NCT00225147

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

A Randomized, Placebo-controlled, Double Blind Phase II/III Study of the Safety and Efficacy of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Pharming Technologies B.V. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Detailed description

A prospectively planned interim analysis will be performed on the double-blind data.

Conditions

• Hereditary Angioedema
• Angioneurotic Edema

Interventions

Type	Name	Description
DRUG	Recombinant Human C1 Inhibitor	IV
DRUG	placebo	saline solution

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-10-01
• Completion: 2010-01-01
• First posted: 2005-09-23
• Last updated: 2013-02-22
• Results posted: 2012-08-31

Locations

1 site across 1 country: Netherlands