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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00794703
Other study ID # MCFGCN02-0
Secondary ID
Status Completed
Phase Phase 3
First received November 19, 2008
Last updated March 25, 2016
Start date November 2008
Est. completion date November 2009

Study information

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

Clinical Trial 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


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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
micafungin (Mycamine)
Intravenous
itraconazole
oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

China, 

Outcome

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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