A SINGLE ARM, PROSPECTIVE, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF ISAVUCONAZOLE FOR PRIMARY TREATMENT OF CHINESE PATIENTS WITH INVASIVE FUNGAL DISEASE (IFD) CAUSED BY ASPERGILLUS SPECIES OR OTHER FILAMENTOUS FUNGI
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 70
- 试验地点
- 17
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC)
研究概览
简要总结
This study is a post-approval commitment study, and is designed to further evaluate the safety and efficacy of isavuconazole in a relatively larger Chinese population who will receive isavuconazole treatment in a post-marketing setting.
This is a single arm, prospective, multi-center study. This study is seeking Chinese patients with proven, probable or possible Invasive Fungal Disease (IFD) caused by Aspergillus species or other filamentous fungi. All the participants will receive isavuconazole treatment. The longest treatment duration in this study is 84 days (up to 180 days for participants diagnosed with IM).
The primary objective is to characterize the safety and tolerability of isavuconazole through observing the treatment emergent adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •proven, probable, or possible IFD caused by Aspergillus species, Mucorales species or other filamentous fungi
- •body weight >40 kg at screening
排除标准
- •either chronic aspergillosis, aspergilloma, or ABPA
- •Advanced HIV infection with CD4 count < 200 or acquired immunodeficiency syndrome-defining condition
- •people who are unlikely to survive 5 days or participants on mechanical ventilation
- •severe hepatic impairment (Child-Pugh Class C)
- •familial short QT syndrome
- •Concomitant use of efavirenz, ritonavir, etravirine, rifampicin/rifampin, rifabutin, nafcillin, ketoconazole, or St. John's Wort in the 5 days prior to first administration of study intervention
研究组 & 干预措施
Isavuconazole
This is a single arm study, all enrolled participants will receive the study medication.
干预措施: Isavuconazole (Drug)
结局指标
主要结局
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC)
时间窗: From Baseline to End of Study (EOS) and Prothrombin Time (PT)
次要结局
- Number of Participants with TEAE leading to deaths(Day 42, and 84)
- Number of Participants with TEAE leading to discontinuation of study intervention(Day 42, and 84)
- Crude rate success of the radiological responses at EOT(Day 42, and 84)
- Percentage of all-cause mortality following primary treatment with isavuconazole.(Day 42 and Day 84)
- Crude rate of overall response at EOT(Day 42, and 84)
- Crude rate of success of the clinical response at EOT(Day 42, and 84)
- Crude rate of success of the mycological response at EOT(Day 42, and 84)
- Number of Participants with TEAEs related to study intervention(Day 42, and 84)
- Number of Participants with TE Serious Adverse Event (SAEs) related to study intervention(Day 42, and 84)
- Number of all deaths(Day 42, and 84)
- Number of Participants with Clinical Laboratory Abnormalities(Day 42, and 84)
- Number of Participants with Vital Signs Abnormalities(Day 42, and 84)
- Number of Participants with Abnormal Electrocardiogram (ECG)(Day 42, and 84)
- Number of Participants with Abnormal Eye Examination.(Day 42, and 84)
- Isavuconazole plasma concentration(Day 3, 7, 14, and EOT visit)