A Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Cresemba to Evaluate Safety and Effectiveness in Patients With Invasive Aspergillosis or Invasive Mucormycosis in Korea.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Adverse event (AE) as safety evaluation
研究概览
简要总结
The purpose of this study is to observe safety and effectiveness of Cresemba in patients with invasive Aspergillosis or invasive Mucormycosis in Korea during the post-marketing surveillance period as required by Ministry of Food and Drug Safety (MFDS).
详细描述
In compliance with the Korean New Drug Re-Examination Guidelines, this study aims to collect further observational data on the safety and effectiveness of Cresemba for six years after authorization is obtained in at least 600 subjects under routine clinical practice. As the safety and effectiveness results obtained from the clinical development program of Cresemba are based on randomized trials using specific inclusion and exclusion criteria, data from the present post-authorization study where Cresemba is used in routine clinical practice per approved label is anticipated to provide important information on safety and effectiveness in a real-world population in Korea. This non-interventional study is designated as a PMS study and is a commitment to MFDS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •Patients aged 19 years or older
- •Patients with proven or suspected diagnosis of invasive Aspergillosis or invasive Mucormycosis.
- •Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Patients meeting any of the following criteria will not be included in the study:
- •Patients with known hypersensitivity to the active substance of Isavuconazole or to any of the excipients.
- •Patients are ineligible as determined by the investigator, such as those with familial short QT syndrome.
- •Patients administrating ketoconazole, high-dose ritonavir (>200 mg every 12 hours) or strong CYP3A4/5 inducers (e.g. rifampicin, carbamazepine, phenytoin) that cannot be discontinued before administration of Cresemba.
结局指标
主要结局
Adverse event (AE) as safety evaluation
时间窗: Starting from administration of first dose of Isavuconazole, will be continued through 28 days after from last administration of Isavuconazole.
Incidence of the adverse events from baseline in all patients who received at least one dose of Isavuconazole and completed safety follow up will be assessed. AEs will be analyzed by preferred term coding.
次要结局
- Effectiveness evaluation(From baseline to end of treatment or up to 12 weeks, whichever comes first.)