Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

 Hereditary Angioedema / Posted 2 months ago

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]).
  • Inclusion Criteria :
    • Ages Eligible for Study: Child, Adult, Older Adult
    • Sexes Eligible for Study: All
    • Accepts Healthy Volunteers: No
    • 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.
  • Exclusion Criteria :
    • 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.
  • Study end date : January 31, 2027
  • Wales-Based Study Contact : Tariq El-Shanawany, MBBS, MD, MRCPCH, MSc
Contact details

University Hospital of WalesCardiff,CF14 4XW  Show Phone Number ClinicalTransparency@takeda.com

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