[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603464":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":47,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":30,"maxAge":30,"enrollmentInfo":63,"targetDuration":30,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":35,"whyStopped":30,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Emory University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Eptacog beta","EXPERIMENTAL","For the initial 3 months, participants will be in a non-interventional phase and receive standard-of-care on-demand therapy for acute bleeding at their hematologist's discretion. Following this non-interventional phase, they will use eptacog beta on-demand to treat acute bleeding for 6 months. Throughout the study, they will log bleeding events and management in a diary. Hemostatic efficacy after treatment will be assessed using a 4-point hemostasis efficacy scale.\n\nParticipants will have the option to re-consent for an exploratory phase, adding 6 months to their time on the study (total of 15 months). For those entering the optional extension phase, eptacog beta will be routinely administered for bleed prophylaxis. The treating hematologist will determine the best method\u002Flocation for infusions. The number of bleeding events over time will be compared between the prophylaxis phase and the on-demand phase.",[13],"Drug: EPTACOG BETA",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","EPTACOG BETA","Eptacog beta (SEVENFACT®; EB) is a lyophilized powder in single-use vials (1, 2, or 5 mg) of coagulation factor VIIa (recombinant)-jncw. It is reconstituted with sterile water (provided in the kit) and administered intravenously.\n\nSEVENFACT® may be administered by a healthcare provider (HCP) at the study site or home, or by a trained participant\u002Fcaregiver. Participants will be monitored in a healthcare facility for 60 minutes after the first dose for hypersensitivity.",[9],[21],"SEVENTFACT®; EB",[23],{"name":24,"affiliation":5,"role":25},"Karen Zimowski, MD","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","404-785-1200",null,"kzimows@emory.edu",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":30},"Arthur M. Blank Hospital | Children's Healthcare of Atlanta","RECRUITING","Atlanta","Georgia","30329","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-84.38798,33.749,{"lat":45,"lon":44},{"type":25,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Karen L. Zimowski","Assistant Professor",[51],{"name":52,"class":53},"Laboratoire français de Fractionnement et de Biotechnologies","INDUSTRY","100603464","phase-2-eptacog-beta-in-glanzmanns-hetlfb-strength-studyfid531-100603464",false,"NCT07136857","Eptacog Beta in Glanzmann's (HeT_LFB-Strength-Study_FID531)","Study To Assess Response to Eptacog Beta iN Patients With Glanzmann THromboasthenia (STRENGTH )","STRENGTH","Inclusion Criteria:\n\n* Adult or Pediatric persons with inherited Glanzmann thrombasthenia (see diagnostic criteria below)\n* Severe bleeding phenotype\n* Adequate hepatic function\n* Adequate renal function\n* Adults subject (≥18 years of age) or caregiver (parent or legally authorized representative) for minor subjects, subjects with cognitive impairment, or subjects with impaired decision-making capacity have provided written informed consent, and the participant has given consent\u002Fassent (if applicable)\n* Ability to speak, read, and understand the English language\n\nExclusion Criteria:\n\n* Thrombocytopenia (platelet count \\\u003C 100k)\n* Acquired Glanzmann thrombasthenia secondary to autoimmune disease, malignancy, or medication\n* Inherited or acquired bleeding diathesis other than Glanzmann thrombasthenia\n* Have a history of venous or arterial thrombotic event within 2 years of study enrollment\n* Active malignancy\n* Known or suspected hypersensitivity to rabbits, rabbit protein, other forms of rFVIIa, or to any of the EB excipients\n* Have received an investigational drug within 30 days or within 5 half-lives of that investigational drug (whichever is longer) or are expected to receive such a drug during participation in this study\n* Be using aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), herbs, natural medications, or other drugs with platelet inhibitor properties for the duration of the study\n* Be using or administered anticoagulant agents for the duration of the study\n* Have any life-threatening disease or other disease or condition which, according to the investigator's judgement, could imply a potential hazard to the patient, or interfere with the study participation or study outcome\n* Use of systemic immunomodulators at enrollment or planned use during the study","ALL",{"count":64,"type":65},6,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","This study is evaluating an investigational drug, eptacog beta (EB), for the treatment and prevention of acute bleeding episodes in people with Glanzmann Thrombasthenia, a rare inherited bleeding disorder. Eptacog beta (EB) is not currently approved by the U.S. Food and Drug Administration (FDA) for this condition.\n\nThe study will assess the effectiveness and safety of eptacog beta (EB) when used to treat serious bleeding events, and in an optional phase, when used routinely to prevent bleeding. During the first three (3) months, participants will manage any bleeding episodes with their standard treatment (e.g., factor products or platelet transfusions). After this initial period, they will use the study drug to treat serious bleeding events.\n\nParticipants will have approximately 4 to 5 visits with their hematologist over the 9-month study period. They will also be asked to complete a diary documenting bleeding episodes and treatments, and to answer questions about how bleeding affects their daily life. Blood samples will be collected to monitor their condition and any potential side effects of the study drug.\n\nAt the end of the main study, participants will have the option to enter an optional extension phase, where they will receive routine intravenous infusions of the study drug 2 to 3 times per week for 6 months to help prevent future bleeding episodes and complications.",[71],"Glanzmann Thrombasthenia",[73,74,75],"Severe Bleeding","Prevention of Bleeding","Eptacog beta (EB)","2025-11-24",{"date":78,"type":79},"2025-12-01","ACTUAL",{"date":81,"type":79},"2025-10-02",{"date":83,"type":65},"2026-12",{"name":5,"class":6},1]