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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01541423
First received: February 16, 2012
Last updated: January 25, 2016
Last verified: January 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

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 ]

Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
  Eligibility

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
Investigational Site
Antwerp, Belgium
Investigational Site
Brussels, Belgium
France
Investigational Site
Angers, France
Investigational Site
Bondy, France
Investigational Site
Lille, France
Investigational Site
Nancy, France
Investigational Site
Paris, France
Germany
Investigational Site
Berlin, Germany
Investigational Site
Essen, Germany
Investigational Site
Frankfurt, Germany
Investigational Site
Mainz, Germany
Investigational Site
Munich, Germany
Investigational Site
Mörfelden-Walldorf, Germany
Italy
Investigational Site
Milano, Italy
Investigational Site
Palermo, Italy
Spain
Investigational Site
Logrono, Spain
Investigational Site
Madrid, Spain
United Kingdom
Investigational Site
London, United Kingdom
Investigational Site
Sheffield, United Kingdom
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: January 25, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Belgium: Federal Agency for Medicinal Products and Health Products
United Kingdom: National Health Service
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

ClinicalTrials.gov processed this record on May 02, 2016