Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

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.

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Key information

Conditions

Hereditary Angioedema Types I and II Angioedema Angioedemas, Hereditary Cardiovascular Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MHAT "Tsaritsa Yoanna", Sofia, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. Each attack that occurs in this time frame will be treated with 20 IU Berinert/kg body weight.

Primary outcomes

Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies

Time frame: Baseline to approximately 9 months

Subjects with no positive baseline result and at least one positive post-baseline result for inhibitory anti-C1-INH antibodies.

Secondary outcomes

Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies

Time frame: Baseline to approximately 9 months

Subjects with at least one positive result for inhibitory or non-inhibitory anti-C1-INH antibodies.

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Nov 9, 2011
Registry last updated: Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed