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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Shire
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01541423
First received: February 16, 2012
Last updated: March 20, 2014
Last verified: March 2014
  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: 125
Study Start Date: March 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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

Contacts
Contact: Danielle Tierens +32 2 747 09 71 protocol-0624-401@viropharma.com

Locations
France
Investigational Site Recruiting
Angers, France
Investigational Site Recruiting
Bondy, France
Investigational Site Recruiting
Lille, France
Investigational Site Recruiting
Nancy, France
Investigational Site Recruiting
Paris, France
Germany
Investigational Site Recruiting
Berlin, Germany
Investigational Site Recruiting
Essen, Germany
Investigational Site Recruiting
Frankfurt, Germany
Investigational Site Recruiting
Mainz, Germany
Investigational Site Recruiting
Munich, Germany
Investigational Site Recruiting
Mörfelden-Walldorf, Germany
Spain
Investigational Site Recruiting
Cadiz, Spain
Investigational Site Recruiting
Logrono, Spain
Investigational Site Recruiting
Madrid, Spain
Investigational Site Recruiting
Valencia, Spain
United Kingdom
Investigational Site Recruiting
London, United Kingdom
Sponsors and Collaborators
Shire
Investigators
Study Director: Jennifer Schranz, MD, FRCP(C) Shire
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01541423     History of Changes
Other Study ID Numbers: 0624-401
Study First Received: February 16, 2012
Last Updated: March 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: National Health Service
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
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 October 23, 2014