NCT00262301

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Pharming Technologies B.V. · Industry
• Sex: All
• Age: 16 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 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.

Detailed description

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

Conditions

• Hereditary Angioedema
• Angioneurotic Edema
• Genetic Disorders

Interventions

Type	Name	Description
DRUG	recombinant human C1 inhibitor	IV
DRUG	Placebo	IV

Timeline

• Start date: 2004-06-01
• Primary completion: 2009-07-01
• Completion: 2009-10-01
• First posted: 2005-12-06
• Last updated: 2012-10-02
• Results posted: 2012-08-30

Locations

2 sites across 2 countries: Netherlands, Romania