Overview

Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
Summary
Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that leads to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy and pharmacodynamics/ pharmacokinetics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pharming Technologies B.V.
Treatments:
Complement C1 Inactivator Proteins
Complement C1 Inhibitor Protein
Criteria
Inclusion Criteria:

- Clear clinical and laboratory diagnosis of HAE

- Baseline plasma level of functional C1INH of less than 50% of normal

- Evidence for exacerbation or development of a severe abdominal, oro-facial/
pharyngeal/ laryngeal, genito-urinary and/or peripheral HAE attack

Exclusion Criteria:

- Acquired angioedema

- Pregnancy or breastfeeding

- Participation in another clinical study within prior 3 months