Phase 2
N=20
Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients
Aplastic Anemia · Myelodysplastic Syndromes · Fungal Infection
Bottom Line
View on ClinicalTrials.gov: NCT03318159 ↗Enrolled (actual)
20
Serious AEs
20.0%
Results posted
Dec 2024
Primary outcome: Primary: the Incidence of Proven/Probable/Possible Fungal Infection — 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Posaconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Incidence of Proven/Probable/Possible Fungal Infection |
20 | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Any Incidence of Proven/Probable/Possible Fungal Infection |
— | — |
Summary
To investigate the efficacy of posaconazole as prophylaxis antifungal agent in aplastic anemia / hypoplastic myelodysplastic syndrome (AA/hMDS) patients undergoing antithymocyte globulin (ATG) treatment
Eligibility Criteria
Inclusion Criteria
- willing and able to provide written informed consent for voluntary participation in the trial
- adult patients (≥18 years, 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03318159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.