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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517757-27-00 | Other Identifier | EU CT Number |
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This study is designed to evaluate the safety after switching to garadacimab from another prophylactic hereditary angioedema (HAE) treatment (marketed kallikrein [KK] inhibitor or plasma-derived C1-esterase inhibitor [pdC1INH]prophylactic) when administered once monthly for approximately 3 months in participants aged greater than or equal to (>=) 12 years with HAE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Garadacimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Garadacimab | Biological | Participants will receive a loading dose of garadacimab, followed by once monthly garadacimab administration for 2 months. Garadacimab will be given as a subcutaneous injection. The timing for the administration of the loading dose (first administration of garadacimab) is determined by the dosing schedule of the current HAE prophylactic treatment. No washout necessary. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to Day 95 (End of study [EoS]) | |
| Percentage of Participants With TEAEs | Up to Day 95 (EoS) | |
| Number of TEAEs | Up to Day 95 (EoS) | |
| Rate of TEAEs per injection | Up to Day 95 (EoS) | |
| Rate of TEAEs per participant year | Up to Day 95 (EoS) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With: Serious Adverse Events (SAEs), Deaths, Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and Adverse Events of Special Interest (AESI) | The AESIs for garadacimab are severe hypersensitivity including anaphylaxis. | Up to Day 95 (EoS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Solutions of Arizona | Litchfield Park | Arizona | 85340 | United States | ||
| Allergy and Asthma Clinic of Northwest Arkansas |
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Requests for IPD will generally be considered once review by major regulatory authorities (i.e. FDA, EMA) is complete and the primary publication is available
Proposed research should seek to answer a previously unanswered important medical or scientific question.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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|
|
| Percentage of Participants With: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI |
| Up to Day 95 (EoS) |
| Number of SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, AESI and Laboratory Findings Reported as an AE, and AESI | Up to Day 95 (EoS) |
| Rate per injection of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI | Up to Day 95 (EoS) |
| Rate per participant year of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI | Up to Day 95 (EoS) |
| Number of Participants with Anti-garadacimab Antibodies | Up to Day 95 (EoS) |
| Percentage of Participants with Anti-garadacimab Antibodies | Up to Day 95 (EoS) |
| Plasma Concentrations of Garadacimab | Up to Day 95 (EoS) |
| Percentage of Participants who Indicated Their Preference for Garadacimab | Up to Day 95 (EoS) |
| Bentonville |
| Arkansas |
| 72712 |
| United States |
| Donald Levy M.D. | Orange | California | 92868 | United States |
| Raffi Tachdjian MD, Inc. | Santa Monica | California | 90404 | United States |
| Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | 45236 | United States |
| Chronicle Bio | West Valley City | Utah | 84119 | United States |
| McMaster University-Hamilton | Hamilton | Ontario | ON L8N3Z5 | Canada |
| Montreal Clinical Research Institute | Montreal | Quebec | QC H2W 1R7 | Canada |
| Clinique Spécialisée en Allergie de la Capitale | Québec | G1V 4W2 | Canada |
| HZRM Hämophilie Zentrum Rhein Main GmbH | Frankfurt | 60596 | Germany |
| Hautklinik und Poliklinik der Universitätsklinik Mainz | Mainz | 55131 | Germany |
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
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