Cresemba® in Treating Chinese Patients With IFD Caused by Aspergillus Species or Other Filamentous Fungi
- Registration Number
- NCT05630976
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 35
- proven, probable, or possible IFD caused by Aspergillus species, Mucorales species or other filamentous fungi
- body weight >40 kg at screening
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Isavuconazole Isavuconazole This is a single arm study, all enrolled participants will receive the study medication.
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) From Baseline to End of Study (EOS) and Prothrombin Time (PT)
- Secondary Outcome Measures
Name Time Method 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 Responses based on the investigators' assessment at EOT
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 Responses based on the investigators' assessment at EOT
Crude rate of success of the clinical response at EOT Day 42, and 84 Responses based on the investigators' assessment at EOT
Crude rate of success of the mycological response at EOT Day 42, and 84 Responses based on the investigators' assessment at EOT
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 Participants with TEAE leading to deaths 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
Trial Locations
- Locations (14)
Zibo Central Hospital
🇨🇳Zibo, Shandong, China
The First Affiliated Hospital of USTC, Anhui Province Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
ZhuJiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Jieyang People's Hospital
🇨🇳Jieyang, Guangdong, China
Henan provincial people's hospital
🇨🇳Zhengzhou, Henan, China
Liaocheng people's Hospital
🇨🇳Liaocheng, Shandong, China
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Institute of Hematology, Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Peking University People's Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, China
Jiading Central Hospital
🇨🇳Shanghai, China