[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cavernous-malformations\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cavernous-malformations":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":21,"type":22},75,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Cavernous Malformations","Intracerebral Hemorrhage","Brainstem Stroke",[28,32,33,34],"Brainstem","Rebleeding rate","Sirolimus","RECRUITING","2024-12-17",{"date":38,"type":39},"2024-12-20","ACTUAL",{"date":41,"type":39},"2024-01-05",{"date":43,"type":22},"2026-12-31",{"name":45,"class":46},"Huashan Hospital","OTHER",2]