To evaluate the hematological responses based on the response assessment criteria defined in this study (the 531-004 response assessment criteria) when AMG531 is subcutaneously (SC)-administered with 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
24
Subcutaneous administration of 0 to 20ug/kg for 6 months
NTT Medical center Tokyo
Shinagawa, Tokyo, Japan
Rate of achievement of complete response (CR) or partial response (PR)
Time frame: 27 weeks post-dose
Rate of achievement of CR or PR
Time frame: 14 weeks
Rate of 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.