[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659312":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":11,"studyPopulation":11,"armGroups":34,"interventions":41,"overallOfficials":11,"centralContacts":46,"locations":11,"responsibleParty":52,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":11,"overallStatus":73,"whyStopped":11,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":11},{"fullName":5,"class":6},"Tectonic Operating Company, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of adverse events (AEs), including serious adverse events (SAEs)",null,"Screening up to Day 225",{"measure":14,"description":11,"timeFrame":15},"Incidence of clinically significant changes from baseline in safety laboratory assessments and other safety assessments","Baseline up to Day 225",[17,20,23,25],{"measure":18,"description":11,"timeFrame":19},"To assess hematologic support score change from baseline calculated over the 12 weeks preceding the time point","Baseline up to 6 months",{"measure":21,"description":11,"timeFrame":22},"To assess hematologic impact score","Measured at 6 months",{"measure":24,"description":11,"timeFrame":19},"To assess hemoglobin change from baseline",{"measure":26,"description":11,"timeFrame":27},"Change from baseline in the following calculated over the 12 weeks preceding the time point: - Total parenteral iron (mg) infused - Number of pRBCs transfused","Baselineup to 6 months",{"allocation":29,"interventionModel":30,"interventionModelDescription":11,"primaryPurpose":31,"observationalModel":11,"timePerspective":11,"maskingInfo":32},"NA","SINGLE_GROUP","TREATMENT",{"masking":33,"maskingDescription":11,"whoMasked":11},"NONE",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"TX002100","EXPERIMENTAL","Participants will receive subcutaneous (SC) injection of TX002100 administered weekly.",[40],"Biological: TX002100",[42],{"type":43,"name":36,"description":44,"armGroupLabels":45,"otherNames":11},"BIOLOGICAL","Subcutaneous injection",[36],[47],{"name":48,"role":49,"phone":50,"phoneExt":11,"email":51},"Clinical Trials","CONTACT","+1 339 337 4053","ClinicalTrials@tectonictx.com",{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659312","phase-1-phase-1b-study-of-tx002100-in-participants-with-hematologic-support-dependent-hereditary-hemorrhagic-telangiectasia-hht-100659312",false,"NCT07863609","Phase 1b Study of TX002100 in Participants With Hematologic Support-Dependent Hereditary Hemorrhagic Telangiectasia (HHT)","An Open-label, Phase 1b Study to Assess the Safety, Tolerability, and Efficacy of TX002100 in Participants With Hematologic Support-Dependent Hereditary Hemorrhagic Telangiectasia (HHT)","Inclusion Criteria:\n\n1. Adults with HHT who need regular intravenous iron or blood transfusions.\n2. Females of childbearing potential and male participants must agree to comply with the contraception requirements.\n3. Able to understand and is willing and able to comply with the study requirements and study procedures and agrees to participate in the study by giving written informed consent.\n\nExclusion Criteria:\n\n1. History of anemia of any cause other than HHT-related bleeding, or any other clinically significant inherited bleeding disorder aside from HHT.\n2. Has undergone or is anticipated to undergo liver transplantation.\n3. Medical conditions or comorbidities that, in the opinion of the investigator, would interfere with study compliance or data interpretation; or, in the opinion of the Investigator, taking part in the study would jeopardize the safety of the patient.\n4. History of hemorrhage from untreated pulmonary arteriovenous malformations (AVMs) manifesting as hemoptysis or hemothorax within 12 weeks before screening.\n5. Receipt of any vaccination within 2 weeks prior to first dose.\n6. Recent major surgery (within 4 weeks before the screening visit) or planned major surgery during the study.\n7. GI bleeding due to non-HHT disease (e.g., GI ulcers, diverticulosis), in the opinion of the investigator, within 6 months before screening.","ALL","18 Years","80 Years",{"count":65,"type":66},20,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","The primary purpose of this study is to assess the safety and tolerability of TX002100 in participants with hereditary hemorrhagic telangiectasia (HHT). The study will also look at whether TX002100 reduces the need for blood or iron treatments, and whether it improves blood counts, such as hemoglobin levels.",[72],"Hereditary Hemorrhagic Telangiectasia (HHT)","NOT_YET_RECRUITING","2026-10-02",{"date":76,"type":77},"2026-10-07","ACTUAL",{"date":79,"type":66},"2027-01-31",{"date":81,"type":66},"2028-12-31",{"name":5,"class":6}]