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Completed

NCT Number: NCT01034969

Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

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.

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Key information

Conditions

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Campbelltown Hospital, Campbelltown, New South Wales, Australia

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About this study

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]).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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.

  9. Incidence of Adverse Drug Reactions (ADR) for Firazyr (Icatibant)

    Time frame: From enrollment through study participation (Approximately 13 years)

    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.

  10. Incidence of Serious Adverse Events (SAE) for Firazyr (Icatibant)

    Time frame: From enrollment through study participation (Approximately 13 years)

    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.

  11. Incidence of Pregnancy and Lactation Events During Firazyr (Icatibant) Exposure

    Time frame: From enrollment through study participation (Approximately 13 years)

    The incidence of pregnancy or lactation events coinciding with exposure to Firazyr (Icatibant) will be summarized by angioedema treatment and subgroup.

  12. Incidence of Adverse Events (AE) for Cinryze (C1 Inhibitor [Human])

    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.

  13. Incidence of Adverse Drug Reactions (ADR) for Cinryze (C1 Inhibitor [Human])

    Time frame: From enrollment through study participation (Approximately 13 years)

    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.

  14. Incidence of Serious Adverse Events (SAE) for Cinryze (C1 Inhibitor [Human])

    Time frame: From enrollment through study participation (Approximately 13 years)

    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.

  15. Incidence of Thrombotic or Thromboembolic Events for Cinryze (C1 Inhibitor [Human])

    Time frame: From enrollment through study participation (Approximately 13 years)

    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.

  16. Incidence of Pregnancy and Lactation Events During Cinryze (C1 Inhibitor [Human]) Exposure

    Time frame: From enrollment through study participation (Approximately 13 years)

    The incidence of pregnancy or lactation events coinciding with exposure to Cinryze (C1 inhibitor [human]) will be summarized by angioedema treatment and subgroup.

  17. Drug Exposure Data for Cinryze (C1 Inhibitor [Human])

    Time frame: From enrollment through study participation (Approximately 13 years)

    Drug exposure data for Cinryze (C1 inhibitor [human]) for prophylaxis, pre-procedural, and acute treatments will be reported.

  18. Frequency of Hereditary Angioedema (HAE) Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])

    Time frame: From enrollment through study participation (Approximately 13 years)

    Frequency of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.

  19. Severity of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])

    Time frame: From enrollment through study participation (Approximately 13 years)

    Severity of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.

  20. Anatomic Location of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])

    Time frame: From enrollment through study participation (Approximately 13 years)

    Anatomic location of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.

  21. Outcome of Severe or Laryngeal Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])

    Time frame: From enrollment through study participation (Approximately 13 years)

    Outcome of severe or laryngeal HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.

  22. Outcome of Hereditary Angioedema Attacks for Treatment With Cinryze (C1 Inhibitor [Human])

    Time frame: From enrollment through study participation (Approximately 13 years)

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Collaborators

  • Takeda Development Center Americas, Inc.

Registry information

Official study title

Icatibant Outcome Survey (IOS) Registry

Important dates

Study start
2009
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2009
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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