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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01541423
First received: February 16, 2012
Last updated: October 20, 2016
Last verified: October 2016
  Purpose
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
Hereditary Angioedema (HAE)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Incidence of adverse drug reactions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incidence of thrombotic/thromboembolic events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Occurrence of pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 83
Study Start Date: March 2012
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541423

Locations
Belgium
Universitair Ziekenhuis Antwerpen (UZA)
Antwerp, Edegem, Belgium, 2650
Clinic St-Luc University Hospital
Brussels, Belgium
France
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
Germany
Allergie-Centrum-Charite
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
Italy
Ospedale Luigi Sacco
Milano, Italy, 20157
Azienda Ospedaliera "V. Cervello"
Palermo, Italy, 90146
Spain
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
Shire
Investigators
Study Director: Irmgard Andersen, MD, FFPM Shire
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01541423     History of Changes
Other Study ID Numbers: 0624-401  SHP616-401 
Study First Received: February 16, 2012
Last Updated: October 20, 2016
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Italy: The Italian Medicines Agency
United Kingdom: National Health Service
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on December 06, 2016