- Male or female
- Aged 2 to 11 years, inclusive, with body weight ≥ 10th percentile based on age
- Diagnosed with clinically confirmed C1-INH HAE
- Experienced ≥ 2 HAE attacks during the 6 months before Screening
Hereditary Angioedema (HAE)
CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema
NCT05819775 | Phase 3 | Interventional
The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.
Trial Information
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Barzilai University Medical Center
Ashkelon,Israel,7830604
Study Eligibility Criteria
- Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria, or HAE type III
- Any preplanned major surgeries or procedures during the clinical study
- Use of C1-INH products, androgens, antifibrinolytics, approved or future approved medications, or other small molecule medications for routine prophylaxis against HAE attacks
- Participation in another interventional clinical study
Additional Studies
Additional studies can be found at ClinicalTrials.gov