[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523108":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":41,"locations":49,"responsibleParty":73,"collaborators":36,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":36,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":65,"whyStopped":36,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Huashan Hospital","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"High-dose sirolimus group","EXPERIMENTAL","Participants will receive oral sirolimus with a target blood concentration of 9-15ng\u002Fml continuously for 12 months.",[13],"Drug: Sirolimus",{"label":15,"type":10,"description":16,"interventionNames":17},"Low-dose sirolimus group","Participants will receive oral sirolimus with a target blood concentration of 3-7ng\u002Fml continuously for 12 months",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo control group","PLACEBO_COMPARATOR","Participants will receive oral placebo(starch formulation) for 12 months.",[23],"Drug: Starch flake",[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Sirolimus","Sirolimus is an mTORC1 inhibitor that has received approval from the U.S. Food and Drug Administration (FDA) and has recently been successfully used to treat lymphatic malformations and venous\u002Flymphatic malformations associated with the same PIK3CA GOF mutations.",[9,15],[31],"Rapamycin",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Starch flake","The placebo is composed of starch material and is formulated at 0.5 grams per tablet.",[19],null,[38],{"name":39,"affiliation":5,"role":40},"Wei Zhu, Doctor","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":36,"email":46},"Zongze Li, Doctor","CONTACT","+8613121226581","lizongze666@aliyun.com",{"name":39,"role":44,"phone":45,"phoneExt":36,"email":48},"drzhuwei@fudan.edu.cn",[50,64],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":36},"Huashan Hospital, Fudan University","ACTIVE_NOT_RECRUITING","Shanghai","Shanghai Municipality","200040","China","CN",{"type":59,"coordinates":60},"Point",[61,62],121.45806,31.22222,{"lat":62,"lon":61},{"facility":51,"status":65,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"RECRUITING",{"type":59,"coordinates":67},[61,62],{"lat":62,"lon":61},[70],{"name":39,"role":44,"phone":71,"phoneExt":72,"email":46},"+86 021 52887718","+86 1312122658",{"type":40,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Wei Zhu","Vice director of neurosurgey department","100523108","phase-2-hemorrhagic-brainstem-cavernous-malformations-treatment-with-sirolimus-asingle-centre-randomized-placebo-controlled-pilot-trial-100523108",false,"NCT06091332","Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: aSingle Centre, Randomized, Placebo-controlled Pilot Trial","Hemorrhagic Brainstem Cavernous Malformations Treatment With Sirolimus: a Randomized, Placebo-controlled Pilot Trial","CALM","Inclusion Criteria:\n\n1. Age 18-65 years, any gender;\n2. Patients who have experienced their first symptomatic BSCM ICH within the six months before randomisation;\n3. Diagnosed with solitary BSCM through T2, GRE\u002FT2\\*, or SWI MR imaging;\n4. ICH within or around the BSCM confirmed by CT \u002FMR;\n5. Capable of signing an informed consent form with the accompaniment and understanding of a guardian.\n\nExclusion Criteria:\n\n1. Cancer history;\n2. Pregnancy or lactation;\n3. Sirolimus\u002Fstarch allergy;\n4. Modified Rankin Scale (mRS) score 5, respiratory failure or currently severe bleeding requiring life support treatment;\n5. Abnormal liver and\u002For kidney function (transaminase levels greater than 50, creatinine greater than 110), abnormal white blood cell\u002Fplatelet counts (white blood cell count below 3.5 or above 9.5 x 109\u002FL or exceeding normal values, platelet count below 100 or above 300);\n6. History of previous immunosuppressive therapy;\n7. History of prior surgical intervention for CCM ;\n8. History of prior cranial radiation therapy ;\n9. Familial CCM or people with multiple CCM;\n10. Patients with concurrent acute active infections (e.g., severe bacterial, viral, or fungal infections);\n11. Uncontrolled diabetes mellitus;\n12. Currently participating in another clinical trial;\n13. Patient unwilling\u002Funable to undergo MRI.\n14. Co-administration of drugs affecting CYP3A4 enzymes (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin).","ALL","18 Years","65 Years",{"count":88,"type":89},75,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","The aim of this pilot phase trial is to assess the safety and tolerability, and estimate the efficacy of sirolimus in reducing the incidence of ICH during high-risk periods for rebleeding, compared to placebo. This pilot trial will inform the design of a future definitive clinical trial on sirolimus treatment for CCM.",[95,96,97],"Cavernous Malformations","Intracerebral Hemorrhage","Brainstem Stroke",[95,99,100,27],"Brainstem","Rebleeding rate","2024-12-17",{"date":103,"type":104},"2024-12-20","ACTUAL",{"date":106,"type":104},"2024-01-05",{"date":108,"type":89},"2026-12-31",{"name":5,"class":6},2]