Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

CSL Behring

Status and phase

Completed

Phase 4

Conditions

Hereditary Angioedema Types I and II

Treatments

Biological: Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01467947

CE1145_4001

2010-024242-30 (EudraCT Number)

Details and patient eligibility

About

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 treated intravenously with Berinert. Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. All subjects will receive 20 IU Berinert/kg body weight per attack.

Enrollment

46 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.