Posaconazole prophylaxis during antithymocyte gloulin (ATG) treatment for hypoplastic myelodysplastic syndrome (hMDS)/ aplastic anemia (AA) patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0003679

Enrollment

Registered

2019-03-27

Start date

2018-08-10

Completion date

Unknown

Last updated

2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Among the patients with aplastic anemia or hypoplastic myelodysplastic syndrome, antithymocyte globulin treatment is targeted and the schedule for antithymocyte globulin treatment is as follows

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? 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

Exclusion criteria

Exclusion criteria: ? 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.

Design outcomes

Primary

Measure	Time frame
incidence of fungal infection	—

Secondary

Measure	Time frame
overall survival rate;mortality rate;incidence of fungal infection	—

Countries

Korea, Republic of

Contacts

Public ContactYoung-il Koh

Seoul National University Hospital

info@cisl.co.kr+82-2-2072-7217

Outcome results