EUCTR2014-001054-42-ITActive, not recruitingPhase 1
An open-label, randomized study to evaluate the long-term clinical safety and efficacy of subcutaneous administration of human plasma-derived C1-esterase inhibitor in the prophylactic treatment of hereditary angioedema - not available
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- CSL BEHRING GMBH
- Enrollment
- 126
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Males or females aged 6 years or older.
- •A confirmed diagnosis of HAE type I or II.
- •HAE attacks over a consecutive 2-month period that required acute
- •treatment, medical attention, or caused significant functional
- •impairment.
- •For subjects who have used oral therapy for prophylaxis against HAE
- •attacks within 3 months of first study visit: use of a stable regimen
- •within 3 months of the first study visit.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 11
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
Exclusion Criteria
- •Incurable malignancies.
- •- Any clinical condition that will interfere with the evaluation of C1-INH therapy.
- •- Clinically significant history of poor response to C1-esterase therapy for the management of HAE.
- •- Suspected or confirmed diagnosis of acquired HAE or HAE with normal C1-INH.
- •Inability to have HAE managed pharmacologically with on-demand treatment
Investigators
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