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A phase 4 open-label study to evaluate the safety after switching to CSL312 (Garadacimab) from current prophylactic HAE treatment in subjects with HAE ≥ 12 years of age

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517757-27-00
Acronym
CSL312_4002
Enrollment
5
Registered
2025-08-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema (HAE)

Brief summary

1. Number of Participants with Treatment Emergent Adverse Events (TEAEs), 2. Percentage of Participants with TEAEs, 3. Number of TEAEs, 4. Rate of TEAEs per injection, 5. Rate of TEAEs per participant year

Detailed description

1. Number of Participants With: Serious Adverse Events (SAEs), Deaths, Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and Adverse Events of Special Interest (AESI), 2. Percentage of Participants With: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 3. Number of SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, AESI and Laboratory Findings Reported as an AE, and AESI, 4. Rate per injection of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 5. Rate per participant year of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 6. Number of Participants with Anti-garadacimab Antibodies, 7. Percentage of Participants with Anti-garadacimab Antibodies, 8. Plasma Concentrations of Garadacimab, 9. Percentage of Participants who Indicated Their Preference for Garadacimab

Interventions

Sponsors

CSL Behring LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Number of Participants with Treatment Emergent Adverse Events (TEAEs), 2. Percentage of Participants with TEAEs, 3. Number of TEAEs, 4. Rate of TEAEs per injection, 5. Rate of TEAEs per participant year

Secondary

MeasureTime frame
1. Number of Participants With: Serious Adverse Events (SAEs), Deaths, Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and Adverse Events of Special Interest (AESI), 2. Percentage of Participants With: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 3. Number of SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, AESI and Laboratory Findings Reported as an AE, and AESI, 4. Rate per injection of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 5. Rate per participant year of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI, 6. Number of Participants with Anti-garadacimab Antibodies, 7.

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026