Status:
COMPLETED
Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Aplastic Anemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To investigate the efficacy of posaconazole as prophylaxis antifungal agent in aplastic anemia / hypoplastic myelodysplastic syndrome (AA/hMDS) patients undergoing antithymocyte globulin (ATG) treatme...
Detailed Description
With compromised bone marrow function, patients with aplastic anemia (AA) and/and hypoplastic myelodysplastic syndrome (hMDS) are at an increased risk of invasive fungal infection. Moreover, the use o...
Eligibility Criteria
Inclusion
- willing and able to provide written informed consent for voluntary participation in the trial
- adult patients (≥18 years, \<75 years old)
- no QTc prolongation on initial ECG
- Adequate organ function for treatment as follows:
- A. Absolute neutrophil count \> 1.5 x 109/L B. Platelets \>100 x 109/L C. Serum creatinine ≤ 2.0 x ULN (upper limit of normal) D. Serum bilirubin ≤ 1.5 x ULN E. AST and ALT ≤ 2.0 x ULN
Exclusion
- those suspected of fungal infection within 30 days of ATG treatment
- those allergic to -triazoles
- those with history of malignancies within 5 years and/or concomitant malignancy other than AA/hMDS
- those with history of chemotherapy, radiotherapy and/or other immunosuppressants
- female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
- active HBV, HCV patients
- HIV positive patients
- those with history of receiving organ transplantation
Key Trial Info
Start Date :
April 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03318159
Start Date
April 20 2018
End Date
July 15 2023
Last Update
December 20 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea