Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

CSL Behring46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hereditary Angioedema Types I and II

Interventions

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

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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (4)

MHAT "Tsaritsa Yoanna"

Sofia, Bulgaria

Semmelweis University

Budapest, Hungary

Jagiellonian University

Krakow, Krakow, Poland

Spitalul Clinic Judeţean Mureş,Secţia Clinică Medicină Internă,Compartimentul Alergologie şi Imunologie

Târgu-Mures, Mureș County, Romania

Outcomes

Primary Outcomes

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

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

Time frame: Baseline to approximately 9 months

Secondary Outcomes

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

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

Time frame: Baseline to approximately 9 months

Data from ClinicalTrials.gov

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