Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

NCT ID: NCT01034969

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1761 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-10
• Study Completion Date: 2024-05-31

Brief Summary

The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor [human]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor [human]) in routine clinical practice and as a data source for post-marketing investigations.

Detailed Description

The Icatibant Outcome Survey (IOS) is a multicenter, prospective, observational study for participants treated with Firazyr (icatibant) and/or Cinryze (C1 inhibitor [human]) in countries where it is currently approved. The entry of participants in the Icatibant Outcome Survey (IOS) is at the discretion of the physician and the participant and is not a pre-requisite for prescribing Firazyr (icatibant) or Cinryze (C1 inhibitor [human]).

Conditions

Hereditary Angioedema (HAE)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with hereditary angioedema (HAE)

All participants with hereditary angioedema (HAE) who are administered Cinryze (C1 inhibitor \[human\]) or Firazyr (Icatibant) for the treatment or prevention of angioedema attacks in routine clinical practice will be included into the study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of at least 1 of the following:

• Hereditary angioedema (HAE) type I or II
• HAE with normal C1 inhibitor
• ACE-I-induced angioedema
• Non-histaminergic idiopathic angioedema
• Acquired angioedema.

2. Signed and dated written informed consent from the participant or, for participants aged less than(<)18 years (or as per local regulation, such as <16 years in the United Kingdom [UK]), parent and/or participants legally authorized representative (LAR), and assent of the minor where applicable.

3. At sites only participating in the drug registry, participants must have taken at least 1 dose of Firazyr (Icatibant) or Cinryze (C1 inhibitor [human]).

4. Enrolled participants in Germany taking Firazyr (Icatibant) or Cinryze (C1 inhibitor [human]) will only use the respective product in accordance with the product label.

Exclusion Criteria

1. Participants enrolled in clinical trials where the product is blinded or where the product under investigation is for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema.

2. Participants enrolled in another Shire-sponsored registry involving products for the treatment of HAE, ACE-I-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema. An exception applies to participants enrolled in the Shire lanadelumab ENABLE study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Development Center Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda Development Center Americas

Locations

Campbelltown Hospital

Campbelltown, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Medizinische Universität Graz

Graz, , Austria

Faculdade de Medicina Do ABC

Santo André, São Paulo, Brazil

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Odense Universitetshospital

Odense, , Denmark

Hopital de Hautepierre

Strasbourg, Bas-Rhin, France

Hopital Cote de Nacre

Caen, Calvados, France

Hopital Purpan

Toulouse, Haute-Garonne, France

CHU Angers

Angers, , France

Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

Bordeaux, , France

CHU La Cavale Blanche

Brest, , France

CHU de GRENOBLE

Grenoble, , France

Centre Hospitalier Le Mans

Le Mans, , France

CHRU Lille

Lille, , France

Groupement Hospitalier Edouard Herriot

Lyon, , France

CHU Montpellier - Hôpital St Eloi

Montpellier, , France

CHU de Nancy-Hopital Brabois Adulte

Nancy, , France

Hôtel Dieu - Nantes

Nantes, , France

CHU de Nice Archet I

Nice, , France

Centre Hospitalier Georges Renon

Niort, , France

Hôtel Dieu de Paris Hospital

Paris, , France

Hôpital Saint Antoine

Paris, , France

Hopital Cochin

Paris, , France

CHU de Reims

Reims, , France

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, , France

Hals-Nasen-Ohrenklinik und Poliklinik

München, Bavaria, Germany

Klinikum der Johann-Wolfgang Goethe-Universitat

Frankfurt am Main, Hesse, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Saxony, Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Hämophilie Zentrum Rhein Main GmbH

Mörfelden-Walldorf, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Navy Hospital of Athens

Athens, Attica, Greece

Papageorgiou General Hospital of Thessaloniki

Thessaloniki, , Greece

St James's Hospital

Dublin, , Ireland

Bnai Zion Medical Center

Haifa, , Israel

Rabin Medical Center - PPDS

Petah Tikva, , Israel

Sheba Medical Center - PPDS

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, , Israel

AO Ospedale Policlinico Consorziale Di Bari

Bari, Apulia, Italy

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Apulia, Italy

Azienda Ospedaliera Universitaria Federico II

Napoli, Campania, Italy

ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

Milan, Lombardy, Italy

Presidio Policlinico Di Monserrato

Monserrato, Sardinia, Italy

Universita degli Studi di Padova

Padua, , Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

Palermo, , Italy

CHUS - H. Clinico U. de Santiago

Santiago de Compostela, A Coruña, Spain

Hospital de La Marina Baixa

Villajoyosa, Alicante, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Vall d'Hebrón - PPDS

Barcelona, , Spain

Hospital Cruz Roja Española de Gijón

Gijón, , Spain

Hospital Universitario de Jaen

Jaén, , Spain

Hospital de Santa Maria

Lleida, , Spain

Centro de Alta Resolución de Procesos Asistenciales (C.A.R.P.A.)

Logroño, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Universitario La Paz - PPDS

Madrid, , Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, , Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Complejo Hospitalario Universitario de Vigo

Vigo, , Spain

Länssjukhuset Ryhov

Jönköping, , Sweden

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

Frimley Park Hospital

Frimley, Surrey, United Kingdom

St James University Hospital

Leeds, York, United Kingdom

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

University Hospital of Wales - PPDS

Cardiff, , United Kingdom

The Royal London Hospital

London, , United Kingdom

Royal Free Hospital

London, , United Kingdom

Manchester Royal Infirmary - PPDS

Manchester, , United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

Countries

Australia; Austria; Brazil; Czechia; Denmark; France; Germany; Greece; Ireland; Israel; Italy; Spain; Sweden; United Kingdom

References

Maurer M, Aberer W, Caballero T, Bouillet L, Grumach AS, Botha J, Andresen I, Longhurst HJ; IOS Study Group. The Icatibant Outcome Survey: 10 years of experience with icatibant for patients with hereditary angioedema. Clin Exp Allergy. 2022 Sep;52(9):1048-1058. doi: 10.1111/cea.14206. Epub 2022 Aug 7.

Reference Type: DERIVED

PMID: 35861129 (View on PubMed)

Guilarte M, Sala-Cunill A, Baeza ML, Cabanas R, Hernandez MD, Ibanez E, de Larramendi CH, Lleonart R, Lobera T, Marques L, de San Pedro BS, Botha J, Andresen I, Caballero T; IOS Study Group. Hereditary angioedema due to C1 inhibitor deficiency: real-world experience from the Icatibant Outcome Survey in Spain. Allergy Asthma Clin Immunol. 2021 Dec 29;17(1):137. doi: 10.1186/s13223-021-00641-3.

Reference Type: DERIVED

PMID: 34965883 (View on PubMed)

Longhurst HJ, Dempster J, Lorenzo L, Buckland M, Grigoriadou S, Symons C, Bethune C, Fabien V, Bangs C, Garcez T. Real-world outcomes in hereditary angioedema: first experience from the Icatibant Outcome Survey in the United Kingdom. Allergy Asthma Clin Immunol. 2018 Aug 6;14:28. doi: 10.1186/s13223-018-0253-x. eCollection 2018.

Reference Type: DERIVED

PMID: 30127805 (View on PubMed)

Caballero T, Zanichelli A, Aberer W, Maurer M, Longhurst HJ, Bouillet L, Andresen I; IOS Study Group. Effectiveness of icatibant for treatment of hereditary angioedema attacks is not affected by body weight: findings from the Icatibant Outcome Survey, a cohort observational study. Clin Transl Allergy. 2018 Mar 23;8:11. doi: 10.1186/s13601-018-0195-x. eCollection 2018.

Reference Type: DERIVED

PMID: 29599966 (View on PubMed)

Aberer W, Maurer M, Bouillet L, Zanichelli A, Caballero T, Longhurst HJ, Perrin A, Andresen I; IOS Study Group. Breakthrough attacks in patients with hereditary angioedema receiving long-term prophylaxis are responsive to icatibant: findings from the Icatibant Outcome Survey. Allergy Asthma Clin Immunol. 2017 Jul 5;13:31. doi: 10.1186/s13223-017-0203-z. eCollection 2017.

Reference Type: DERIVED

PMID: 28690642 (View on PubMed)

Zanichelli A, Longhurst HJ, Maurer M, Bouillet L, Aberer W, Fabien V, Andresen I, Caballero T; IOS Study Group. Misdiagnosis trends in patients with hereditary angioedema from the real-world clinical setting. Ann Allergy Asthma Immunol. 2016 Oct;117(4):394-398. doi: 10.1016/j.anai.2016.08.014.

Reference Type: DERIVED

PMID: 27742086 (View on PubMed)

Longhurst HJ, Aberer W, Bouillet L, Caballero T, Maurer M, Fabien V, Zanichelli A; IOS Study Group. The Icatibant Outcome Survey: treatment of laryngeal angioedema attacks. Eur J Emerg Med. 2016 Jun;23(3):224-7. doi: 10.1097/MEJ.0000000000000292.

Reference Type: DERIVED

PMID: 27116379 (View on PubMed)

Longhurst HJ, Aberer W, Bouillet L, Caballero T, Fabien V, Zanichelli A, Maurer M; IOS Investigators. Analysis of characteristics associated with reinjection of icatibant: Results from the icatibant outcome survey. Allergy Asthma Proc. 2015 Sep-Oct;36(5):399-406. doi: 10.2500/aap.2015.36.3892.

Reference Type: DERIVED

PMID: 26314822 (View on PubMed)

Hernandez Fernandez de Rojas D, Ibanez E, Longhurst H, Maurer M, Fabien V, Aberer W, Bouillet L, Zanichelli A, Caballero T; IOS Study Group. Treatment of HAE Attacks in the Icatibant Outcome Survey: An Analysis of Icatibant Self-Administration versus Administration by Health Care Professionals. Int Arch Allergy Immunol. 2015;167(1):21-8. doi: 10.1159/000430864. Epub 2015 Jun 25.

Reference Type: DERIVED

PMID: 26112099 (View on PubMed)

Maurer M, Longhurst HJ, Fabien V, Li HH, Lumry WR. Treatment of hereditary angioedema with icatibant: efficacy in clinical trials versus effectiveness in the real-world setting. Allergy Asthma Proc. 2014 Sep-Oct;35(5):377-81. doi: 10.2500/aap.2014.35.3780. Epub 2014 Aug 6.

Reference Type: DERIVED

PMID: 25198193 (View on PubMed)

Related Links

https://clinicaltrials.takeda.com/study-detail/5f6b5fcf4db2bf003ab4684f

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

Other Identifiers

JE049-5134

Identifier Type: -

Identifier Source: org_study_id