Hereditary Angioedema Types I and II

Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

NCT01467947 | PHASE 4 | INTERVENTIONAL

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.

4 Sites

46 Participants

Recruiting

12 Years to 55 Years

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SUBMIT

MHAT "Tsaritsa Yoanna"

Sofia,Bulgaria,1504

Semmelweis University

Budapest,Hungary,1125

Jagiellonian University

Krakow,Poland,31-531

Spitalul Clinic Judeean Mure,Secia Clinic Medicin Intern,Compartimentul Alergologie i Imunologie

Târgu-Mures,Mureş,Romania,Cod540103

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov