Condition: Hereditary Angioedemas · Sponsor: CSL Behring
This is a multinational, multicenter, prospective, observational cohort study of patients with HAE in the real-world setting. The study will include patients newly initiating garadacimab in routine clinical practice. Each participant will be followed for 48 months after index date (date of the first administration of garadacimab). Patient data will be collected from the HAE eDiary, patient medical records (MRs) and/or during a routine clinical visit and will be entered into the electronic case report form (eCRF) via an electronic data capture (EDC) system. Data pertaining to HAE attacks, prior HAE treatments, retrospective focused safety data collection, and healthcare resource utilization (HCRU) over a look-back period of 12 months prior to the enrollment will be extracted from the MR, and patients will also record retrospective HAE attack related data over a look-back period of 3 months prior to enrollment in the HAE eDiary. The primary aim of this study is to investigate the real-world effectiveness of garadacimab as measured by HAE attack rate before and after garadacimab initiation in patients with HAE over 24 months of follow-up. The study will aim to complement the data available from the clinical development program on the efficacy, safety, and health-related quality-of-life (HRQoL) in patients with HAE taking garadacimab.
This description comes directly from the study's public registry record.
Trial Registration Coordinator · +1 610-878-4697 · clinicaltrials@cslbehring.com
Always discuss trial participation with your own doctor first.
| Medical Research of Arizona | Phoenix, Arizona, United States | Recruiting |
| Sirven and Associates | Miami, Florida, United States | Recruiting |
| Asthma and Allergy Wellness Center | Saint Charles, Illinois, United States | Recruiting |
| Family Allergy and Asthma | Louisville, Kentucky, United States | Not Yet Recruiting |
| John Hopkins University | Baltimore, Maryland, United States | Active Not Recruiting |
| Washington University | St Louis, Missouri, United States | Active Not Recruiting |
| Riverside Medical Group, Belleville | Belleville, New Jersey, United States | Recruiting |
| Kepler Universitätsklinikum - Med Campus III. | Linz, Austria | Recruiting |
| Providence Health Care Society | Vancouver, British Columbia, Canada | Recruiting |
| Universitaetsklinikum Ulm | Ulm, Baden-Wurttemberg, Germany | Recruiting |
| HZRM Haemophilie-Zentrum Rhein Main | Frankfurt am Main, Hesse, Germany | Active Not Recruiting |
| Medizinische Hochschule Hannover | Hanover, Lower Saxony, Germany | Active Not Recruiting |
+ 10 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07001280