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An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema

This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC) once monthly for at least 12 months. Subjects entering CSL312_3002 will be from 3 sources: • Subjects who participated in Study CSL312_2001 • Subjects who participated in Study CSL312_3001 • CSL312-naïve HAE subjects who have not participated in either of the above studies

During the study, you will be expected to self-administer the study medication by injection under the skin once a month, complete a daily diary, provide blood and urine samples, complete questionnaires, undergo physical exams and have your vital signs recorded. You will visit the site 12 times.

$80.00 plus travel reimbursement

Timothy Craig
Kristina Richwine - at krichwine@pennstatehealth.psu.edu or 717-531-4506
 

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This study is NOT accepting healthy volunteers
NCT04739059
STUDY00017906
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Inclusion Criteria:
Able to understand and provide informed consent
Male or female
Diagnosed with clinically confirmed C1-INH HAE
Experienced ≥ 3 HAE attacks during the 3 months before Screening, as documented in the subject's medical record.
Aged ≥ 12 at the time of providing written informed consent or assent for minors
Exclusion Criteria:
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 mAbs such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
Female subjects’ use of estrogen-containing medications with systemic absorption (eg, oral contraceptive or hormonal replacement therapy within 4 weeks prior to the Run-in Period).
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 3 months after receipt of the last dose of CSL312.
Infectious Diseases & Immune System
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Hershey, PA ,