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1
Study Matches
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
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.