Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients (NCT03318159) | Clinical Trial Compass
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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the Incidence of Proven/Probable/Possible Fungal Infection
Timeframe: during 4 weeks of posaconazole prophylaxis (i.e. upto 4 weeks)