[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650510":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":20,"responsibleParty":35,"collaborators":20,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":20,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":20,"enrollmentInfo":46,"targetDuration":20,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":68,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":20},{"fullName":5,"class":6},"Shionogi Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"S-606001","EXPERIMENTAL","Participants will receive S-606001. Participants who were previously using enzyme replacement therapy (ERT) at the time of enrollment will receive the same regimen of ERT as standard of care.",[13,14],"Drug: S-606001","Drug: ERT",[16,21],{"type":17,"name":9,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","S-606001 will be administered orally.",[9],null,{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"ERT","ERT will be administered as an intravenous infusion.",[9],[26],{"name":27,"affiliation":5,"role":28},"Medical Director","STUDY_DIRECTOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":20,"email":34},"Shionogi Clinical Trials Administrator Clinical Support Help Line","CONTACT","1-800-849-9707","Shionogiclintrials-admin@shionogi.co.jp",{"type":36,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100650510","phase-2-an-extension-study-of-s-606001-in-participants-with-late-onset-pompe-disease-lopd-100650510",false,"NCT07750990","An Extension Study of S-606001 in Participants With Late-onset Pompe Disease (LOPD)","A Phase 2, Open-label, Multicenter, Extension Study to Investigate the Long-term Safety and Efficacy of S-606001 in Patients With Late-onset Pompe Disease","Key Inclusion Criteria:\n\n* Participant must be ≥40 kilograms of body weight at the time of signing the informed consent\n* Participants who previously completed a S-606001 Pompe treatment study, including participants whose assigned treatment arm was terminated by the sponsor\n\nKey Exclusion Criteria:\n\n* Has a medical condition or any other extenuating circumstance that may, in the opinion of the investigator or medical monitor, pose an undue safety risk to the participant or may compromise his\u002Fher ability to comply with or adversely impact protocol requirements\n* Current enrollment in any other clinical study involving an investigational intervention or any other type of medical research\n* Participant, if female, is pregnant or breastfeeding at visit 1\n* Participant, whether male or female, is planning to conceive a child during the study\n\nNote: Other protocol-specified inclusion and exclusion criteria may apply.","ALL","18 Years",{"count":47,"type":48},60,"ESTIMATED","INTERVENTIONAL",[51],"PHASE2","The primary purpose of this study is to evaluate the long-term safety and tolerability profile of S-606001 in participants with LOPD.\n\nParticipants who completed other S-606001 studies (for example, NCT07123155), including participants in a S-606001 study whose allocated arm was terminated by the sponsor and who are willing to participate in this study, will be enrolled globally.",[54],"Pompe Disease",[9,56,57,22,58,59,60,61,62,63,64,65,66,67],"Late-onset Pompe Disease","LOPD","Enzyme Replacement Therapy","NCT07123155","Muscle glycogen synthase","Liver glycogen synthase","Rare disease","Autosomal disease","Acid alpha-glucosidase","GAA","Glycogen storage disorder","GSD","NOT_YET_RECRUITING","2026-08-03",{"date":71,"type":72},"2026-08-06","ACTUAL",{"date":74,"type":48},"2026-08-31",{"date":76,"type":48},"2028-08-31",{"name":78,"class":6},"Shionogi"]