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

NCT01541423 | Completed

• 2 other identifiers: 0624-401SHP616-401
• Study Type: observational
• Target: 83
• Locations: 6 countries
• Sites: 20

Brief Summary

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.

Conditions

Hereditary Angioedema (HAE)

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse drug reactions

  12 months

• Incidence of thrombotic/thromboembolic events

  12 months

• Occurrence of pregnancy

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• All patients must not:
• Be receiving CINRYZE in an investigational study
• Be receiving another HAE therapy as part of a clinical trial

Sponsors & Collaborators

• Shire: lead

Study Sites (20)

Universitair Ziekenhuis Antwerpen (UZA)

Antwerp, Edegem, 2650, Belgium

Location

Clinic St-Luc University Hospital

Brussels, Belgium

Location

CHU d'Angers

Angers, 49033, France

Location

Hôpital Claude-Huriez

Lille, 59037, France

Location

Immunologie Clinique et Allergologie

Nancy, 54500, France

Location

Hôpital Saint Antoine

Paris, 75571, France

Location

Université Paris Descartes

Paris, 75679, France

Location

Allergie-Centrum-Charite

Berlin, 10117, Germany

Location

Universitätsklinik Essen

Essen, 45122, Germany

Location

Johann Wolfgang Goethe Universität

Frankfurt, 60590, Germany

Location

Universität-Hautklinik Mainz

Mainz, 55131, Germany

Location

Hämophilie-Zentrum Rhein Main

Mörfelden-Walldorf, D-64546, Germany

Location

Klinikum rechts der Isar der technischen Universität München

München, 81675, Germany

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Azienda Ospedaliera "V. Cervello"

Palermo, 90146, Italy

Location

C.A.R San Pedro

Logroño, 26003, Spain

Location

Hospital General Universitario

Madrid, 28007, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Barts and the London NHS Trust

London, E1 2ES, United Kingdom

Location

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

Related Links

• To obtain more information on the study, click here/on this link.

MeSH Terms

Conditions

Angioedemas, Hereditary

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: March 1, 2012
• Study Start: May 11, 2012
• Primary Completion: September 25, 2016
• Study Completion: September 25, 2016
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

DE (6); ES (3); BE (2); GB (2); IT (2); FR (5)