Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Behring
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males and females aged ≥ 12 years
Diagnosed with clinically confirmed C1-INH HAE
Experienced ≥ 3 HAE attacks during the 3 months before Screening
Participated in the Run-in Period for at least 1 month (CSL312-naïve subjects only)
Experienced at least an average of 1 HAE attack per month during the Run-in Period
You may not be if
Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria
Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period
Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
Female subjects use estrogen-containing oral contraceptives or hormone replacement therapy within 4 weeks prior to screening
Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 30 days after receipt of the last dose of CSL312
Pregnant, breastfeeding, or not willing to cease breastfeeding
Clareo Health | Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
