To evaluate the hematological responses based on the response assessment criteria when AMG531 is subcutaneous (SC)-administered with anti-human thymocyte immunoglobulin (ATG) + ciclosporin A (CsA) therapy for 6 months in patients with aplastic anemia (AA) who were previously untreated with immunosuppressive therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Romiplostim SC. Initial dose is 10 ug/kg/. Maximum dose is 20 ug/kg. Original duration is 6 months from first administration but if investigator decide that the patient is needed more treatment, they move to extention period and take treatment up to 1 year.
Matsuyama Red Cross Hospital
Ehime, Japan
Achievement of complete response (CR) or partial response (PR)
Time frame: 27 weeks post-dose
Achievement of CR or PR
Time frame: Week 14
Achievement of CR
Time frame: Weeks 14 and 27
The time to CR or PR
Time frame: Each time point evaluated weekly until Week 27
Reduction or independence of platelet and/or erythrocyte transfusion
Time frame: Week 27
Change from baseline in platelet count (/µL)
Time frame: Each time point evaluated weekly until Week 27
Change from baseline in hemoglobin (Hb) concentration (g/dL)
Time frame: Each time point evaluated weekly until Week 27
Change from baseline in neutrophil count (/µL)
Time frame: Each time point evaluated weekly until Week 27
Change from baseline in reticulocyte count (/µL)
Time frame: Each time point evaluated weekly until Week 27
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