Clinical study where patients with hereditary angioedema (rapid swelling caused by an inherited condition) will be treated with a marketed drug called Berinert® to assess formation of inhibitory antibodies (proteins that may decrease the responsiveness to Berinert® and lead to requirement of higher doses of Berinert®)

Prospective open-label uncontrolled multi-center post-marketing study to assess inhibitory antibody formation in subjects with congenital C1-INH deficiency and acute hereditary angioedema (HAE) attacks treated with Berinert®, a C1-esterase inhibitor - n/a

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024242-30-PL

Enrollment

Registered

2011-08-29

Start date

2011-10-06

Completion date

Unknown

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital C1-INH deficiency and acute hereditary angioedema (HAE) attacks MedDRA version: 16.0 Level: PT Classification code 10019860 Term: Hereditary angioedema System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Berinert® Product Name: Berinert® Pharmaceutical Form: Powder and solution for solution for injection Current Sponsor code: CE1145 Other descriptive name: C1-esterase-inhibitor Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of congenital C1-INH deficiency (HAE type I or II) and assessed by the investigator to likely require 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. Are the trial subjects under 18? yes Number of subjects for this age range: 4 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: Incurable malignancies in the last 6 months prior to study entry. Acquired angioedema (AAE) due to C1-INH deficiency (eg, onset at >40 years of age, no family history of congenital C1-INH deficiency, low C1q plasma level, and no known HAE mutation). All other types of angioedema not associated with C1-INH deficiency (eg, including anaphylactic angioedema). Participation in another clinical study. 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. Alcohol, drug, or medication abuse within 1 year before the study. Suspected inability (eg, language problems) or unwillingness to comply with study procedures. Known or suspected hypersensitivity to C1-INH. Any condition that is likely to interfere with evaluation of the investigational medicinal product (IMP) or satisfactory conduct of the study. Employee at the study center, or spouse/partner or relative of anyone of the study staff. Participation in any of the previous Berinert studies from which anti-C1-INH antibody results were submitted to the Food and Drug Administration. Female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or for whom sexual abstinence for the entire duration of the study is not conceivable. Pregnant women (pregnancy test required), or intention to become pregnant during the course of the study, women currently breast-feeding, or with the intention to breast feed. Re-entry of subjects participating in the current study who had previously been withdrawn for any reason.

Design outcomes

Primary

Measure	Time frame
Main Objective: To document the formation of inhibitory anti-C1-esterase-inhibitor (anti-C1-INH) antibodies in subjects with HAE treated with Berinert. The study will evaluate the hypothesis that the incidence of inhibitory anti-C1-INH antibodies in subjects with HAE treated with Berinert is less than 20% of the total study population.;Secondary Objective: To document the safety of Berinert in subjects with HAE treated with Berinert. Exploratory Objective: To document the efficacy of Berinert in subjects with HAE treated with Berinert for all types of HAE attacks, and to compare efficacy in subjects with and without anti-C1-INH antibodies.;Primary end point(s): Incidence of inhibitory anti-C1-INH antibodies.;Timepoint(s) of evaluation of this end point: Days 91, 182 and 273	—

Measure

Time frame

Main Objective: To document the formation of inhibitory anti-C1-esterase-inhibitor (anti-C1-INH) antibodies in subjects with HAE treated with Berinert. The study will evaluate the hypothesis that the incidence of inhibitory anti-C1-INH antibodies in subjects with HAE treated with Berinert is less than 20% of the total study population.;Secondary Objective: To document the safety of Berinert in subjects with HAE treated with Berinert. Exploratory Objective: To document the efficacy of Berinert in subjects with HAE treated with Berinert for all types of HAE attacks, and to compare efficacy in subjects with and without anti-C1-INH antibodies.;Primary end point(s): Incidence of inhibitory anti-C1-INH antibodies.;Timepoint(s) of evaluation of this end point: Days 91, 182 and 273

—

Secondary

Measure	Time frame
Secondary end point(s): Proportion of subjects with any anti-C1-INH antibodies (inhibitory or non-inhibitory). Adverse events. Laboratory safety parameters. Vital signs. Time to onset of symptom relief. Time to complete resolution of HAE symptoms.;Timepoint(s) of evaluation of this end point: ongoing	—

Countries

Bulgaria, Hungary, Poland

Contacts

Public ContactDirector Project Operations

ICON Clincial Research GmbH

Gabriele.Schneider@iconplc.com4961039040

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026