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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01541423
Recruitment Status : Completed
First Posted : March 1, 2012
Last Update Posted : October 24, 2016
Information provided by (Responsible Party):

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.

Condition or disease
Hereditary Angioedema (HAE)

Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : March 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Incidence of adverse drug reactions [ Time Frame: 12 months ]
  2. Incidence of thrombotic/thromboembolic events [ Time Frame: 12 months ]
  3. Occurrence of pregnancy [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01541423

Universitair Ziekenhuis Antwerpen (UZA)
Antwerp, Edegem, Belgium, 2650
Clinic St-Luc University Hospital
Brussels, Belgium
CHU d'Angers
Angers, France, 49033
Hôpital Claude-Huriez
Lille, France, 59037
Immunologie Clinique et Allergologie
Nancy, France, 54500
Hôpital Saint Antoine
Paris, France, 75571
Université Paris Descartes
Paris, France, 75679
Berlin, Germany, 10117
Universitätsklinik Essen
Essen, Germany, 45122
Johann Wolfgang Goethe Universität
Frankfurt, Germany, 60590
Universität-Hautklinik Mainz
Mainz, Germany, 55131
Hämophilie-Zentrum Rhein Main
Mörfelden-Walldorf, Germany, D-64546
Klinikum rechts der Isar der technischen Universität München
München, Germany, 81675
Ospedale Luigi Sacco
Milano, Italy, 20157
Azienda Ospedaliera "V. Cervello"
Palermo, Italy, 90146
C.A.R San Pedro
Logrono, Spain, 26003
Hospital General Universitario
Madrid, Spain, 28007
Hospital Universitario La Paz
Madrid, Spain, 28046
United Kingdom
Barts and the London NHS Trust
London, United Kingdom, E1 2ES
Northern General Hospital
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Study Director: Irmgard Andersen, MD, FFPM Shire

Responsible Party: Shire Identifier: NCT01541423     History of Changes
Other Study ID Numbers: 0624-401
First Posted: March 1, 2012    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Genetic Diseases, Inborn