Status:
COMPLETED
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
Lead Sponsor:
Xiamen Amoytop Biotech Co., Ltd.
Collaborating Sponsors:
Shanghai Jiao Tong University Affiliated First People's Hospital
Conditions:
Mycoses
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
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 Granu...
Detailed Description
From Sept 2009 to Dec 2012, we recruited consecutive patients with hematological diseases undergoing allogeneic stem cell transplantation at 5 institutions in China. Recipients between ages of 14 to 6...
Eligibility Criteria
Inclusion
- Age 14\~60 years old
- Allogenic hematological stem cell transplantation(HSCT) patients.
- Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or Alanine aminotransferase \< 2 upper limit of normal, and/or total bilirubin \< 2.5 upper limit of normal, creatinine \< upper limit of normal.
- Informed consent.
Exclusion
- Evidence of proven, probable or possible fungal infection at the time of enrollment.
- Patients were receiving anti-fungal treatment with proven SFI before transplantation.
- A history of hypersensitivity to G-CSF or GM-CSF.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT01232504
Start Date
September 1 2009
End Date
June 1 2013
Last Update
November 4 2014
Active Locations (5)
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1
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
3
Wuhan Tongji Hospital
Wuhan, Hubei, China, 430030
4
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China, 200080