Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)
Icatibant Outcome Survey (IOS) Registry
1 other identifier
observational
1,761
13 countries
72
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2009
Longer than P75 for all trials
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2009
CompletedFirst Submitted
Initial submission to the registry
December 17, 2009
CompletedFirst Posted
Study publicly available on registry
December 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedOctober 28, 2024
October 1, 2024
14.9 years
December 17, 2009
October 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (22)
Incidence of Cardiac Ischemia Events in Participants Predisposed to Cardiac Ischemia Events With Concomitant Firazyr (Icatibant) Administration
Incidence of cardiac ischemia events in participants predisposed to cardiac ischemia events with concomitant Firazyr (Icatibant) administration will be assessed.
From enrollment through study participation (Approximately 13 years)
Incidence of Hypotension for Firazyr (Icatibant)
Incidence of hypotension for Firazyr (Icatibant) will be assessed.
From enrollment through study participation (Approximately 13 years)
Incidence of Swelling of Mucous Membranes for Firazyr (Icatibant)
Incidence of swelling of mucous membranes for Firazyr (Icatibant) will be assessed.
From enrollment through study participation (Approximately 13 years)
Incidence of Bronchoconstriction for Firazyr (Icatibant)
Incidence of bronchoconstriction for Firazyr (Icatibant) will be assessed.
From enrollment through study participation (Approximately 13 years)
Incidence of Aggravation of Pain for Firazyr (Icatibant)
Incidence of aggravation of pain for Firazyr (Icatibant) will be assessed.
From enrollment through study participation (Approximately 13 years)
Sexual Hormones Level Measurements- Tanner Staging for Firazyr (Icatibant)
Effects on sexual maturation in pubertal adolescents will be measured using Tanner staging (pubic hair stage and genital breast stage) for Firazyr (Icatibant).
From enrollment through study participation (Approximately 13 years)
Time to Complete Resolution of the Firazyr (Icatibant)-Treated Laryngeal Attacks
Time to complete resolution of the laryngeal attacks will be assessed. It is defined as the time between the first injection of treatment and the complete resolution of all symptoms.
From enrollment through study participation (Approximately 13 years)
Incidence of Adverse Events (AE) Related to Firazyr (Icatibant)-Treated Laryngeal Attacks
An AE is defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in the registry, whether or not considered product-related. This includes an exacerbation of a pre-existing condition.
From enrollment through study participation (Approximately 13 years)
Incidence of Adverse Drug Reactions (ADR) for Firazyr (Icatibant)
An ADR is a response to a medicinal product that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, and treatment of disease or for the restoration, correction, or modification of physiological function.
From enrollment through study participation (Approximately 13 years)
Incidence of Serious Adverse Events (SAE) for Firazyr (Icatibant)
An AE or ADR that meets 1 or more of the following criteria or outcomes is classified as an SAE whether considered to be related to the pharmaceutical product or not: death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; important medical events.
From enrollment through study participation (Approximately 13 years)
Incidence of Pregnancy and Lactation Events During Firazyr (Icatibant) Exposure
The incidence of pregnancy or lactation events coinciding with exposure to Firazyr (Icatibant) will be summarized by angioedema treatment and subgroup.
From enrollment through study participation (Approximately 13 years)
Incidence of Adverse Events (AE) for Cinryze (C1 Inhibitor [Human])
An AE is defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in the registry, whether or not considered product-related. This includes an exacerbation of a pre-existing condition.
From enrollment through study participation (Approximately 13 years)
Incidence of Adverse Drug Reactions (ADR) for Cinryze (C1 Inhibitor [Human])
An ADR is a response to a medicinal product that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, and treatment of disease or for the restoration, correction, or modification of physiological function.
From enrollment through study participation (Approximately 13 years)
Incidence of Serious Adverse Events (SAE) for Cinryze (C1 Inhibitor [Human])
An AE or ADR that meets 1 or more of the following criteria or outcomes is classified as an SAE whether considered to be related to the pharmaceutical product or not: death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; important medical events.
From enrollment through study participation (Approximately 13 years)
Incidence of Thrombotic or Thromboembolic Events for Cinryze (C1 Inhibitor [Human])
Thrombotic or thromboembolic events will be reported as SAEs and will include, but are not limited to, established diagnoses of any of the following: renal allograft arterial or venous thrombosis; deep vein thrombosis; myocardial infarction; pulmonary embolism; Ischemic cerebrovascular accident (stroke)- cerebrovascular accident exclusive of cerebrovascular hemorrhage (subarachnoid or subdural hemorrhage); any large vessel thrombosis; thrombophlebitis; catheter-related thrombotic events (including clotted dialysis access grafts) will be assessed.
From enrollment through study participation (Approximately 13 years)
Incidence of Pregnancy and Lactation Events During Cinryze (C1 Inhibitor [Human]) Exposure
The incidence of pregnancy or lactation events coinciding with exposure to Cinryze (C1 inhibitor \[human\]) will be summarized by angioedema treatment and subgroup.
From enrollment through study participation (Approximately 13 years)
Drug Exposure Data for Cinryze (C1 Inhibitor [Human])
Drug exposure data for Cinryze (C1 inhibitor \[human\]) for prophylaxis, pre-procedural, and acute treatments will be reported.
From enrollment through study participation (Approximately 13 years)
Frequency of Hereditary Angioedema (HAE) Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Frequency of HAE attacks in participants treated with Cinryze (C1 inhibitor \[human\]) will be assessed.
From enrollment through study participation (Approximately 13 years)
Severity of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Severity of HAE attacks in participants treated with Cinryze (C1 inhibitor \[human\]) will be assessed.
From enrollment through study participation (Approximately 13 years)
Anatomic Location of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Anatomic location of HAE attacks in participants treated with Cinryze (C1 inhibitor \[human\]) will be assessed.
From enrollment through study participation (Approximately 13 years)
Outcome of Severe or Laryngeal Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
Outcome of severe or laryngeal HAE attacks in participants treated with Cinryze (C1 inhibitor \[human\]) will be assessed.
From enrollment through study participation (Approximately 13 years)
Outcome of Hereditary Angioedema Attacks for Treatment With Cinryze (C1 Inhibitor [Human])
Outcome of HAE attacks for treatment with Cinryze (C1 inhibitor \[human\]) which was initiated more than 4 hours after onset of the attack will be reported.
From enrollment through study participation (Approximately 13 years)
Secondary Outcomes (4)
Time to Treatment For Attack
From enrollment through study participation (Approximately 13 years)
Time to Complete Resolution of Attack
From enrollment through study participation (Approximately 13 years)
Total Duration of Attack
From enrollment through study participation (Approximately 13 years)
Hereditary Angioedema-Treated Attacks
From enrollment through study participation (Approximately 13 years)
Study Arms (1)
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.
Eligibility Criteria
Participants with Type I or II HAE, and, where applicable, with angiotensin-converting enzyme inhibitor (ACE-I)-induced angioedema, non-histaminergic idiopathic angioedema, or acquired angioedema, irrespective of treatment and/or other treatments and also participants who have taken at least 1 dose of Firazyr (Icatibant) or Cinryze (C1 inhibitor \[human\]) will be included in this study.
You may qualify if:
- 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.
- 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.
- At sites only participating in the drug registry, participants must have taken at least 1 dose of Firazyr (Icatibant) or Cinryze (C1 inhibitor \[human\]).
- Enrolled participants in Germany taking Firazyr (Icatibant) or Cinryze (C1 inhibitor \[human\]) will only use the respective product in accordance with the product label.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
- Takeda Development Center Americas, Inc.collaborator
Study Sites (74)
Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Medizinische Universität Graz
Graz, 8036, Austria
Faculdade de Medicina Do ABC
Santo André, São Paulo, 09060-870, Brazil
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
Odense Universitetshospital
Odense, DK-5000, Denmark
Hopital de Hautepierre
Strasbourg, Bas-Rhin, 67098, France
Hopital Cote de Nacre
Caen, Calvados, 14033, France
Hopital Purpan
Toulouse, Haute-Garonne, 31059, France
CHU Angers
Angers, 49933, France
Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin
Bordeaux, 33076, France
CHU La Cavale Blanche
Brest, 29609, France
CHU de GRENOBLE
Grenoble, 38043, France
Centre Hospitalier Le Mans
Le Mans, 72037, France
CHRU Lille
Lille, 59037, France
Groupement Hospitalier Edouard Herriot
Lyon, 69003, France
CHU Montpellier - Hôpital St Eloi
Montpellier, 34295, France
CHU de Nancy-Hopital Brabois Adulte
Nancy, 54035, France
Hôtel Dieu - Nantes
Nantes, 44093, France
CHU de Nice Archet I
Nice, 6202, France
Centre Hospitalier Georges Renon
Niort, 79021, France
Hôtel Dieu de Paris Hospital
Paris, 75001, France
Hôpital Saint Antoine
Paris, 75571, France
Hopital Cochin
Paris, 75679, France
CHU de Reims
Reims, 51000, France
Centre Hospitalier Universitaire de Saint Etienne
Saint-Etienne, 42100, France
Hals-Nasen-Ohrenklinik und Poliklinik
München, Bavaria, 81675, Germany
Klinikum der Johann-Wolfgang Goethe-Universitat
Frankfurt am Main, Hesse, 60590, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45122, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, 55101, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, 1307, Germany
Charité - Universitätsmedizin Berlin
Berlin, 12203, Germany
Hämophilie Zentrum Rhein Main GmbH
Mörfelden-Walldorf, 64546, Germany
Universitätsklinikum Ulm
Ulm, 89075, Germany
Navy Hospital of Athens
Athens, Attica, 11521, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 56429, Greece
St James's Hospital
Dublin, Ireland
Bnai Zion Medical Center
Haifa, 31048, Israel
Rabin Medical Center - PPDS
Petah Tikva, 49100, Israel
Sheba Medical Center - PPDS
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, 64239, Israel
AO Ospedale Policlinico Consorziale Di Bari
Bari, Apulia, 70124, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Apulia, 70124, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, 80131, Italy
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco
Milan, Lombardy, 20157, Italy
Presidio Policlinico Di Monserrato
Monserrato, Sardinia, 9042, Italy
Universita degli Studi di Padova
Padua, 35128, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
Palermo, 90146, Italy
CHUS - H. Clinico U. de Santiago
Santiago de Compostela, A Coruña, 15706, Spain
Hospital de La Marina Baixa
Villajoyosa, Alicante, 03570, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907, Spain
Hospital Universitario Vall d'Hebrón - PPDS
Barcelona, 8035, Spain
Hospital Cruz Roja Española de Gijón
Gijón, 33202, Spain
Hospital Universitario de Jaen
Jaén, 23007, Spain
Hospital de Santa Maria
Lleida, 25198, Spain
Centro de Alta Resolución de Procesos Asistenciales (C.A.R.P.A.)
Logroño, 26006, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46009, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, 36204, Spain
Länssjukhuset Ryhov
Jönköping, SE-55185, Sweden
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Frimley Park Hospital
Frimley, Surrey, GU16 7UJ, United Kingdom
St James University Hospital
Leeds, York, LS9 7TF, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
University Hospital of Wales - PPDS
Cardiff, CF14 4XW, United Kingdom
The Royal London Hospital
London, E1 2ES, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Manchester Royal Infirmary - PPDS
Manchester, M13 9WL, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Related Publications (10)
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.
PMID: 35861129DERIVEDGuilarte 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.
PMID: 34965883DERIVEDLonghurst 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.
PMID: 30127805DERIVEDCaballero 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.
PMID: 29599966DERIVEDAberer 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.
PMID: 28690642DERIVEDZanichelli 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.
PMID: 27742086DERIVEDLonghurst 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.
PMID: 27116379DERIVEDLonghurst 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.
PMID: 26314822DERIVEDHernandez 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.
PMID: 26112099DERIVEDMaurer 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.
PMID: 25198193DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda Development Center Americas
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2009
First Posted
December 18, 2009
Study Start
July 10, 2009
Primary Completion
May 31, 2024
Study Completion
May 31, 2024
Last Updated
October 28, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.