (NCT03879135) study.",[41],"Von Willebrand Disease (VWD)",[43],"Drug Therapy","AVAILABLE","2025-09-02",{"date":47,"type":48},"2025-09-03","ACTUAL",{"name":5,"class":6}]