Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Completed
Pharming Technologies B.V.
Phase 2/Phase 3
2005-07-01
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
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
Completed
Pharming Technologies B.V.
Phase 3
2004-06-01
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.
A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration
Completed
Pharming Technologies B.V.
Phase 2
2009-06-01
Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling
affecting various body locations. Recent literature shows that patients with frequent attacks
may benefit from long-term prophylaxis. This study aims to evaluate the safety and
prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor
("rhC1INH").
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