To investigate the efficacy and safety of roprostin in the treatment of refractory AA after radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Enrolled patients were given roprostin (20 µg/kg subcutaneously once weekly) for at least 3 months, with discontinuation of roprostin for platelet counts ≥50 x 10\^9/L and continuation of roprostin for platelet counts \<50 x 10\^9/L. Responders were continued to 6 months. Responders continue to use the drug until 6 months.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
ORR
Overall response rate (ORR) is defined as the ratio of complete response (CR) + partial response (PR).CR is defined as a haemoglobin level ≥120 g/L, neutrophil count \>1.5 × 10\^9/L and platelet count \>150 × 10\^9/L in patients not receiving transfusion.PR is defined as not transfusion dependent (if previously dependent), or at least one cell lineage doubled or normalised or increased at baseline, or initial ANC \< 0.5 x 10\^9/L increased by at least 0.5 x 10\^9/L after treatment, or initial PLT \< 20 x 10\^9/L increased by at least 20 x 10\^9/L after treatment.
Time frame: 3 months, 6 months
CRR
Overall response rate (ORR) is defined as the ratio of complete response (CR) + partial response (PR).CR is defined as a haemoglobin level ≥120 g/L, neutrophil count \>1.5 × 10\^9/L and platelet count \>150 × 10\^9/L in patients not receiving transfusion.PR is defined as not transfusion dependent (if previously dependent), or at least one cell lineage doubled or normalised or increased at baseline, or initial ANC \< 0.5 x 10\^9/L increased by at least 0.5 x 10\^9/L after treatment, or initial PLT \< 20 x 10\^9/L increased by at least 20 x 10\^9/L after treatment.
Time frame: 3 months, 6months
safety events
Proportion and severity of adverse events in patients during the study period
Time frame: 3 months,6months
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