Status:
COMPLETED
Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert
Lead Sponsor:
CSL Behring
Conditions:
Hereditary Angioedema Types I and II
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
This is a prospective, international, multi-center, non-randomized, single arm, open-label, postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE subjects treate...
Eligibility Criteria
Inclusion
- Diagnosis of congenital C1-INH deficiency (HAE type I or II) and assessed by the investigator to likely require intravenous (IV) Berinert treatment during the study period.
- Male or female, ≥ 12 years of age at the time of signing informed consent.
- Written informed consent for study participation obtained before undergoing any study specific procedures.
Exclusion
- Incurable malignancies in the last 6 months prior to study entry.
- Acquired angioedema due to C1-INH deficiency.
- All other types of angioedema not associated with C1-INH deficiency.
- Use of any C1-INH products other than Berinert within 30 days before the study, or planned use during the study.
- Immunization within 30 days prior to study entry.
- Autoimmune conditions requiring use of immunosuppressants during the study.
- Known or suspected hypersensitivity to C1-INH.
- Participation in any of the previous Berinert studies from which anti-C1-INH antibody results were submitted to the Food and Drug Administration.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01467947
Start Date
November 1 2011
End Date
October 1 2014
Last Update
February 6 2017
Active Locations (4)
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1
MHAT "Tsaritsa Yoanna"
Sofia, Bulgaria, 1504
2
Semmelweis University
Budapest, Hungary, 1125
3
Jagiellonian University
Krakow, Krakow, Poland, 31-531
4
Spitalul Clinic Judeţean Mureş,Secţia Clinică Medicină Internă,Compartimentul Alergologie şi Imunologie
Târgu-Mures, Mureș County, Romania, Cod 540103