A Phase 4, Long-Term Observational Safety Study to Evaluate Immunogenicity and Hypersensitivity With Exposure to KALBITOR (Ecallantide) for the Treatment of Acute Attacks of HAE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 81
- 试验地点
- 38
- 主要终点
- Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR
研究概览
简要总结
The objective of this study is to evaluate the formation of antibodies, the occurence of allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients treated with KALBITOR (ecallantide).
详细描述
The objective of this study is to evaluate immunogenicity and hypersensitivity upon exposure to KALBITOR, in particular:
- Determine the rate of anaphylaxis and Type I hypersensitivity reactions upon exposure to KALBITOR.
- Determine the rate of seroconversion to anti-ecallantide antibodies upon exposure to KALBITOR.
- Determine the rate of adverse events related to disordered coagulation (hypercoagulability and hypocoagulability) upon exposure to KALBITOR.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients indicated per the approved product label for KALBITOR
- •Patient or guardian is able to understand and sign the informed consent form
- •Patient is willing and able to undergo a skin test procedure at screening (baseline)
排除标准
- •Patient contraindicated per the approved product label for KALBITOR
- •Patient confirmed pregnancy or active breastfeeding
- •Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study
研究组 & 干预措施
Patients naive to KALBITOR
HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study
干预措施: ecallantide (Drug)
Patients non- naive to KALBITOR
HAE patients that have been treated with KALBITOR prior to enrollment in the study
干预措施: ecallantide (Drug)
结局指标
主要结局
Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR
时间窗: 12 months after first treatment
Events of ecchymosis, hemorrhage, petechiae, spontaneous hemorrhage, hematoma, gastrointestinal bleeding, hemorrhagic stroke and any other term indicative of a bleeding event or increased tendency for bleeding were reviewed to determine the occurrence of hypocoagulability. Events of clotting, thrombosis, pulmonary embolism, vaso-occlusive stroke, myocardial infarction, and any other term indicative of a clotting event or increased risk of clotting were reviewed to determine the occurrence of hypercoagulability.
Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.
时间窗: 12 months after first treatment
Seroconversion is the development of detectable specific antibodies in the blood serum. Serum was tested for development of antibodies (irrespective of immunoglobulin class) against ecallantide at screening and at all safety evaluations. Positive results were to undergo a confirmatory test. Confirmed positive samples were further titered. Patients who developed an antibody response were evaluated for the development of neutralizing antibodies. Patients also had their serum analyzed for IgE-specific antibodies to ecallantide at screening and during safety evaluations. Positive results underwent a confirmatory test. Confirmed positive samples were further titered.
Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity
时间窗: 12 months after first treatment
Based on medical review of multiple preferred terms for treatment emergent adverse events (TEAEs) suggestive of Type 1 hypersensitivity; terms included adverse drug reaction, anaphylaxis, anaphylactic reaction, anaphylactoid reaction, hypersensitivity, erythema, flushing, hot flush, pharyngeal edema, laryngeal edema, pruritus, pruritus generalized, rash, rash erythematous, rhinitis allergic, rhinorrhea, throat irritation, urticaria, urticaria localized, dyspnea, and wheezing. Records of patients with any of these TEAE referred terms were reviewed further to assess potential hypersensitivity reactions, considering factors such as timing of TEAEs in relationship to dose (ie, occurred within 24 hours after start of KALBITOR treatment), accompanying symptoms, Investigator causality assessment (ie, reported as possibly, probably, or definitely related to study drug), and any other available clinical information. Anaphylaxis subset determined based on criteria established by the NIAID.
次要结局
- Overall Patient Response Assessment(within 4 hours post dose)