Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT03318159
• Date of registration: 10/10/2017
• Prospective Registration: Yes
• Primary sponsor: Seoul National University Hospital
• Public title: Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients
• Scientific title: Open Label, Phase II Study Investigating the Efficacy of Posaconazole as Prophylaxis Antifungal Agent in Aplastic Anemia / Hypoplastic Myelodysplastic Syndrome Patients Undergoing Antithymocyte Globulin Treatment
• Date of first enrolment: April 20, 2018
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03318159
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion criteria

Inclusion Criteria:

1. willing and able to provide written informed consent for voluntary participation in
the trial

2. adult patients (=18 years, <75 years old)

3. no QTc prolongation on initial ECG

4. Adequate organ function for treatment as follows:

A. Absolute neutrophil count > 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:

1. those suspected of fungal infection within 30 days of ATG treatment

2. those allergic to -triazoles

3. those with history of malignancies within 5 years and/or concomitant malignancy other
than AA/hMDS

4. those with history of chemotherapy, radiotherapy and/or other immunosuppressants

5. 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

6. active HBV, HCV patients

7. HIV positive patients

8. those with history of receiving organ transplantation



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Myelodysplastic Syndromes

Aplastic Anemia

Fungal Infection

Intervention(s)

Drug: Posaconazole

Primary Outcome(s)

the incidence of proven/probable/possible fungal infection [Time Frame: during 4 weeks of posaconazole prophylaxis (i.e. upto 4 weeks)]

Secondary Outcome(s)

any incidence of proven/probable/possible fungal infection [Time Frame: through study completion, an average of 18 months]

overall survival [Time Frame: through study completion, an average of 18 months]

Secondary ID(s)

H-1706-207-866

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme LLC