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Effect of Granulocyte-macrophage Stimulating Factor on Prevention and Treatment of Invasive Fungal Diseases in the Recipients of Allogeneic Stem Cell Transplantation: A Prospective Multicenter Randomized Phase 4 Trial
We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.
Details
| Lead sponsor | Xiamen Amoytop Biotech Co., Ltd. |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 206 |
| Start date | 2009-09 |
| Completion | 2013-06 |
Conditions
- Mycoses
Interventions
- rhGM-CSF group
- rhG-CSF+rhGM-CSF group
- rhG-CSF group
Primary outcomes
- Incidences of Invasive Fungal Diseases (IFD) — 100 day post transplant
The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation
Countries
China