[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522976":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":19,"locations":25,"responsibleParty":77,"collaborators":10,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":10,"enrollmentInfo":89,"targetDuration":10,"studyType":92,"phases":10,"briefSummary":93,"conditions":94,"keywords":10,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Ipsen","INDUSTRY",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Exposed Cohort",null,"Participants treated with palovarotene (i.e already be receiving palovarotene as prescribed by their treating physician according to locally approved product information)",{"label":13,"type":10,"description":14,"interventionNames":10},"Unexposed Cohort","Participants untreated with palovarotene",[16],{"name":17,"affiliation":5,"role":18},"Ipsen Medical, Director","STUDY_DIRECTOR",[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Ipsen Clinical Study Enquiries","CONTACT","see email","clinical.trials@ipsen.com",[26,40,50,60,69],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":10},"The Regents of the University of California","RECRUITING","San Francisco","California","94103","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-122.41942,37.77493,{"lat":38,"lon":37},{"facility":41,"status":28,"city":42,"state":43,"zip":44,"country":32,"countryCode":33,"cosmosGeoPoint":45,"geoPoint":49,"contacts":10},"The Trustees of the University of Pennsylvania, Office of Clinical Research-Legal Services, Perelman School of Medicine","Philadelphia","Pennsylvania","19104",{"type":35,"coordinates":46},[47,48],-75.16362,39.95238,{"lat":48,"lon":47},{"facility":51,"status":28,"city":52,"state":10,"zip":10,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":10},"Edmonton Clinic Health Academy (ECHA)- University of Alberta","Edmonton","Canada","CA",{"type":35,"coordinates":56},[57,58],-113.46871,53.55014,{"lat":58,"lon":57},{"facility":61,"status":62,"city":63,"state":10,"zip":10,"country":53,"countryCode":54,"cosmosGeoPoint":64,"geoPoint":68,"contacts":10},"Bone Research and Education Centre","ACTIVE_NOT_RECRUITING","Oakville",{"type":35,"coordinates":65},[66,67],-79.68292,43.45011,{"lat":67,"lon":66},{"facility":70,"status":28,"city":71,"state":10,"zip":10,"country":53,"countryCode":54,"cosmosGeoPoint":72,"geoPoint":76,"contacts":10},"University Health Network (UHN) - Toronto General","Toronto",{"type":35,"coordinates":73},[74,75],-79.39864,43.70643,{"lat":75,"lon":74},{"type":78,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100522976","a-study-to-document-and-to-further-describe-long-term-safety-and-effectiveness-of-palovarotene-in-participants-with-fibrodysplasia-ossificans-progressiva-fop-100522976",false,"NCT06089616","A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)","An International Observational Registry Study to Further Describe Long-term Safety and Effectiveness of Palovarotene in Patients With Fibrodysplasia Ossificans Progressiva (FOP)","FOPal","Inclusion Criteria :\n\n* Adult or child with FOP who have been prescribed palovarotene (prior to and independently of the decision to enroll the patient in this registry study and as per local label) by their treating physician according to the locally approved product information;\n* Signed informed consent as per local regulations must be obtained and maintained. Consent\u002Fassent from the participant should be obtained as appropriate before any registry study data collection are conducted. If applicable, parents or legally authorized representatives must give signed informed consent.\n\nExclusion Criteria :\n\n* Currently participating in a palovarotene clinical trial;\n* Currently participating in any interventional clinical trial for FOP;\n* Have any contraindication to palovarotene as per the locally approved label (except for pregnant women who have previously received and discontinued palovarotene at any time during the pregnancy and who will be included for safety follow-up).","ALL","8 Years",{"count":90,"type":91},100,"ESTIMATED","OBSERVATIONAL","The participants in this registry study will have fibrodysplasia ossificans progressiva (FOP).\n\nFOP is an ultra-rare, severely disabling disease characterized by new bone formation in areas of the body where bone is not normally present (heterotopic ossification (HO)).\n\nHO is often preceded by painful, recurrent episodes of soft tissue swelling (flare-ups).\n\nThis registry study will take place in countries where the treatment, known as palovarotene, has been approved for use. Participants will either be treated with palovarotene (i.e already be receiving palovarotene as prescribed by their treating physician according to locally approved product information) or untreated with palovarotene.\n\nThe main aim of this registry study will be to collect and assess real-world safety data on children and adult participants with FOP treated with palovarotene.\n\nThis registry study will also describe the effectiveness of palovarotene in exposed participants, including the effect on everyday activities and physical performance.\n\nIn addition, this registry study aims to descriptively compare key safety outcomes (i.e. flare-up episodes, growth outcomes, and bone fractures) between participants exposed and unexposed to palovarotene.",[95],"Fibrodysplasia Ossificans Progressiva","2026-07-01",{"date":98,"type":99},"2026-07-02","ACTUAL",{"date":101,"type":99},"2024-12-05",{"date":103,"type":91},"2035-12-05",{"name":5,"class":6},5]