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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Aug 2005

Longer than P75 for phase_3

Geographic Reach

2 countries

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.8 years study duration

Study Start

First participant enrolled

August 1, 2005

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2006

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

June 23, 2011

Completed

Last Updated

May 7, 2015

Status Verified

October 1, 2011

Enrollment Period

4.5 years

First QC Date

February 15, 2006

Results QC Date

May 25, 2011

Last Update Submit

April 20, 2015

Conditions

Hereditary Angioedema

Keywords

C1 InhibitorHereditary angioedemaAcute HAE attack

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (2)

Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)
Up to Day 9 following an attack
Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)
Up to Day 9 following an attack

Study Arms (1)

C1 Esterase Inhibitor

EXPERIMENTAL

Drug: C1 Esterase Inhibitor

Interventions

C1 Esterase InhibitorDRUG

Lyophilisate containing approximately 500 U C1-INH to be reconstituted with 10 mL water for injection; Single Dose: 20 U/kg b.w. iv

Also known as: Berinert P

C1 Esterase Inhibitor

Eligibility Criteria

Age6 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Documented congenital C1-INH deficiency
Acute HAE attack
Participation in base study CE1145\_3001 (NCT00168103)

You may not qualify if:

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

Contact the study team to confirm eligibility.