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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

The primary objective of this study is to evaluate the efficacy of SC administration of CSL312 as prophylaxis to prevent HAE attacks in subjects with HAE. The secondary objectives of the study are: 1. To characterize the clinical efficacy of SC CSL312 in the prophylactic treatment of HAE. 2. To evaluate the safety of SC CSL312 in the prophylactic treatment of HAE
Kristina Richwine at krichwine@pennstatehealth.psu.edu or 717-531-4506
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This study is NOT accepting healthy volunteers
NCT04656418
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Inclusion Criteria:
Capable of providing written informed consent
Male or female
Diagnosed with clinically confirmed C1-INH HAE
≥ 3 HAE attacks 3 months before screening
Exclusion Criteria:
Concomitant diagnosis of another form of angioedema
Any preplanned major surgeries or procedures during the clinical study
Use of C1-INH products, androgens, antifibrinolytics
Use of monoclonal antibodies such as lanadelumab (Takhzyro®)
Pregnant, breastfeeding, or not willing to cease breastfeeding
Allergies
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Location
Hershey, PA