Fungal Infections Clinical Trial
Official title:
A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine® vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant
Verified date | March 2016 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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
Status | Completed |
Enrollment | 288 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment success rate (fungal breakthrough rate) | At the end of the study | No | |
Secondary | Incidence of proven or probable invasive fungal infection | Throughout the study period | No | |
Secondary | The usage rate of systemic antifungal agents | During 4 weeks after the administration | No | |
Secondary | Time to treatment failure | During the study period | No | |
Secondary | Assessment of Adverse events, Laboratory examinations and vital signs evaluation | Throughout the study period | No |
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