Status
Completed
Phase
Not applicable
Enrollment
1,761
Locations
74
Results
Not posted
Publications
10
Study 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.
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 \[human\]).
Interventions
No intervention details reported.
Timeline
First posted
Dec 18, 2009
Study start
Jul 10, 2009
Primary completion
May 31, 2024
Study completion
May 31, 2024
Results posted
Not reported
Registry updated
Oct 28, 2024
Outcomes
Incidence of Cardiac Ischemia Events in Participants Predisposed to Cardiac Ischemia Events With Concomitant Firazyr (Icatibant) Administration
Time frame · From enrollment through study participation (Approximately 13 years)
Incidence of cardiac ischemia events in participants predisposed to cardiac ischemia events with concomitant Firazyr (Icatibant) administration will be assessed.
Incidence of Hypotension for Firazyr (Icatibant)
Time frame · From enrollment through study participation (Approximately 13 years)
Incidence of hypotension for Firazyr (Icatibant) will be assessed.
Incidence of Swelling of Mucous Membranes for Firazyr (Icatibant)
Time frame · From enrollment through study participation (Approximately 13 years)
Incidence of swelling of mucous membranes for Firazyr (Icatibant) will be assessed.
Incidence of Bronchoconstriction for Firazyr (Icatibant)
Time frame · From enrollment through study participation (Approximately 13 years)
Incidence of bronchoconstriction for Firazyr (Icatibant) will be assessed.
Incidence of Aggravation of Pain for Firazyr (Icatibant)
Time frame · From enrollment through study participation (Approximately 13 years)
Incidence of aggravation of pain for Firazyr (Icatibant) will be assessed.
Sexual Hormones Level Measurements- Tanner Staging for Firazyr (Icatibant)
Time frame · From enrollment through study participation (Approximately 13 years)
Effects on sexual maturation in pubertal adolescents will be measured using Tanner staging (pubic hair stage and genital breast stage) for Firazyr (Icatibant).
Time to Complete Resolution of the Firazyr (Icatibant)-Treated Laryngeal Attacks
Time frame · From enrollment through study participation (Approximately 13 years)
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.
Incidence of Adverse Events (AE) Related to Firazyr (Icatibant)-Treated Laryngeal Attacks
Time frame · From enrollment through study participation (Approximately 13 years)
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.
Time to Treatment For Attack
Time frame · From enrollment through study participation (Approximately 13 years)
Time to treatment for attack will be assessed. It is defined as the time between the onset of the attack and the first injection of treatment.
Time to Complete Resolution of Attack
Time frame · From enrollment through study participation (Approximately 13 years)
Time to complete resolution of attack will be assessed. It is defined as the time between the first injection of treatment and the complete resolution of all symptoms.
Total Duration of Attack
Time frame · From enrollment through study participation (Approximately 13 years)
Total duration of attack will be assessed. It is defined as the time between the onset of the attack and the complete resolution of all symptoms
Hereditary Angioedema-Treated Attacks
Time frame · From enrollment through study participation (Approximately 13 years)
The frequency, severity, and affected sites of HAE-treated attacks will be reported.
Eligibility
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.
Study locations
Australia · Austria · Brazil · Czechia · Denmark · France · Germany · Greece · Ireland · Israel · Italy · Spain · Sweden · United Kingdom. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
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