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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01541423

Enrollment

Registered

2012-03-01

Start date

2012-05-11

Completion date

2016-09-25

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema (HAE)

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse drug reactions	12 months
Incidence of thrombotic/thromboembolic events	12 months
Occurrence of pregnancy	12 months

Countries

Belgium, France, Germany, Italy, Spain, United Kingdom

Outcome results