Status:
COMPLETED
A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Fungemia
Fungal Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 al...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00794703
Start Date
November 1 2008
End Date
November 1 2009
Last Update
March 28 2016
Active Locations (10)
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1
Fuzhou, Fujian, China
2
Wuhan, Hubei, China
3
Chengdu, Sichuan, China
4
Hangzhou, Zhejiang, China