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

March 16, 2021 updated by: Shire

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse drug reactions
Time Frame: 12 months
12 months
Incidence of thrombotic/thromboembolic events
Time Frame: 12 months
12 months
Occurrence of pregnancy
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2012

Primary Completion (Actual)

September 25, 2016

Study Completion (Actual)

September 25, 2016

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (Estimate)

March 1, 2012

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0624-401
  • SHP616-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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