Investigating the efficacy and safety of rhTPO in combination with cyclosporine versus cyclosporine alone for the treatment of TD-NSAA
Investigating the efficacy and safety of rhTPO in combination with cyclosporine versus cyclosporine alone for the treatment of transfusion-dependent aplastic anaemia of the non-severe type
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
rhTPO
cyclosporine A
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
ORR
Overall Response Rate (ORR): meets the criteria for CR and PR.
Time frame: 3 months
CRR
Complete Response Rate (CRR):ANC\>1.5×10\^9/L,Hb\>100g/L,PLT\>100×10\^9/L;
Time frame: 3 months
ORR
Overall Response Rate (ORR): meets the criteria for CR and PR.
Time frame: 6 months
CRR
Complete Response Rate (CRR):ANC\>1.5×10\^9/L,Hb\>100g/L,PLT\>100×10\^9/L;
Time frame: 6 months
Time for platelet count to recover to ≥20 x 10^9/L with a 1-fold increase in absolute value
Time for platelet count to recover to ≥20 x 10\^9/L with a 1-fold increase in absolute
Time frame: through study completion, an average of 1 year
Proportion of patients with adverse events
safety event
Time frame: through study completion, an average of 1 year
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