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Ruconest for prophylaxis in hereditary angioedema
NCT00851409Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2009
- Primary completion
- Mar 2010
- Countries
- 2
- Sponsor
- Pharming Group
- Conditions
- hereditary angioedema (HAE)
01
Overview
Phase 2, open-label, single-arm trial of c1-esterase inhibitor in hereditary angioedema (HAE), sponsored by Pharming Group. Primary endpoint: Hereditary Angioedema Attacks per Week at 8 weeks. Started Jun 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Recombinant Human C1 Inhibitor
Weekly administration of 50 IU/kg Recombinant Human C1 Inhibitor
03
Who it enrols
Adults with confirmed HAE (low C1INH activity or mutation) who have not received plasma-derived C1INH in the last 3 months and have no rabbit protein allergies; women of childbearing potential are excluded.
04
Endpoints
Primary
Hereditary Angioedema Attacks per Week
Secondary
Pharmacokinetic and Pharmacodynamic Parameters
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