A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema

This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3) treatment of angioedema attacks.

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Key information

Conditions

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Antwerpen (UZA), Antwerp, Edegem, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All patients must:

Have a diagnosis of HAE and be receiving CINRYZE for prevention or treatment of angioedema attacks
Provide written informed consent/assent in compliance with applicable country-specific and local regulations

Exclusion criteria

All patients must not:

Be receiving CINRYZE in an investigational study
Be receiving another HAE therapy as part of a clinical trial

Treatment and study plan

Primary outcomes

Incidence of adverse drug reactions

Time frame: 12 months
Incidence of thrombotic/thromboembolic events

Time frame: 12 months
Occurrence of pregnancy

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A European Multi-Center, Multi-Country, Post-Authorisation, Observational Study (Registry) Of Patients With Hereditary Angioedema (HAE) Who Are Administered CINRYZE® (C1 Inhibitor [Human]) For The Treatment Or Prevention Of HAE Attacks

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Mar 1, 2012
Registry last updated: Mar 17, 2021

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.

Published trials that share one or more normalized conditions with this study.

Completed