Posaconazole prophylaxis during antithymocyte gloulin (ATG) treatment for hypoplastic myelodysplastic syndrome (hMDS)/ aplastic anemia (AA) patients
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0003679
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
? An adult patient diagnosed with aplastic anemia or hypoplastic myelodysplastic syndrome is treated with antithymocyte globulin.
? Those who can express their willingness to participate in clinical trials.
? Adult patients aged more than 18 and under 75 years old.
? Person without corrected QT interval(the time between the start of the Q wave and the end of the T wave) prolongation in electrocardiogram.
? Those who have no problem with each organ function and meet the criteria below:
A. Serum creatinine = 2.0 times upper limit of normal
B. Serum bilirubin = 1.5 times upper limit of normal
C. Aspartate transaminase and alanine transaminase = 2.0 times upper limit of normal
? Patients suspected of fungal infection within 30 days of treatment of antithymocyte globulin
? Someone who was allergic to -triazols drug
? Someone with a history of other cancers in five years.
? Anti-cancer, radiation-treated person
? Current breastfeeding or pregnant female, all patients without birth control plan
? Patient with current active hepatitis B or C
? Patient who is positive for human immunodeficiency virus.
? A transplant patient
? Person with corrected QT interval(the time between the start of the Q wave and the end of the T wave) prolongation in baseline electrocardiogram or patients with Torsades de pointes.
? Patients taking the following medications - ergotamine alkaloid, cytochrome P450 3A4 substrate terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, or hydroxymethylglutaryl coenzyme A reductase inhibitor.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of fungal infection
- Secondary Outcome Measures
Name Time Method overall survival rate;mortality rate;incidence of fungal infection