A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema
This study is currently recruiting participants.
Verified May 2013 by ViroPharma
Sponsor:
ViroPharma
Information provided by (Responsible Party):
ViroPharma
ClinicalTrials.gov Identifier:
NCT01541423
First received: February 16, 2012
Last updated: May 2, 2013
Last verified: May 2013
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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 ViroPharma:
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
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 | |
| ViroPharma Investigational Site | Recruiting |
| Angers, France | |
| Germany | |
| ViroPharma Investigational Site | Recruiting |
| Berlin, Germany | |
| ViroPharma Investigational Site | Recruiting |
| Essen, Germany | |
| ViroPharma Investigational Site | Recruiting |
| Frankfurt, Germany | |
| ViroPharma Investigational Site | Recruiting |
| Mainz, Germany | |
| ViroPharma Investigational Site | Recruiting |
| Munich, Germany | |
| Spain | |
| ViroPharma Investigational Site | Recruiting |
| Valencia, Spain | |
| United Kingdom | |
| ViroPharma Investigational Site | Recruiting |
| London, United Kingdom | |
Sponsors and Collaborators
ViroPharma
Investigators
| Study Director: | Jennifer Schranz, MD, FRCP(C) | ViroPharma |
More Information
No publications provided
| Responsible Party: | ViroPharma |
| ClinicalTrials.gov Identifier: | NCT01541423 History of Changes |
| Other Study ID Numbers: | 0624-401 |
| Study First Received: | February 16, 2012 |
| Last Updated: | May 2, 2013 |
| 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 Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular |
Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 16, 2013