[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ace-inhibitor-induced-angioedema\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ace-inhibitor-induced-angioedema":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100532276","angioedema-biomarker-research-study-100532276",false,"NCT06210698","Angioedema Biomarker Research Study","Inclusion Criteria:\n\n* Understand and sign the informed consent form before starting any study procedure.\n* Adult or Child: aged 12 years of age or older (consent must be signed by a single parent or legal guardian).\n* Angioedema symptoms and signs by medical history, or previous laboratory diagnostic testing, or genetically proven cases (e.g. SERPING1 or other mutation). Patients can be on active medication for the treatment and prophylaxis of angioedema. Angioedema cases must be verified by a clinician from IAA.\n* Able to perform and endure safely the collection of peripheral blood samples (venipuncture), or optionally agree to have additional testing via a skin punch biopsy.\n\nExclusion Criteria:\n\n* Minor: 11 years of age or younger.\n* Cannot read or understand the informed consent form and instructions.\n* Unable to perform the peripheral blood sample collection.\n* Taking medications contraindicated for testing.\n* History of excessive bleeding after phlebotomy, e.g. Hemophilia.\n* Contraindication due to other health-related issues.",true,"ALL","12 Years","75 Years",{"count":20,"type":21},600,"ESTIMATED","OBSERVATIONAL","This clinical trial aims to evaluate and compare novel and commercially available diagnostic assays through blood tests for the differential diagnosis and comprehensive assessment of patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. The primary objective is to assess the efficiency of novel diagnostic assays, both individually and in combination, in comparison to currently available commercial tests. The ultimate goal is to establish the feasibility of developing an affordable and accurate laboratory test capable of diagnosing the diverse etiological manifestations of angioedema.",[25,26,27,28,29,30,31,32],"Angioedema","Angioedemas, Hereditary","Urticaria","Mastocytosis","ACE Inhibitor-Induced Angioedema","C1 Inhibitor Deficiency","Systemic Mastocytoses","Indolent Systemic Mastocytosis",[34,35,36,37,38,39,40,41,42,43],"angioedema","c1-inhibitor deficiency","C1-inhibitor dysfunction","hereditary angioedema","HAE","ACE Inhibitor-induced angioedema","serum tryptase","mastocytosis","systemic mastocytosis","indolent systemic mastocytosis","RECRUITING","2026-08-20",{"date":47,"type":48},"2026-08-24","ACTUAL",{"date":50,"type":48},"2024-01-15",{"date":52,"type":21},"2027-08-01",{"name":54,"class":55},"Foundation For Rare Disease Research","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":4},"100568300","phase-3-safety-and-efficacy-of-conestat-alfa-for-ace-induced-angioedema-100568300","NCT06679426","Safety and Efficacy of Conestat Alfa for ACE-Induced Angioedema","A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study Evaluating the Safety and Efficacy of Conestat Alfa As a Treatment for Angiotensin-Converting Enzyme-Inhibitor-Induced Angioedema","Inclusion Criteria:\n\n1\\. Age 18 years or older 2. Currently being treated with an ACE-I and presenting with presumed ACE-I-induced AE involving the head and\u002For neck region as determined by the clinical team 3. ACE-I-induced AE of the head and\u002For neck region of at least moderate severity within 24 hours of onset (must be sufficiently less than 24 hours to allow study drug to be administered within the same time frame) 4. AE that is at least moderate in severity for no less than one of the AE-associated airway symptoms (difficulty breathing, difficulty swallowing, voice changes, tongue swelling)32 5. Be able to provide informed consent or obtain informed consent from a legally appointed representative\n\n\\-\n\nExclusion Criteria:\n\n1\\. History of anaphylaxis, hypersensitivity, or allergic reactions to rabbits\u002Frabbit-derived products and C1-INH preparations 2. Urticaria present during the current illness 3. AE thought by the clinical team to be due to any other etiology i.e., HAE (types I, II, and HAE with normal C1-INH), acquired AE, allergic\u002Fhistaminergic AE 4. History of recent trauma, abscess, infection, local inflammation, local tumor, postoperative or post-radiogenic edema, salivary gland disorders, and non-ACE-I drug-induced AE 5. Family history of recurrent AE 6. History of AE prior to ACE-I therapy initiation 7. Last dose of ACE-I taken more than 72 hours before the onset of AE symptoms 8. History of a major systemic disease that is not well controlled (left to the study team's discretion) 9. Anyone requiring immediate airway intervention according to the clinical team, such as endotracheal intubation 10. Women who are pregnant or breast-feeding (pregnancy must be ruled out by a negative test with the exception of those who have undergone total hysterectomy, bilateral oophorectomy, or are 2 years post-menopausal) 11. Concurrent participation in other investigational drug studies 12. Treatment with other targeted therapeutic agents for HAE (ecallantide\u002Ficatibant\u002FC1-INH\u002Ffresh frozen plasma) 13. In the opinion of the investigator, there is adequate response to the usual care treatments (epinephrine, H1 and\u002For H2 antihistamine, corticosteroids) within one hour before dosing of the study drug 14. Prisoners 15. Non-English speaking\n\n\\-","18 Years",{"count":66,"type":21},24,"INTERVENTIONAL",[69],"PHASE3","Angiotensin-converting enzyme inhibitors (ACE-Is), prescribed most often to treat hypertension, have been used extensively since the 1980s. Additional indications for their use include heart failure, diabetes mellitus, chronic kidney disease, and post-myocardial infarction. It is estimated that up to 40 million patients take ACE-Is worldwide. C1-INH is a serine protease inhibitor that is normally found in the blood. Its primary function is the regulation of the complement and contact system pathways by binding irreversibly to target proteases. It additionally inhibits the fibrinolytic, clotting, and kinin pathways.31 Patients with the hereditary forms of AE (HAE) tend to have lower quantitative or functional levels of C1-INH. This results in decreased suppression of plasma kallikrein and factor XIIa leading to cleavage of high molecular weight kininogen to form increased circulating levels of bradykinin. Bradykinin binds to bradykinin 2 receptors resulting in separation of endothelial vascular cells and extravasation of fluid manifesting clinically as angioedema. Conestat alfa (Ruconest®) is a recombinant human C1-INH that has been purified from the breast milk of genetically modified rabbits. It is a single-chain soluble glycoprotein that is made of 478 amino acids. Administering conestat alfa increases the amount of C1-INH in these patients, repleting their levels, and acting as a treatment for AE due to C1-INH deficiency. Conestat alfa has been studied on asymptomatic patients with HAE and was shown to dose-dependently increase the level of functional C1-INH. Additionally, it was shown to restore the level of the complement C4 protein, which is also decreased in these patients. Since the same pathophysiological pathway is involved in patients with ACE-I-induced AE, it is reasonable to hypothesize its effectiveness in the treatment of patients with acute attacks.",[29],[73],"Ruconest, conestat alpha, ACE inhibitor, angioedema, treatment, outcome, safety","NOT_YET_RECRUITING","2024-11-05",{"date":77,"type":48},"2024-11-07",{"date":79,"type":21},"2024-12-01",{"date":81,"type":21},"2025-12",{"name":83,"class":55},"University of Cincinnati","ACE Inhibitor Induced Angioedema"]