Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
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 lead to a
decrease in the blood level of functional "C1INH". This multi-center study was designed to
assess the safety and tolerability, efficacy, and pharmacokinetics/pharmacodynamics of
recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema
attacks.
Funding Source - FDA OOPD
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Pharming Technologies B.V.
Treatments:
Complement C1 Inactivator Proteins Complement C1 Inhibitor Protein