Efficacy and Safety of Recombinant human thrombopoietin in patients with severe aplastic anemia and very severe aplastic anemia, a randomized, double-blind, placebo-controlled, II phase, multi-center clinical research.
rhTPO
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
Zonghong Shao
Tianjin, Tianjin Municipality, China
Time to platelet transfusion independence in patients at 6 month
Time frame: 6 month
Time to patients achieve a platelet count 30×10^9/L, 50×10^9/L or100×10^9/L
Time frame: up to 1year
Overall response rate up to 1 year after Immunosupressive therapy.
Time frame: up to 1 year
Megakaryocyte, granulocyte and erythrocyte recovery in bone marrow up to 1 year after IST.
Time frame: up to 1 year
Time to red blood cell/platelet transfusion independence in patients up to 1 year after IST
Time frame: up to 1 year
Percentage of patients achieve red blood cell/platelet transfusion independence at 3, 6, 9 and 12 months after IST.
Time frame: up to 1 year
Intervals of red blood cell/platelet transfusion up to 1 year after IST.
Time frame: up to 1 year
The reticulocyte count of patients up to 1 year after IST.
Time frame: up to 1 year
Hospitalization days of patients.
Time frame: up to 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 1 year
Median hematopoietic response rate up to 1 year after IST.
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Time frame: up to 1 year