[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hereditary-angioedema-hae\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hereditary-angioedema-hae":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,39,59,82,113,135,158,178,207,223,257],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100627165","a-study-of-takhzyro-in-teenagers-and-adults-with-hereditary-angioedema-hae-in-south-korea-100627165",false,"NCT07445087","A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea","A Post Marketing Surveillance Study (Usage Results Study) for Takhzyro in South Korea","Inclusion criteria:\n\n1. Participants aged 12 years or older at time of initiation of Takhzyro.\n2. Participants who are treated or will be treated with Takhzyro according to the approved label of South Korea.\n3. The participant or legally authorized representative agrees to participate.\n\nExclusion criteria:\n\n1. Any of the contraindications included in the Prescribing Information (PI) for TAKHZYRO apply.\n2. Participant is currently enrolled in an interventional trial.","ALL","12 Years",{"count":19,"type":20},35,"ESTIMATED","OBSERVATIONAL","Takhzyro is an approved treatment for hereditary angioedema (HAE) in South Korea. HAE is a rare condition which causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. The main aim of this study is to check how safe Takhzyro is in teenagers and adults with HAE in everyday medical care in South Korea. Another aim is to see how well Takhzyro works in everyday medical care.\n\nThe treatment of participants and any check-ups will be determined by the treating doctors according to their normal practice. Participants may visit the study clinic several times during the study.",[24],"Hereditary Angioedema (HAE)",[26],"Drug Therapy","NOT_YET_RECRUITING","2026-06-17",{"date":30,"type":31},"2026-06-18","ACTUAL",{"date":33,"type":20},"2026-10-01",{"date":35,"type":20},"2032-02-29",{"name":37,"class":38},"Takeda","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":58},"100609731","a-study-about-the-diagnosis-and-management-of-hereditary-angioedema-hae-in-egypt-100609731","NCT07218393","A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt","Retrospective and Prospective Real-World Evidence (RWE) Study Investigating Diagnosis and Therapeutic Management of Patients With HAE Type I or II in the Current Medical Practice in Egypt: the EXPLORHAE Study (EXPLORing Prospective and Retrospective Health Assessments of HAE in Egypt)","EXPLORHAE","Inclusion Criteria: Retrospective Phase:\n\n1. The participant has a confirmed HAE-C1INH type1 or type2 diagnosis in medical records (based on clinical history and\u002For laboratory diagnosis in medical records).\n2. The participant was diagnosed and\u002For treated from January 2015 to August 2025.\n\nInclusion Criteria: Prospective Phase:\n\n1. The participant has a physician-confirmed HAE-C1INH type1 or type2 diagnosis (based on clinical history and\u002For laboratory diagnosis).\n2. The participant signed an informed consent or assent.\n3. The participant should have had at least one visit to the treating physician\u002Finvestigator during enrollment and the follow-up period.\n4. The participant was not enrolled in the study's retrospective phase.\n\nExclusion Criteria: (For both retrospective and prospective phases):\n\n1. Participant with AAE-C1INH (acquired angioedema), drug-induced angioedema (AE-DI) (example angiotensin-converting enzyme inhibitors-I \\[ACE-I\\] angioedema), allergic mediated angioedema, inflammatory angioedema, or idiopathic angioedema.\n2. HAE participants with normal C1-INH (HAE-nC1INH).\n3. Participant deemed unsuitable for participation for any reason, based on the investigator's clinical judgment.","1 Year",{"count":49,"type":20},100,"Hereditary angioedema (HAE) is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels. HAE is classified based on the amount of a protein in the blood called C1 inhibitor (C1-INH): HAE with normal C1-INH levels and HAE with limited or insufficient C1-INH levels (C1-INH deficiency); HAE with C1-INH deficiency can be divided into Type1, with low levels of C1-INH, and Type 2, in which the protein is there, but does not work properly. This study will look at people with HAE Type1 or Type2.\n\nThe main aim of this study is to describe the diagnosis and management of people with HAE Type1 or HAE Type2 in Egypt. Other aims are to learn more about people with HAE Type1 or Type2, including, but not limited to, other conditions they may have, family history, impact of HAE on daily life, if treatment is stopped and the reasons.\n\nDuring the study, information from already existing data in a participant's medical record will be reviewed and new data will be collected during routine visits of a participant to the study clinic.",[24],{"date":30,"type":31},{"date":54,"type":20},"2026-12-01",{"date":56,"type":20},"2027-12-01",{"name":37,"class":38},7,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100612311","a-study-of-lanadelumab-in-children-with-hereditary-angioedema-hae-in-multiple-countries-100612311","NCT07251933","A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries","A Multi-national Real-world Outcomes and Treatment Patterns Study of Lanadelumab (Takhzyro) in Paediatric Patients With Hereditary Angioedema (TAHORA)","Inclusion Criteria:\n\n1. Participant is aged 2 to less than (\\\u003C) 12 years at the time of lanadelumab initiation and is expected to have at least 6 months of follow-up information before turning 12.\n2. Participant has physician-confirmed diagnosis of HAE-C1INH.\n3. Participant initiated LTP with lanadelumab during the eligibility period.\n4. Signed consent\u002Fassent (where required by local regulations).\n5. Participant's medical record contains documentation of HAE attacks in the pre-index period and after lanadelumab initiation.\n\nExclusion Criteria:\n\n1. Participant was enrolled in a therapeutic investigational drug (lanadelumab or other drug) or device trial at index date.\n2. Participant with no documented HAE attacks in the 12 months prior to index date.","2 Years","11 Years",{"count":69,"type":20},40,"HAE is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels but does not cause itching or hives. HAE is classified based on the amount of a protein in the blood called C1 inhibitor (C1-INH): HAE with normal C1-INH levels and HAE with limited or insufficient C1-INH levels (C1-INH deficiency). This study will concentrate on children with HAE C1-INH deficiency who have received Takhzyro (Lanadelumab) as prophylactic treatment.\n\nThe main goal of the study is to assess how well lanadelumab works in children with HAE-C1INH deficiency in everyday life. This will be measured by checking how long children who receive lanadelumab will be free of HAE attacks.\n\nOther goals are to understand how children with HAE-C1INH deficiency are being treated with lanadelumab, how well the treatment works for them, how safe it is and how often these children need to use healthcare services (like doctor visits, hospital stays, etc.) because of their condition.\n\nThe study will only look at data already existing in the participants' medical records. No treatment will be given as part of the study.",[24],[26],"RECRUITING","2026-06-16",{"date":30,"type":31},{"date":77,"type":31},"2026-02-05",{"date":79,"type":20},"2026-06-30",{"name":37,"class":38},24,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100625889","phase-3-phase-3-extension-study-of-adx-324-in-participants-with-hereditary-angioedema-hae-100625889","NCT07428499","Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)","A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema","Inclusion Criteria:\n\n* Have a documented diagnosis of HAE (Type I or II)\n* Completed Study ADX-324-301\n* Have access to an acute therapy to treat HAE attacks (such as plasma derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)\n\nExclusion Criteria:\n\n* A negative reaction to study drug in ADX-324-301","18 Years",{"count":91,"type":20},90,"INTERVENTIONAL",[94],"PHASE3","Study ADX-324-302 is an extension study for participants who complete the Phase 3 ADX-324-301 trial. The extension study will provide information about the safety and efficacy of additional dosing of ADX-324 in participants with Type I and Type II hereditary angioedema (HAE). The study will also include pharmacodynamic (PD), pharmacokinetic (PK), and health-related quality of life (HRQoL) measurements.",[24,97,98,99],"Hereditary Angioedema - Type 1","Hereditary Angioedema - Type 2","HAE",[101,99,102,103],"Hereditary angioedema","ADX-324","onvuzosiran","2026-06-12",{"date":74,"type":31},{"date":107,"type":31},"2026-04-02",{"date":109,"type":20},"2030-06-30",{"name":111,"class":38},"ADARx Pharmaceuticals, Inc.",48,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":66,"maxAge":67,"enrollmentInfo":120,"targetDuration":4,"studyType":92,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100615887","phase-3-donidalorsen-treatment-in-children-with-hereditary-angioedema-100615887","NCT07298447","Donidalorsen Treatment in Children With Hereditary Angioedema","An Open-Label Study of Donidalorsen in Pediatric Patients Age 2 to Less Than 12 Years Old With Hereditary Angioedema","Key Inclusion Criteria:\n\n1. Must be between the ages of 2 and less than 12 years, inclusive, at the time of informed consent and, as applicable, assent.\n2. Must weigh at least 9 kg at the time of informed consent and, as applicable, assent.\n3. Documented diagnosis of HAE-1\u002FHAE-2 based upon both of the following:\n\n   1. Documented clinical history consistent with HAE (SC or mucosal, non-pruritic swelling episodes without accompanying urticaria).\n   2. Diagnostic testing results that confirm HAE-1\u002FHAE-2: C1-inhibitor (C1-INH) functional level \\\u003C50% normal level AND complement factor C4 level below the lower limit of normal (LLN); OR a known pathogenic mutation in the SERPING1 gene.\n\nKey Exclusion Criteria:\n\n1. Must not have any screening laboratory abnormalities or any other clinically significant abnormalities during screening that would render a participant unsuitable for inclusion.\n2. Must not have been treated with another investigational drug, biological agent, or device within 1 month of Screening, or 5 half-lives of investigational agent, whichever is longer.\n3. Concurrent diagnosis of any other type of recurrent angioedema, including idiopathic angioedema or HAE with normal C1-INH (HAE-nC1-INH or Type III).\n\nNote: Other protocol-specified inclusion\u002Fexclusion criteria may apply.",{"count":121,"type":20},20,[94],"The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of donidalorsen in pediatric participants with hereditary angioedema (HAE) Type I (HAE-1) or Type II (HAE-2).",[24],"2026-05-27",{"date":127,"type":31},"2026-05-28",{"date":129,"type":31},"2026-04-21",{"date":131,"type":20},"2029-06",{"name":133,"class":38},"Ionis Pharmaceuticals, Inc.",10,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":92,"phases":145,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100615496","a-study-to-learn-about-the-c1-inhibitor-function-as-diagnosis-for-hereditary-angioedema-100615496","NCT07293364","A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema","A Prospective, Open- Label, Single-country (Algeria), Interventional Study to Assess Measurements of Functional C1-inhibitor Alone for Hereditary Angioedema Diagnosis: The AHAE Study","AHAE","Inclusion Criteria\n\n1. Adult and pediatric participants of both sexes (children over the age of 12 years).\n2. Participants providing a signed informed consent form (ICF), or parental consent for minors.\n3. Participants should also meet one of the 2 inclusion criteria below:\n\n   1. Participants with a high suspicion of bradykinin-mediated HAE, referred to the center. This includes recurrent episodes of nonpitting angioedema without urticaria or itching, lasting between 1 and 5 days, and non-responsive to antihistamine and corticosteroid treatments.\n   2. Family members (from 1st to 4th degree relatives) of known HAE participants.\n\nExclusion Criteria\n\n1. Confirmed diagnosis of HAE-C1INH-Type1 or HAE-C1INH-Type2.\n2. Angioedema with urticaria or itching (suggesting histaminergic etiology).\n3. Angioedema episodes lasting less than (\\\u003C)1 day or greater than (\\>)5 days (not consistent with bradykinin-mediated HAE).\n4. Any condition deemed unsuitable by the investigator that may interfere with study procedures or data integrity.",{"count":144,"type":20},514,[146],"NA","Hereditary angioedema (HAE) is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels but does not cause itching or hives. HAE is classified based on the amount of a protein in the blood called C1-inhibitor (C1INH): HAE with normal C1INH levels and function (HAE-nC1INH) and HAE with deficiency in C1INH levels (HAE-C1INH-Type1) or dysfunction (HAE-C1INH-Type2). This study will focus on the practical use and accuracy of measuring the C1INH function alone to diagnose HAE-C1INH-Type1 and HAE-C1INH-Type2 compared to the tests used in normal clinical practice in Algeria.\n\nThe main goal of the study is to see how well a test focusing on the C1INH function alone works to diagnose HAE-C1INH as compared to the tests used in normal clinical practice (standard of care or SoC) in Algeria. Another aim is to determine a reference value (helps in determining the accuracy) of the C1INH function test. This study will also help to find out how many people who are thought to have HAE or who have family members with HAE actually get diagnosed and to gather participants' health background information, such as their age when they were diagnosed, what signs and symptoms they had, how long it took to get diagnosed, and how they were sent to the doctors or specialists who treated them.\n\nDuring the study all participants will undergo two different methods of HAE testing: the test focusing on the C1INH function alone and the SoC tests. Test results will be confirmed via a second test run for newly index cases or for discordant results, but participants with a test result of \"no HAE\" and positive cases recruited through family screening will not undergo a second confirmatory test. In case of discordant test results in the second round, participants will undergo a third confirmatory test round. Participants can visit the clinic up to three times during the study. No further follow up is planned for participants, even for those who are diagnosed with HAE.",[24],"2026-05-15",{"date":151,"type":31},"2026-05-19",{"date":153,"type":31},"2026-05-12",{"date":155,"type":20},"2027-06-12",{"name":37,"class":38},1,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":157},"100613215","a-study-of-lanadelumab-in-teenagers-and-adults-with-hereditary-angioedema-hae-in-the-kingdom-of-saudi-arabia-100613215","NCT07263685","A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) in the Kingdom of Saudi Arabia","Retrospective Chart Review Study Evaluating Clinical Effectiveness and Impact on Quality of Life Among Patients Who Initiated Long-term Prophylaxis With Takhzyro® in a Real-World Setting in the Kingdom of Saudi Arabia - the REFLEQT-KSA Study (Retrospective Evaluation Focusing on Lanadelumab's Effectiveness and Impact on Quality of Life in The Kingdom of Saudi Arabia)","Inclusion Criteria:\n\n1. Participant is diagnosed with HAE-C1INH-Type 1 or HAE-C1INH-Type 2 and initiated on long-term prophylaxis (LTP) with Takhzyro® (lanadelumab).\n2. Participant is aged greater than or equal to (\\>=) 12 years at the time of Takhzyro® initiation.\n3. Participant has received at least 6 months of continuous treatment with Takhzyro® before data abstraction.\n\nExclusion Criteria:\n\n1. Participants who have normal C1INH function or HAE-nC1INH (formerly type III HAE).\n2. Participants who discontinued Takhzyro® before completing 6 months of treatment.\n3. Participants with insufficient or incomplete medical records which prevent the assessment of baseline HAE-AS at the time of Takhzyro® initiation, as well as 6 months HAE-AS after treatment initiation.\n4. Participants who are participating in an interventional clinical trial involving other HAE-C1INH treatments during the observation period.",{"count":166,"type":20},50,"Hereditary angioedema (HAE) is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels but does not cause itching or hives. HAE is classified based on the amount of a protein in the blood called C1 inhibitor (C1INH): HAE with normal C1INH levels (HAE-nC1INH) and HAE with limited or insufficient C1INH levels (HAE-C1INH); HAE-C1INH can be divided into Type 1, with low levels of C1INH, and Type 2, in which the protein is there, but does not work properly. This study will concentrate on people with HAE-C1INH Type 1 or 2 who have received Takhzyro® (lanadelumab) as prophylactic treatment for at least half a year (6 months). Prophylactic means that treatment is given to prevent the happening of HAE attacks.\n\nThe main goal of the study is to see how well Takhzyro® works in everyday life to reduce the condition's activity after 6 months of treatment, or 12 months (if data is available). This will be measured by checking the change of the HAE activity from before treatment to after 6 months of treatment.\n\nThe study design will permit a study follow-up of up to 12 months following the index event (i.e. date of first dose administration of Takhzyro®) unless the patient discontinues the index treatment, dies or is lost to follow-up within this timeframe. Chart abstractions will only occur once patients have at least 6 months' duration between the index event date and the date of chart abstraction initiation. Other goals are to find out how a person's quality of life changes after using Takhzyro® for 6 months, how often they had attacks before and after treatment and to learn which factors may have an impact on the treatment.\n\nThe study will only look at data already existing in the participants' medical records. No treatment will be given as part of the study.",[24],[26],"2026-05-06",{"date":172,"type":31},"2026-05-11",{"date":174,"type":31},"2026-04-30",{"date":176,"type":20},"2026-10-30",{"name":37,"class":38},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":92,"phases":188,"briefSummary":189,"conditions":190,"keywords":191,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100568335","phase-3-long-term-open-label-study-of-oral-deucrictibant-extended-release-tablet-for-prophylaxis-against-angioedema-attacks-in-adolescents-and-adults-with-hae-100568335","NCT06679881","Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE","A Long-term, Open-label Study to Evaluate the Safety and Efficacy of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema","CHAPTER-4","Inclusion Criteria:\n\n1. Provision of the signed ICF by the participant and\u002For legally designated representative.\n2. Male or female, aged ≥12 years at the time of providing written informed consent\u002Fassent.\n3. Diagnosis of hereditary angioedema (HAE)\n4. For participants that did not participate in a previous deucrictibant prophylactic study: history of at least 1 attack in the last 3 consecutive months prior to Screening\n5. Reliable access and ability to use standard of care on-demand treatments to effectively manage acute HAE attacks.\n6. Willing and able to adhere to all protocol requirements, including eDiary and ePRO data recording.\n7. Female participants of childbearing must agree to the protocol specified pregnancy testing and contraception methods.\n\nExclusion Criteria:\n\n1. Any diagnosis of angioedema other than HAE\n2. Participation in a clinical study with any other investigational drug within the last 30 days or within 5 half-lives of the investigational drug at ICF signature (whichever is longer)\n3. Prior gene therapy for any indication at any time\n4. Participants who discontinued from previous studies with deucrictibant prophylactic and\u002For on-demand treatment due to safety reasons or compliance issues that, in the opinion of the Investigator, would interfere with the participant's safety or compliance to participate in the study\n5. Exposure to ACE inhibitors or any estrogen-containing medications with systemic absorption within 4 weeks of Screening\n6. Use of prophylactic treatment for HAE within 2 weeks of Screening for C1INH, oral kallikrein inhibitors, or anti-fibrinolytics; within 4 weeks of Screening for attenuated androgens; within 5 half-lives of Screening for monoclonal antibodies, or within 7 days of Screening for short-term prophylaxis\n7. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding\n8. Abnormal hepatic function\n9. Moderate or severe renal impairment\n10. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.\n11. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse\n12. Use of medications that are moderate and strong inhibitors or strong inducers of CYP3A4 within the last 30 days or within 5 half-lives (whichever is longer) of the time of randomization\n13. Known hypersensitivity to deucrictibant or any of the excipients of the study drug",{"count":187,"type":20},170,[94],"This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema",[24],[99,192,193,194,195,196,197],"Oral Treatment","Bradykinin B2 Receptor Antagonists","PHVS719","PHA121","Deucrictibant","Prophylaxis",{"date":199,"type":31},"2026-05-07",{"date":201,"type":31},"2025-02-01",{"date":203,"type":20},"2028-12",{"name":205,"class":38},"Pharvaris Netherlands B.V.",62,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":67,"enrollmentInfo":4,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":221,"locationsCount":4},"100605203","post-study-access-of-csl312-garadacimab-for-pediatric-participants-with-hereditary-angioedema-who-have-completed-the-csl3123003-study-100605203","NCT07159464","Post Study Access of CSL312 (Garadacimab) for Pediatric Participants With Hereditary Angioedema Who Have Completed the CSL312_3003 Study","Post Study Access of CSL312 (Garadacimab) for the Routine Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Participants (2-11 Years Old) With HAE Who Have Completed the CSL312_3003 Study","Inclusion Criteria:\n\n* Completion of treatment period in study CSL312\\_3003 (NCT05819775)\n* The participant responded to CSL312 treatment with no or very limited number of HAE attacks during the CSL312\\_3003 study\n* The participant experienced no clinically significant adverse effects associated with CSL312 treatment\n* In the opinion of the treating physician, the participant continues to receive benefit from CSL312\n* There is no other suitable alternative prophylactic treatment available at the time of consenting into the Post Study Access program\n\nExclusion Criteria:\n\n* In the opinion of the treating physician, participant may not be compliant with the Protocol requirements\n* Participant is 12 years or older at the time of consent\n* In the opinion of the treating physician, other study medication of prophylaxis treatment of HAE may benefit the participant more than continuing treatment with CSL312\n* Participant who is pregnant, breastfeeding, or not willing to cease breastfeeding","EXPANDED_ACCESS","This protocol for post study access allows pediatric participants (2-11 years old at the time of consent) with HAE who have completed study CSL312\\_3003 (NCT05819775) to continue treatment with CSL312 for routine prevention of HAE attacks. The continuing treatment with the study product will be administered under a Post Study Access program in accordance with the applicable laws and regulations, to be dictated by CSL Behring (Sponsor) and approved by the appropriate local\u002Fcentral Ethics Committees and all other competent authorities required by law, as applicable.",[24],"AVAILABLE","2025-08-28",{"date":220,"type":31},"2025-09-08",{"name":222,"class":38},"CSL Behring",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":92,"phases":233,"briefSummary":236,"conditions":237,"keywords":241,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":157},"100596541","phase-1-oral-deucrictibant-for-prophylactic-and-acute-treatment-in-hereditary-angioedema-patients-100596541","NCT07046806","Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients","Oral Deucrictibant for the Prophylactic and Acute Treatment in Patients With Bradykinin Mediated Angioedema With Normal C1 Inhibitor (BK-AE-nC1INH)","BK-AE-nC1INH","Inclusion Criteria:\n\n1. Provision of written informed consent.\n2. Male or female, aged ≥18 at the time of provision of informed consent.\n3. Diagnosis of bradykinin-mediated angioedema based upon all of the following:\n\n   * Clinical history consistent with angioedema (subcutaneous or mucosal, nonpruritic swelling without accompanying urticaria), not responsive to treatments of anti-histamine, corticosteroid, and\u002For omalizumab.\n   * Tried and failed at least 2 weeks of cetirizine 20 mg twice a day (or its equivalent alternative antihistamines, such as fexofenadine, loratadine, desloratadine or levocetirizine, etc.).\n   * Total blood BK peptide levels following 3 days cold activation is above the diagnostic value in non-attack and\u002For attack period\\*.\n\n     \\*The \"attack period\" is defined as within 24 hours after an attack.\n   * Documented diagnostic testing results: C1INH antigen concentration and functional activity within normal range; C4 antigen concentration within normal range.\n4. Documented history of at least 2 angioedema attacks in the previous 2 months.\n5. Reliable access and experience to use standard of care medication to effectively manage acute angioedema attacks.\n\nExclusion Criteria:\n\n1. Any diagnosis of angioedema other than BK-AE-nC1INH.\n2. Participation in a clinical study with any other investigational drug within the previous 30 days or within 5 half-lives of the investigational drug at Screening (whichever was longer).\n3. Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 4 weeks of Screening.\n4. Receiving prophylactic treatment for BK-AE-nC1INH. Participants who have previously received prophylactic therapy but have stopped can participate in this study provided a sufficiently long washout period (≥5 half-life) is observed before the participant is screened. Exclusion includes use of:\n\n   • Short-term prophylaxis for BK-AE-nC1INH within 7 days prior to Screening.\n5. Any females who are pregnant, plan to become pregnant, or are currently breast-feeding.\n6. Abnormal hepatic function (aspartate aminotransferase \\>2× upper limit of normal, alanine aminotransferase \\>2× ULN, or total bilirubin \\>1.5× upper limit of normal). Participants with Gilbert's syndrome, defined as isolated increase of total bilirubin ≤3× upper limit of normal and aspartate aminotransferase and alanine aminotransferase within the normal range, are not excluded.\n7. Abnormal renal function (estimated glomerular filtration rate \\[eGFR\\] \\\u003C60 mL\u002Fmin\u002F1.73 m2).\n8. Any clinically significant history of angina, myocardial infarction, syncope, stroke, left ventricular hypertrophy or cardiomyopathy, uncontrolled hypertension, bradycardia, or any other clinically significant cardiovascular abnormality within the previous year that, in the opinion of the Investigator, would interfere with the participant's safety or ability to participate in the study.\n9. History of epilepsy and other significant neurological diseases.\n10. Any clinically significant gastrointestinal dysfunction (eg, diarrhea, inflammatory bowel disease) which may impact on study drug absorption.\n11. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.\n12. Use of concomitant medications with systemic absorption that are moderate and strong inhibitors or strong inducers of CYP3A4, such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, and grapefruit juice as well as carbamazepine, and rifampin within the last 30◦days or within 5◦half-lives (whichever is longer) of the time of randomization.\n13. Known hypersensitivity to deucrictibant or any of the excipients of study drug.","75 Years",{"count":134,"type":20},[234,235],"PHASE1","PHASE2","To assess the efficacy of prophylactic treatment with deucrictibant extended release (XR) tablet versus placebo in preventing angioedema attacks, and to also assess the efficacy of deucrictibant soft capsules as on-demand treatment versus placebo in achieving angioedema symptom relief during acute attacks.",[24,238,239,240],"Angioedema","Bradykinin-mediated Angioedema","C1 Inhibitor Deficiency",[242,243,99,229,244,245,246],"Bradykinin","deucrictibant","nC1INH","C1 Inhibitor","C4","2025-06-23",{"date":249,"type":31},"2025-07-02",{"date":251,"type":31},"2025-03-10",{"date":253,"type":20},"2026-04-01",{"name":255,"class":256},"Institute for Asthma and Allergy","NETWORK",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":266,"conditions":267,"keywords":270,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":4},"100578451","suicide-ideation-in-hereditary-angioedema-100578451","NCT06811467","Suicide Ideation in Hereditary Angioedema","Suicidal Ideation in Hereditary Angioedema","HAE-SAFE","Inclusion Criteria:\n\n* Confirmed diagnosis of hereditary angioedema\n* Over the age of 18\n\nExclusion Criteria:\n\n* Patients with intellectual disability\n* Refusal to participate in the study\n* Patients with acquired C1-INH deficiency\n* Patients with other dermatological diseases.",{"count":49,"type":20},"This study focuses on patients with Hereditary Angioedema (HAE) to better understand how mental health affects overall well-being. Through a questionnaire, the investigators will assess the presence of suicidal thoughts, anxiety, and depression, as well as cardiovascular risk markers. By analyzing these factors together, the investigators aim to identify possible links between mental health and heart health in people with HAE. This research will help improve care strategies and highlight the importance of mental well-being in managing HAE.",[24,268,269],"Suicidal Ideation","Cardiovascular Risk",[271,272,273,274],"Hereditary Angioedema","Suicidal ideation","TyG-BMI","cardiovascular risk","2025-02-06",{"date":277,"type":31},"2025-02-10",{"date":279,"type":20},"2025-03-01",{"date":281,"type":20},"2025-09",{"name":283,"class":284},"Ivan Cherrez Ojeda","OTHER"]