Trial Information
Antifungal Effects of Recombinant Human Granulocyte Macrophage Colony Stimulating Factor in Patients After Allogeneic Hematopoietic Stem Cell Transplantation
Inclusion Criteria:
- Allogenic hematological stem cell transplantation(HSCT) patients.
- No serious damage to heart, liver and kidney function(TBIL≤34μmol/L, Cr≤120μmol/L, a
normal EF).
- Informed consent.
Exclusion Criteria:
- Patients were receiving anti-fungal treatment with proven SFI before transplantation.
- Allergic to rhGM-CSF or rhG-CSF.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Incidence of fungal infection after Allo-HSCT
Outcome Description:
Incidence of fungal infection during 100 days after Allo-HSCT.
Outcome Time Frame:
100 days
Safety Issue:
Yes
Principal Investigator
Chun Wang, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Shanghai First People's Hospital
Authority:
China: Ethics Committee
Study ID:
L-09-01
NCT ID:
NCT01232504
Start Date:
September 2009
Completion Date:
December 2011
Related Keywords:
- Fungal Infection After Allogeneic Stem Cell Transplantation
- Allo-HSCT
- rhGM-CSF
- Systemic fungal infection (SFI)
- Mycoses