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Firazyr® Patient Registry (Icatibant Outcome Survey - IOS) | Clinical Trials | Clareo Health

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Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

Icatibant Outcome Survey (IOS) Registry

NCT01034969•Shire

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 \[human\]).

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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.

Locations (74)

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

Key Dates

Start Date

July 10, 2009

Primary Completion Date

May 31, 2024

Completion Date

May 31, 2024

Last Updated

October 28, 2024

Enrollment

1,761

ACTUAL participants

Conditions

Hereditary Angioedema (HAE)

Donidalorsen Treatment in Children With Hereditary Angioedema

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Hereditary Angioedema (HAE)

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RECRUITINGPHASE3

A Study of Navenibart in Participants With Hereditary Angioedema

NCT06842823

Hereditary Angioedema (HAE)

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ACTIVE_NOT_RECRUITING

A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

NCT05469789

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

Inclusion Criteria

Exclusion Criteria

Donidalorsen Treatment in Children With Hereditary Angioedema

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A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)

Phase 3 Extension Study of ADX-324 in Participants With Hereditary Angioedema (HAE)

CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema

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