[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572871":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":30,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":11,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":11,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":57,"whyStopped":11,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":11},{"fullName":5,"class":6},"SK Plasma Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Prophylactic treatment","EXPERIMENTAL",null,[13],"Biological: SKP-0141",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","SKP-0141","Human plasma-derived coagulation factor VIII concentrate",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Byung Nam Chung","CONTACT","82-2-2008-2567","byung-nam.chung@sk.com",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Garam Kim, M.S.","+82-2-2008-2062","kgram@sk.com",{"type":31,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100572871","phase-3-an-open-label-study-evaluating-the-efficacy-safety-pharmacokinetics-and-immunogenicity-of-skp-0141-for-the-treatment-and-prophylaxis-in-severe-hemophilia-a-patients-100572871",false,"NCT06738901","An Open-label Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of SKP-0141 for the Treatment and Prophylaxis in Severe Hemophilia a Patients","A Phase 1\u002F3, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Human Plasma-derived Factor VIII (SKP-0141) for the Treatment and Prophylaxis in Male Patients with Severe Hemophilia a","Inclusion Criteria:\n\n* A patient or parent\u002Flegal guardian who is capable of giving signed informed consent\n* Patients assigned male at birth and must be 12 to 65 years old at the time of Screening\n* Diagnosis of severe congenital hemophilia A, defined as an FVIII level of \\\u003C1% as documented in the patient's medical records at the time of Screening\n* Patients who have received or are currently receiving plasma-derived and\u002For recombinant FVIII products and have had at least 150 EDs with a FVIII product\n* Patients who can produce viable sperm and have a partner of childbearing potential must agree to take appropriate contraceptive measures consistently during the study, starting at Screening and until 30 days after the end of study\n\nExclusion Criteria:\n\n* Any history of or current FVIII inhibitors or any first order family history of FVIII inhibitors in terms of detectable FVIII inhibitors (ie, ≥0.6 Bethesda Units \\[BU\\]) using the Nijmegen-modification of the Bethesda assay\n* Any known congenital or acquired coagulation disorder other than the congenital hemophilia A\n* Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction, and arterial embolus within 3 months prior to Visit 1\n* Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to Visit 1\n* Has been tested positive for HIV with a CD4+ count ≤200\u002FμL at Screening (if available, hepatitis B surface antigen, or hepatitis C virus antibodies, and\u002For positive hepatitis B virus deoxyribonucleic acid\u002FHCV ribonucleic acid at Screening\n* Platelet count \\\u003C100 000\u002FμL at Screening\n* Patients with serum aspartate aminotransferase or serum alanine aminotransferase values \\>5 × the upper limit of normal or serum creatinine values \\>2 × ULN at Screening\n* Patients who are currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment within 3 months prior to Visit 1\n* Use of any other investigational medicinal product, cryoprecipitate, whole blood, or plasma within 30 days or 5 half-lives prior to Visit 1\n* Known or suspected hypersensitivity to any FVIII product or their excipients\n* Has a physical, medical, or psychological condition, that in the opinion of the PI, may interfere with the evaluation of the study.\n* Are study site personnel directly affiliated with this study and their immediate families","MALE","12 Years","65 Years",{"count":43,"type":44},55,"ESTIMATED","INTERVENTIONAL",[47],"PHASE3","This is a prospective, multicenter, open-label study to assess efficacy, safety, pharmacokinetics (PK), and immunogenicity of human plasma-derived Factor VIII (FVIII) in previously treated patients (PTPs) with severe hemophilia A. Overall, 55 male PTPs aged 12 to 65 years old with a FVIII level of \\\u003C 1% and at least 150 treatment exposure days (EDs) with a previous FVIII product will be enrolled. Patients will receive SKP-0141 at a dose of 25 to 50 IU\u002Fkg every second day or 3 times per week for at least 50 EDs and\u002For 6 months from the start of prophylactic treatment. Efficacy of SKP-0141 will be primarily evaluated in bleeding prophylaxis with annualized bleeding rate from start of treatment and until end of treatment (Visit 10).",[50],"Hemophilia A, Severe",[52,53,54,55,56],"Congenital hemophilia A","Prophylaxis","On-demand","FVIII concentrate","Hemophilia A","NOT_YET_RECRUITING","2024-12-13",{"date":60,"type":61},"2024-12-18","ACTUAL",{"date":63,"type":44},"2025-03-31",{"date":65,"type":44},"2026-08-31",{"name":5,"class":6}]