To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors
The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）. Due to the late launch of Romiplostim N01 in China, the investigator also collected the information of Romiplostim N01 in the treatment of chemotherapy-induced thrombocytopenia according to the protocal of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）. This is a single-arm study to evaluate the safety and efficacy of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia （CIT）in tumors. These subjects have been treated with recombinant human thrombopoietin（rhTPO） or interleukin 11（IL-11） before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of Romiplostim N01 from week 1 to week 24, and observe incidence of adverse events during the treatment of Romiplostim N01. The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial. Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment and Eltrombopag in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of Romiplostim N01 treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The subjects will receive ropivacaine N01 treatment, with an initial dose of (2-3) µg/kg. When the dose is less than 250 µg, 250 µg (1 vial) can be administered (subcutaneously), once a week. The dose will be increased by (1) µg/kg each week, up to a maximum of 10 µg/kg, until the platelet count reaches ≥ 50 × 10\^9/L. If the platelet count returns to normal, the dose can be reduced according to the platelet level as appropriate.
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGEfficiency after 12 weeks of treatment with Romiplostim N01
The proportion of patients whose platelet count was ≥ 50 × 10\^9/L after 12 weeks (3 months) of treatment with Romiplostim N01.
Time frame: 12 weeks
Other efficacy evaluation after 12 weeks of treatment with Romiplostim N01
The proportion of patients whose platelet count was ≥ 30×10\^9/L or ≥ 100×10\^9/L after 12 weeks (3 months) of treatment with Romiplostim N01
Time frame: 12 weeks
Efficiency after 24 weeks of treatment with Romiplostim N01
The proportion of patients whose platelet count was ≥ 30×10\^9/L, ≥ 50×10\^9/L, or ≥ 100×10\^9/L after 24 weeks (6 months) of treatment with Romiplostim N01
Time frame: 24 weeks
Platelet counts at each visit point
Platelet counts after the treatment of Romiplostim N01 at each visit point
Time frame: 24 weeks
WHO bleeding scale at each visit point
Changes of the WHO bleeding scale after the treatment of Romiplostim N01 at each visit point. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.
Time frame: 24 weeks
Adverse events
Incidence, severity, and relationship of treatment emergent adverse events after Romiplostim N01 treatment
Time frame: 24 weeks
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