Status:
COMPLETED
A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
Lead Sponsor:
CSL Behring
Conditions:
Hereditary Angioedema Types I and II
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The ...
Eligibility Criteria
Inclusion
- Run-In Period
- Males or females aged 12 years or older.
- A clinical diagnosis of hereditary angioedema type I or II.
- Hereditary angioedema attacks over a consecutive 2-month period that required acute treatment, medical attention, or caused significant functional impairment.
- For subjects who have used oral therapy for prophylaxis against HAE attacks within 3 months of Screening: use of a stable regimen within 3 months of Screening, with no plans to change.
- Eligibility Criteria for Entering Treatment Period 1:
- Laboratory confirmation of type I or type II hereditary angioedema, including C1-esterase inhibitor functional activity less than 50% AND C4 antigen level below the laboratory reference range.
- No clinically significant abnormalities as assessed using laboratory parameters.
- During participation in the run-in period, subjects must have experienced hereditary angioedema attacks that required acute treatment, required medical attention, or caused significant functional impairment.
Exclusion
- Run-In Period
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01912456
Start Date
January 1 2014
End Date
October 1 2015
Last Update
January 29 2021
Active Locations (39)
Enter a location and click search to find clinical trials sorted by distance.
1
Study Site
Birmingham, Alabama, United States, 35209
2
Study Site
Scottsdale, Arizona, United States, 85251
3
Study Site
Bell Gardens, California, United States, 90201
4
Study Site
La Jolla, California, United States, 92093