Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

Phase 4

Completed

• Conditions: Hereditary Angioedema Types I and II
• Interventions: Biological: Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection

• Registration Number: NCT01467947
• Lead Sponsor: CSL Behring

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-10
• Results First Submitted: 2015-10-16
• Results First Submitted QC: 2015-10-16
• Results First Posted: 2015-11-16
• Last Update Submitted: 2016-12-12
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies	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 Outcome Measures

Name	Time	Method
Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies	Baseline to approximately 9 months	Subjects with at least one positive result for inhibitory or non-inhibitory anti-C1-INH antibodies.

Trial Locations

Locations (4)

Spitalul Clinic Judeţean Mureş,Secţia Clinică Medicină Internă,Compartimentul Alergologie şi Imunologie; 🇷🇴 Târgu-Mures, Mureş, Romania

MHAT "Tsaritsa Yoanna"; 🇧🇬 Sofia, Bulgaria

Jagiellonian University; 🇵🇱 Krakow, Poland

Semmelweis University; 🇭🇺 Budapest, Hungary