A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
Study Details
Study Description
Brief Summary
The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1. Micafungin
|
Drug: micafungin (Mycamine)
Intravenous
Other Names:
|
Active Comparator: 2. Itraconazole
|
Drug: itraconazole
oral
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Treatment success rate (fungal breakthrough rate) [At the end of the study]
Secondary Outcome Measures
- Incidence of proven or probable invasive fungal infection [Throughout the study period]
- The usage rate of systemic antifungal agents [During 4 weeks after the administration]
- Time to treatment failure [During the study period]
- Assessment of Adverse events, Laboratory examinations and vital signs evaluation [Throughout the study period]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:
-
Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant
-
Any patient undergoing an allogeneic hematopoietic stem cell transplant
Exclusion Criteria:
-
Patients with moderate or severe liver disease, as defined by:
-
AST or ALT greater than 5 times upper limit of normal (ULN), OR;
-
Total bilirubin greater than 2.5 times ULN
-
Patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fuzhou | Fujian | China | ||
2 | Wuhan | Hubei | China | ||
3 | Chengdu | Sichuan | China | ||
4 | Hangzhou | Zhejiang | China | ||
5 | Jiangsu | China | |||
6 | Nanning | China | |||
7 | Peking | China | |||
8 | Shanghai | China | |||
9 | Tianjin | China | |||
10 | Xian | China |
Sponsors and Collaborators
- Astellas Pharma Inc
Investigators
- Study Chair: Use Central Contact, Astellas Pharma Inc
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MCFGCN02-0