[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614639":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":31,"responsibleParty":38,"collaborators":31,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":31,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":74,"whyStopped":31,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":31},{"fullName":5,"class":6},"Biossil Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Senicapoc (SIL-8301)","EXPERIMENTAL","20 mg twice daily for 4 days, followed by 10 mg once daily for up to 24 weeks",[13],"Drug: Senicapoc",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Matching placebo tablets twice daily for 4 days, followed by once daily for up to 24 weeks",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Senicapoc","10 mg tablets; administered at a loading dose of 20 mg twice daily for 4 days, followed by a maintenance dose of 10 mg once daily for up to 24 weeks",[9],[27],"SIL-8301",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Tablets similar in size and color; matching administration schedule",[15],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Head of Regulatory and Operations","CONTACT","978-245-7397","debora@biossil.ai",{"type":39,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100614639","phase-2-efficacy-and-safety-of-sil-8301-for-control-of-hemolysis-in-a-uniform-sickle-cell-disease-endotype-100614639",false,"NCT07282210","Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype","A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Determine Efficacy and Safety of SIL-8301 in Sickle Cell Disease (SCD) Patients With a Predominantly Hemolytic Phenotype","RESCUE","Inclusion Criteria:\n\n* Documented diagnosis of sickle cell disease\n* 16-35 years of age\n* Hb ≤ 9.0 g\u002FdL\n* History of no more than 1 acute SCD-related painful crises requiring a visit to a medical facility per year within the preceding 2 years\n* History of at least one hemolytic complication\n* Current treatment with hydroxyurea\n\nExclusion Criteria:\n\n* Receipt of senicapoc in a previous investigational study\n* Current Red Blood Cell (RBC) transfusion or exchange transfusion program\n* History of pulmonary hypertension\n* Active cardiovascular, neurologic, endocrine, hepatic, or renal disorders\n* Diagnosis of cancer (except non-melanoma skin cancer in situ, cervical cancer in situ, or breast cancer in situ) within the last 5 years\n* History of liver disease","ALL","16 Years","35 Years",{"count":52,"type":53},105,"ESTIMATED","INTERVENTIONAL",[56],"PHASE2","SIL-8301 (senicapoc) is being developed for the chronic treatment of patients with sickle cell disease in both adults and children. The purpose of this study is to compare the effects of senicapoc to placebo in patients with sickle cell disease that have had fewer than 2 acute sickle-related painful crises per year over the preceding 2 years, and have a predominantly hemolytic phenotype, defined as presence or history of at least one hemolytic complication and a baseline Hb of 9 g\u002FdL or less, despite receiving hydroxyurea (an oral drug used for treatment of sickle cell disease) as standard of care. Participants will take senicapoc or matching placebo daily and continue on hydroxyurea as prescribed for up to 24 weeks.",[59,60,61],"Sickle Cell Disease","Sickle Cell Anaemia","Sickle Cell Anemia",[63,64,65,66,67,68,69,70,71,72,73],"senicapoc","Anemia, Hemolytic, Congenital","Anemia, Hemolytic","Anemia","Hematologic Diseases","Hemic and Lymphatic Diseases","Hemoglobinopathies","Genetic Diseases, Inborn","Congenital, Hereditary, and Neonatal Diseases and Abnormalities","Anemia, Sickle Cell","Anaemia, Sickle Cell","NOT_YET_RECRUITING","2025-12-01",{"date":77,"type":78},"2025-12-15","ACTUAL",{"date":80,"type":53},"2026-01",{"date":82,"type":53},"2029-01",{"name":5,"class":6}]