CompletedPhase 2

Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients

South Korea20 participantsStarted 2018-04-20

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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:

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

What they're measuring

the Incidence of Proven/Probable/Possible Fungal Infection

Timeframe: during 4 weeks of posaconazole prophylaxis (i.e. upto 4 weeks)

Trial details

NCT IDNCT03318159

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-15

Results submitted2024-11-03

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