NCT00438815

Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks

LEVP2006-1 CHANGE 2 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Safety/Efficacy Repeat Exposure Study of C1INH-nf (Human) in the Treatment of Acute HAE Attacks

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

The study objective was to evaluate the safety and efficacy of repeat use of C1INH-nf for the treatment of acute HAE attacks.

Detailed description

A total of 113 subjects were enrolled in the study. One-hundred-one (101) subjects received C1INH-nf for the treatment of 1 or more HAE attacks and were analyzed for efficacy. The study design also allowed for short-term prophylaxis with C1INH-nf prior to emergency or non-cosmetic surgical or dental procedures, and an additional 12 subjects received C1INH-nf only for this purpose. All 113 subjects were exposed to C1INH-nf and analyzed for safety.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
BIOLOGICAL	C1 esterase inhibitor [human] (C1INH-nf)

Timeline

• Start date: 2006-09-21
• Primary completion: 2009-03-31
• Completion: 2009-03-31
• First posted: 2007-02-22
• Last updated: 2021-06-08
• Results posted: 2010-06-09

Locations

30 sites across 1 country: United States