This study aimed to compare the efficacy and safety of enarodustat combined with cyclosporine versus cyclosporine monotherapy in the treatment of newly-diagnosed tansfusion-dependent non-severe aplastic anemia (TD-NSAA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Enarodustat 8mg qd
CsA 3-5mg/kg/d, trough concentration 100-200ng/ml
ORR
ORR=CRR+PRR
Time frame: 6-month
ORR
ORR=CRR+PRR
Time frame: 3-month, 12-month
RBC-TI rate
Proportion of patients who achieve red blood cell transfusion independence for 8 weeks or longer
Time frame: 3-month, 6-month, 12-month
hemoglobin response rate
Proportion of patients with hemoglobin response
Time frame: 3-month, 6-month, 12-month
AE rate
According to CTCAE, the proportion of patients with adverse events (AEs)
Time frame: through study completion, an average of 1 year
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