[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638897":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":45,"collaborators":19,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":19,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Gliknik Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GL-2045","EXPERIMENTAL","Participants will receive GL-2045 by SC injection during the treatment period.\n\nCohort 1: Adaptive design cohort during which dose adjustment may occur. Up to 18 participants will be enrolled\n\nCohort 2: Fixed-dose and dosing frequency testing 1 or 2 dose levels and dose regimens. Up to 24 participants will be enrolled",[13],"Drug: GL-2045",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Administrative route: SC injection",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Jim Bush, MBChB, PhD","Fortrea Clinical Research Unit Ltd.","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":19,"email":30},"Gliknik Clinical Trials Group","CONTACT","410-665-0662","gliknikclinicaltrialinquiries@gliknik.com",[32],{"facility":33,"status":34,"city":35,"state":19,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":19},"Fortrea Clinical Research Unit Ltd","RECRUITING","Leeds","LS11 9EH","United Kingdom","UK",{"type":40,"coordinates":41},"Point",[42,43],-1.54785,53.79648,{"lat":43,"lon":42},{"type":46,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100638897","phase-1-safety-and-efficacy-of-gl-2045-in-patients-with-immune-thrombocytopenia-100638897",false,"NCT07605845","Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia","Initial Safety and Efficacy, Sequential Group, Adaptive Dose Study of GL-2045 Subcutaneous Injection Repeat Doses in Patients With Immune Thrombocytopenia","Key Inclusion Criteria:\n\n1. Male or female between 18 and 80 years of age with ITP or certain limited ITP conditions.\n2. Females must not be pregnant or lactating. Males and females of childbearing potential must agree to use contraception.\n3. A platelet count of 10 to 49 × 10\\^9\u002FL at baseline.\n4. Study subjects must have prior response to corticosteroids or to intravenous immunoglobin (IVIg) documented by a consultant hematologist. Prior response to thrombopoietin receptor agonists is insufficient for eligibility.\n5. The subject may be on a stable dose of corticosteroids for the 3 months prior to study entry, limited to a daily dose of prednisone 10 mg or equivalent. No reductions or increases of steroids are allowed during the study.\n\nKey Exclusion Criteria:\n\n1. Any serious adverse event (SAE) with prior IVIg dosing.\n2. Prior splenectomy within 1 year of randomization or planned splenectomy during the study period.\n3. Participants with grade 2 bleeding by World Health Organization (WHO) bleeding criteria in the 8 weeks prior to treatment.\n4. Abnormal organ function including liver and kidney.\n5. Any previous or current treatments prohibited by the protocol.\n6. Treatment within the last 4 weeks or intention to treat during the study with a thrombopoietin receptor agonist including romiplostim (Nplate®), eltrombopag (Revolade®), or avatrombopag (Doptelet®).","ALL","18 Years","80 Years",{"count":58,"type":59},42,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).",[65],"Immune Thrombocytopenia",[67],"Adult ITP","2026-05-18",{"date":70,"type":71},"2026-05-26","ACTUAL",{"date":73,"type":71},"2026-04-14",{"date":75,"type":59},"2027-12-06",{"name":5,"class":6},1]