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

Shire83 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hereditary Angioedema (HAE)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (20)

Universitair Ziekenhuis Antwerpen (UZA)

Antwerp, Edegem, Belgium

Clinic St-Luc University Hospital

Brussels, Belgium

Outcomes

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

Data from ClinicalTrials.gov

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