[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470111":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":84,"collaborators":26,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":26,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Intervention: Canakinumab","ACTIVE_COMPARATOR","Standard dose of canakinumab (Ilaris®; Novartis Switzerland), i. e. 150 mg subcutaneously.\n\nCanakinumab (Ilaris®, Novartis) is a recombinant, human monoclonal IgG1\u002Fkappa antibody inhibiting IL-1β by neutralizing its biological activity through binding to the IL-1 receptor.",[13],"Drug: Canakinumab",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Intervention: Placebo (0.9% NaCl)","PLACEBO_COMPARATOR","Placebo: 1 ml of 0.9 % NaCl",[19],"Drug: Placebo (0.9% NaCl)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Canakinumab","Canakinumab (Ilaris®, Novartis Switzerland) will be used in the recommended standard dose of 150 mg subcutaneously once. Patients will be randomized at visit 2 = Baseline to either placebo (1 ml 0.9 % saline solution s.c.) or treatment with 1 ml 150 mg canakinumab solution s.c. in a 1:1 manner.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo (0.9% NaCl)","1 ml 0.9 % saline solution s.c. Patients will be randomized at visit 2 = Baseline to either placebo (1 ml 0.9 % saline solution s.c.) or treatment with 1 ml 150 mg canakinumab solution s.c. in a 1:1 manner.",[15],[32],{"name":33,"affiliation":34,"role":35},"Marc Y Donath, Prof. Dr.","University of Basel","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+41 61 265 25 25","marc.donath@usb.ch",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Susanne Ruesch","+41 61 556 5655","susanne.ruesch@usb.ch",[46,69],{"facility":47,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University Hospital Basel, Division of Endocrinology, Diabetes and Metabolism","RECRUITING","Basel","4031","Switzerland","CH",{"type":54,"coordinates":55},"Point",[56,57],7.57327,47.55839,{"lat":57,"lon":56},[60,62,63,64,67],{"name":61,"role":38,"phone":39,"phoneExt":26,"email":40},"Marc Y Donath, Prof. Dr. med.",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":65,"role":66,"phone":26,"phoneExt":26,"email":26},"Justus Fischer","SUB_INVESTIGATOR",{"name":68,"role":35,"phone":26,"phoneExt":26,"email":26},"Matthias Hepprich, Dr.",{"facility":70,"status":48,"city":71,"state":26,"zip":72,"country":51,"countryCode":52,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Cantonal Hospital Olten, Division of Endocrinology","Olten","4600",{"type":54,"coordinates":74},[75,76],7.90329,47.34999,{"lat":76,"lon":75},[79,83],{"name":80,"role":38,"phone":81,"phoneExt":26,"email":82},"Matthias Hepprich, PD Dr.","+41 62 311 47 33","matthias.hepprich@spital.so.ch",{"name":80,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":85,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100470111","phase-3-canakinumab-for-the-treatment-of-postprandial-hypoglycemia-100470111",false,"NCT05401578","Canakinumab for the Treatment of Postprandial Hypoglycemia","Canakinumab for the Treatment of Postprandial Hypoglycemia - CanpHy Study","CanpHy","Inclusion Criteria:\n\n* Patients after bariatric surgery (i.e. sleeve gastrectomy, Roux-en-Y gastric bypass, omega-loop bypass, biliopancreatic diversion) with documented hypoglycemia, i. e. \\\u003C 3.0 mmol\u002Fl and at least 5 hypoglycemic episodes per week despite dietary modification\n* For women with child-bearing potential, willingness to use contraceptive measures adequate to prevent pregnancy during the study\n* Informed Consent as documented by signature\n\nExclusion Criteria:\n\n* Any type of diabetes mellitus according to ADA criteria\n* Intolerance to the study drug\n* Signs of current infection\n* Any use of immunosuppressive medication\n* Use of any drug therapy for postbariatric hypoglycemia apart from acarbose (all remaining drugs have to be discontinued four half-life times before screening phase)\n* Neutropenia (leukocyte count \\\u003C 1.5 × 109\u002FL or ANC \\\u003C 0.5 × 109\u002FL)\n* Anemia (hemoglobin \\\u003C 11 g\u002FdL for males, \\\u003C 10 g\u002FdL for females)\n* Clinically significant kidney or liver disease (creatinine \\> 1.5 mg\u002FdL, AST\u002FALT \\> 2 × ULN, alkaline phosphatase \\> 2 × ULN, or total bilirubin \\[tBili\\] \\> 1.5 × ULN)\n* Uncontrolled congestive heart failure\n* Uncontrolled malignant disease\n* Currently pregnant or breastfeeding\n* Known or suspected non-compliance, drug or alcohol abuse\n* Meeting the criteria for vulnerability (e.g. participants incapable of judgment or participants under tutelage)\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.\n* Participation in another clinical trial using investigational drugs in the last 30 days or planned participation in the next 60 days\n* Previous enrolment into the current study,\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons","ALL","18 Years","75 Years",{"count":98,"type":99},56,"ESTIMATED","INTERVENTIONAL",[102],"PHASE3","The primary objective of this randomized trial is to test whether a treatment with canakinumab is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.",[105],"Postprandial Hypoglycemia",[107,108,109,110,111],"bariatric surgery","IL-1 receptor antagonist","postbariatric hypoglycemia","canakinumab","quality of life","2025-01-27",{"date":114,"type":115},"2025-01-29","ACTUAL",{"date":117,"type":115},"2023-04-17",{"date":119,"type":99},"2026-05-31",{"name":5,"class":6},2]