Icatibant Outcome Survey (IOS) Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 1,761
- 试验地点
- 74
- 主要终点
- Incidence of Swelling of Mucous Membranes for Firazyr (Icatibant)
研究概览
简要总结
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.
详细描述
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]).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Swelling of Mucous Membranes for Firazyr (Icatibant)
时间窗: From enrollment through study participation (Approximately 13 years)
Incidence of swelling of mucous membranes for Firazyr (Icatibant) will be assessed.
Incidence of Adverse Events (AE) for Cinryze (C1 Inhibitor [Human])
时间窗: 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.
Drug Exposure Data for Cinryze (C1 Inhibitor [Human])
时间窗: 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.
Sexual Hormones Level Measurements- Tanner Staging for Firazyr (Icatibant)
时间窗: 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).
Incidence of Serious Adverse Events (SAE) for Firazyr (Icatibant)
时间窗: 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.
Incidence of Hypotension for Firazyr (Icatibant)
时间窗: From enrollment through study participation (Approximately 13 years)
Incidence of hypotension for Firazyr (Icatibant) will be assessed.
Incidence of Adverse Events (AE) Related to Firazyr (Icatibant)-Treated Laryngeal Attacks
时间窗: 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.
Incidence of Cardiac Ischemia Events in Participants Predisposed to Cardiac Ischemia Events With Concomitant Firazyr (Icatibant) Administration
时间窗: 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 Bronchoconstriction for Firazyr (Icatibant)
时间窗: From enrollment through study participation (Approximately 13 years)
Incidence of bronchoconstriction for Firazyr (Icatibant) will be assessed.
Time to Complete Resolution of the Firazyr (Icatibant)-Treated Laryngeal Attacks
时间窗: 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 Drug Reactions (ADR) for Firazyr (Icatibant)
时间窗: 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.
Severity of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
时间窗: From enrollment through study participation (Approximately 13 years)
Severity of HAE attacks in participants treated with Cinryze (C1 inhibitor \[human\]) will be assessed.
Anatomic Location of Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
时间窗: From enrollment through study participation (Approximately 13 years)
Anatomic location of HAE attacks in participants treated with Cinryze (C1 inhibitor \[human\]) will be assessed.
Outcome of Hereditary Angioedema Attacks for Treatment With Cinryze (C1 Inhibitor [Human])
时间窗: 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.
Incidence of Aggravation of Pain for Firazyr (Icatibant)
时间窗: From enrollment through study participation (Approximately 13 years)
Incidence of aggravation of pain for Firazyr (Icatibant) will be assessed.
Incidence of Pregnancy and Lactation Events During Firazyr (Icatibant) Exposure
时间窗: 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.
Incidence of Adverse Drug Reactions (ADR) for Cinryze (C1 Inhibitor [Human])
时间窗: 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.
Incidence of Serious Adverse Events (SAE) for Cinryze (C1 Inhibitor [Human])
时间窗: 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.
Frequency of Hereditary Angioedema (HAE) Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
时间窗: From enrollment through study participation (Approximately 13 years)
Frequency of HAE attacks in participants treated with Cinryze (C1 inhibitor \[human\]) will be assessed.
Incidence of Thrombotic or Thromboembolic Events for Cinryze (C1 Inhibitor [Human])
时间窗: 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.
Incidence of Pregnancy and Lactation Events During Cinryze (C1 Inhibitor [Human]) Exposure
时间窗: 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.
Outcome of Severe or Laryngeal Hereditary Angioedema Attacks in Participants Treated With Cinryze (C1 Inhibitor [Human])
时间窗: 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.
次要结局
- Time to Complete Resolution of Attack(From enrollment through study participation (Approximately 13 years))
- Time to Treatment For Attack(From enrollment through study participation (Approximately 13 years))
- Hereditary Angioedema-Treated Attacks(From enrollment through study participation (Approximately 13 years))
- Total Duration of Attack(From enrollment through study participation (Approximately 13 years))