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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01034969
Registration number
NCT01034969
Ethics application status
Date submitted
17/12/2009
Date registered
18/12/2009
Date last updated
28/09/2023
Titles & IDs
Public title
Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)
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Scientific title
Icatibant Outcome Survey (IOS) Registry
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Secondary ID [1]
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JE049-5134
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hereditary Angioedema (HAE)
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Cardiac Ischemia Events in Participants Predisposed to Cardiac Ischemia Events With Concomitant Firazyr (Icatibant) Administration
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Assessment method [1]
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Incidence of cardiac ischemia events in participants predisposed to cardiac ischemia events with concomitant Firazyr (Icatibant) administration will be assessed.
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Timepoint [1]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [2]
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Incidence of Hypotension for Firazyr (Icatibant)
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Assessment method [2]
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Incidence of hypotension for Firazyr (Icatibant) will be assessed.
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Timepoint [2]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [3]
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Incidence of Swelling of Mucous Membranes for Firazyr (Icatibant)
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Assessment method [3]
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Incidence of swelling of mucous membranes for Firazyr (Icatibant) will be assessed.
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Timepoint [3]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [4]
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Incidence of Bronchoconstriction for Firazyr (Icatibant)
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Assessment method [4]
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Incidence of bronchoconstriction for Firazyr (Icatibant) will be assessed.
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Timepoint [4]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [5]
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Incidence of Aggravation of Pain for Firazyr (Icatibant)
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Assessment method [5]
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Incidence of aggravation of pain for Firazyr (Icatibant) will be assessed.
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Timepoint [5]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [6]
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Sexual Hormones Level Measurements- Tanner Staging for Firazyr (Icatibant)
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Assessment method [6]
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Effects on sexual maturation in pubertal adolescents will be measured using Tanner staging (pubic hair stage and genital breast stage) for Firazyr (Icatibant).
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Timepoint [6]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [7]
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Time to Complete Resolution of the Firazyr (Icatibant)-Treated Laryngeal Attacks
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Assessment method [7]
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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.
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Timepoint [7]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [8]
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Incidence of Adverse Events (AE) Related to Firazyr (Icatibant)-Treated Laryngeal Attacks
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Assessment method [8]
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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.
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Timepoint [8]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [9]
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Incidence of Adverse Drug Reactions (ADR) for Firazyr (Icatibant)
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Assessment method [9]
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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.
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Timepoint [9]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [10]
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Incidence of Serious Adverse Events (SAE) for Firazyr (Icatibant)
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Assessment method [10]
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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.
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Timepoint [10]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [11]
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Incidence of Pregnancy and Lactation Events During Firazyr (Icatibant) Exposure
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Assessment method [11]
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The incidence of pregnancy or lactation events coinciding with exposure to Firazyr (Icatibant) will be summarized by angioedema treatment and subgroup.
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Timepoint [11]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [12]
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Incidence of Adverse Events (AE) for Cinryze (C1 Inhibitor [Human])
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Assessment method [12]
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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.
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Timepoint [12]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [13]
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Incidence of Adverse Drug Reactions (ADR) for Cinryze (C1 Inhibitor [Human])
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Assessment method [13]
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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.
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Timepoint [13]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [14]
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Incidence of Serious Adverse Events (SAE) for Cinryze (C1 Inhibitor [Human])
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Assessment method [14]
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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.
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Timepoint [14]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [15]
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Incidence of Thrombotic or Thromboembolic Events for Cinryze (C1 Inhibitor [Human])
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Assessment method [15]
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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.
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Timepoint [15]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [16]
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Incidence of Pregnancy and Lactation Events During Cinryze (C1 Inhibitor [Human]) Exposure
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Assessment method [16]
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The incidence of pregnancy or lactation events coinciding with exposure to Cinryze (C1 inhibitor [human]) will be summarized by angioedema treatment and subgroup.
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Timepoint [16]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [17]
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Drug Exposure Data for Cinryze (C1 Inhibitor [Human])
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Assessment method [17]
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Drug exposure data for Cinryze (C1 inhibitor [human]) for prophylaxis, pre-procedural, and acute treatments will be reported.
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Timepoint [17]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [18]
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Frequency of Hereditary Angioedema (HAE) Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
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Assessment method [18]
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Frequency of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.
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Timepoint [18]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [19]
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Severity of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
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Assessment method [19]
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Severity of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.
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Timepoint [19]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [20]
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Anatomic Location of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
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Assessment method [20]
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Anatomic location of HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.
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Timepoint [20]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [21]
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Outcome of Severe or Laryngeal Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
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Assessment method [21]
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Outcome of severe or laryngeal HAE attacks in participants treated with Cinryze (C1 inhibitor [human]) will be assessed.
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Timepoint [21]
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From enrollment through study participation (Approximately 13 years)
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Primary outcome [22]
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Outcome of Hereditary Angioedema Attacks for Treatment With Cinryze (C1 Inhibitor [Human])
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Assessment method [22]
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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.
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Timepoint [22]
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From enrollment through study participation (Approximately 13 years)
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Secondary outcome [1]
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Time to Treatment For Attack
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Assessment method [1]
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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.
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Timepoint [1]
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From enrollment through study participation (Approximately 13 years)
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Secondary outcome [2]
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Time to Complete Resolution of Attack
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Assessment method [2]
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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.
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Timepoint [2]
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From enrollment through study participation (Approximately 13 years)
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Secondary outcome [3]
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Total Duration of Attack
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Assessment method [3]
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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
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Timepoint [3]
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From enrollment through study participation (Approximately 13 years)
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Secondary outcome [4]
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Hereditary Angioedema-Treated Attacks
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Assessment method [4]
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The frequency, severity, and affected sites of HAE-treated attacks will be reported.
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Timepoint [4]
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From enrollment through study participation (Approximately 13 years)
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Eligibility
Key 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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/07/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/01/2027
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Actual
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Sample size
Target
3000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Graz
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Brazil
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São Paulo
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Czechia
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Brno
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Denmark
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State/province [4]
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Odense
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Country [5]
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France
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State/province [5]
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Bas-Rhin
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Country [6]
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France
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State/province [6]
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Calvados
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Country [7]
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France
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State/province [7]
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Haute-Garonne
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Country [8]
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France
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State/province [8]
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Angers Cedex 10
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Country [9]
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France
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State/province [9]
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Bordeaux
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Country [10]
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France
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State/province [10]
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Brest
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France
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State/province [11]
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Grenoble
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Country [12]
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France
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State/province [12]
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Le Mans cedex 9
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Country [13]
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France
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State/province [13]
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Lille
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Country [14]
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France
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State/province [14]
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Lyon
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Country [15]
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France
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State/province [15]
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Montpellier
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Country [16]
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France
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State/province [16]
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Nancy
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Country [17]
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France
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State/province [17]
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Nantes
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Country [18]
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France
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State/province [18]
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Nice
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Country [19]
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France
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State/province [19]
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Niort
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Country [20]
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France
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State/province [20]
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Paris
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Country [21]
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France
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State/province [21]
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Reims
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Country [22]
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France
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State/province [22]
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Saint-Etienne
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Country [23]
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Germany
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State/province [23]
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Bayern
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Country [24]
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Germany
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State/province [24]
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Hessen
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Germany
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State/province [25]
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Nordrhein-Westfalen
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Germany
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State/province [26]
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Rheinland-Pfalz
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Germany
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State/province [27]
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Sachsen
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Country [28]
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Germany
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State/province [28]
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Berlin
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Country [29]
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Germany
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State/province [29]
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Mörfelden-Walldorf
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Country [30]
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Germany
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State/province [30]
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Ulm
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Country [31]
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Greece
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State/province [31]
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Attiki
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Country [32]
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Greece
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State/province [32]
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Thessaloniki
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Country [33]
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Ireland
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State/province [33]
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Dublin 8
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Israel
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State/province [34]
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Haifa
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Country [35]
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Israel
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State/province [35]
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Petach Tikva
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Israel
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State/province [36]
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Ramat-Gan
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Israel
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Tel Aviv
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Italy
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State/province [38]
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Campania
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Italy
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State/province [39]
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Lombardia
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Italy
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State/province [40]
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Puglia
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Country [41]
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Italy
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State/province [41]
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Sardegna
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Country [42]
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Italy
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State/province [42]
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Padova
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Country [43]
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Italy
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State/province [43]
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Palermo
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Country [44]
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Spain
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State/province [44]
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A Coruña
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Gijon
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Spain
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Jaen
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Spain
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State/province [49]
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Lleida
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Spain
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Logrono
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Vigo
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Sweden
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State/province [55]
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Jönköping
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0
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United Kingdom
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State/province [56]
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Cambridgeshire
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0
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United Kingdom
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State/province [57]
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Oxfordshire
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Country [58]
0
0
United Kingdom
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State/province [58]
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Surrey
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Country [59]
0
0
United Kingdom
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State/province [59]
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York
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Country [60]
0
0
United Kingdom
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State/province [60]
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Birmingham
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Country [61]
0
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United Kingdom
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State/province [61]
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Cardiff
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Country [62]
0
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United Kingdom
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London
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Country [63]
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United Kingdom
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State/province [63]
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Manchester
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Country [64]
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United Kingdom
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State/province [64]
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Newcastle Upon Tyne
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Country [65]
0
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United Kingdom
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State/province [65]
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Shire
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Takeda Development Center Americas, Inc.
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01034969
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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Takeda Development Center Americas
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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Takeda Development Center Americas Contact
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Address
0
0
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Country
0
0
Query!
Phone
0
0
+1 866 842 5335
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Fax
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01034969
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