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

Phase 3

Recruiting

Conditions: 10027664
HAE
Hereditary angioedema

Registration Number: NL-OMON54235

Lead Sponsor: CSL Behring LLC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

1. Males and females aged >= 12 years
2. Diagnosed with clinically confirmed C1-INH HAE
3. Experienced >= 3 HAE attacks during the 3 months before Screening
4. Participated in the Run-in Period for at least 1 month (CSL312-naïve
subjects only)
5. Experienced at least an average of 1 HAE attack per month during the
Run-in Period

Exclusion Criteria

1. Concomitant diagnosis of another form of angioedema, such as idiopathic or
acquired angioedema or recurrent angioedema associated with urticaria
2. 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
3. Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before
the first day of the Run-in Period.
4. Female subjects use estrogen-containing oral contraceptives or hormone
replacement therapy within 4 weeks prior to screening
5. 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
6. Pregnant, breastfeeding, or not willing to cease breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to evaluate the long-term safety of SC<br /><br>administration of CSL312 in the prophylactic treatment of subjects with C1-INH<br /><br>HAE.</p><br>

Secondary Outcome Measures