C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)

Phase 3

Completed

• Conditions: Hereditary Angioedema
• Interventions: Drug: C1 Esterase Inhibitor

• Registration Number: NCT00292981
• Lead Sponsor: CSL Behring

Brief Summary

Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of involvement of the larynx.The planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24 months or until the licensing procedure for C1-INH is finalized, whatever comes first.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-02-15
• Study First Submitted QC: 2006-02-15
• Study First Posted: 2006-02-16
• Primary Completion: 2010-02
• Study Completion: 2010-05
• Results First Submitted: 2011-05-25
• Results First Submitted QC: 2011-05-25
• Results First Posted: 2011-06-23
• Status Verified: 2011-10
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Documented congenital C1-INH deficiency
• Acute HAE attack
• Participation in base study CE1145_3001 (NCT00168103)

Key

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Exclusion Criteria

• Acquired angioedema
• Treatment with any other investigational drug besides CE1145 in the last 30 days before study entry

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C1 Esterase Inhibitor	C1 Esterase Inhibitor	-

Primary Outcome Measures

Name	Time	Method
Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)	Up to 24 h after start of study treatment	The start of symptom relief was determined by subject self-assessment.
Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)	Up to 24 h after start of study treatment	The start of symptom relief was determined by subject self-assessment.

Secondary Outcome Measures

Name	Time	Method
Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)	Up to Day 9 following an attack	Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.
Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)	Up to Day 9 following an attack	Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.

Trial Locations

Locations (1)

Contact CSL Behring for facility details; 🇨🇦 Ottawa, Ontario, Canada