Clinical trial NCT01541423: A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Angioedema (HAE)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-03-01
Enrollment: 83
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HAE in Europe who are receiving CINRYZE in routine clinical practice for prevention or treatment of angioedema attacks. Approximately 20 sites are planned for enrollment.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: 12 months
measure: Incidence of thrombotic/thromboembolic events
timeFrame: 12 months
measure: Occurrence of pregnancy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Universitair Ziekenhuis Antwerpen (UZA)
state: Edegem
city: Brussels
country: Belgium
facility: Clinic St-Luc University Hospital
city: Angers
country: France
facility: CHU d'Angers
city: Lille
country: France
facility: Hôpital Claude-Huriez
city: Nancy
country: France
facility: Immunologie Clinique et Allergologie
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Paris
country: France
facility: Université Paris Descartes
city: Berlin
country: Germany
facility: Allergie-Centrum-Charite
city: Essen
country: Germany
facility: Universitätsklinik Essen
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe Universität
city: Mainz
country: Germany
facility: Universität-Hautklinik Mainz
city: Mörfelden-Walldorf
country: Germany
facility: Hämophilie-Zentrum Rhein Main
city: München
country: Germany
facility: Klinikum rechts der Isar der technischen Universität München
city: Milano
country: Italy
facility: Ospedale Luigi Sacco
city: Palermo
country: Italy
facility: Azienda Ospedaliera "V. Cervello"
city: Logrono
country: Spain
facility: C.A.R San Pedro
city: Madrid
country: Spain
facility: Hospital General Universitario
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: London
country: United Kingdom
facility: Barts and the London NHS Trust
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: