FRIENDS-01:A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
88
3.0 µg/kg, subcutaneous injection, once a week. Afterwards, refer to the platelet count evaluated during the visit before the next dosing cycle: ① If the platelet count is less than 50×10\^9/L, increase by 1-2μg/kg once a week; ② If the platelet count is between 50-99×10\^9/L, increase by 1μg/kg once a week. According to platelet count and symptoms, investigators can adjust the dosage to the maximum dosage of 10μg/kg once a week.
25-50μg/kg, subcutaneous injection, once a day
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
The median number of days when the platelet count reaches 100×10^9/L or the absolute platelet count increases by 50×10^9/L
Time frame: through study completion, an average of 5 months
The median number of days for patients with baseline PLT counts less than 50×10^9/L and less than 75×10^9/L to achieve a PLT count of 100×10^9/L
Time frame: through study completion, an average of 5 months
The median number of days in which thrombocytopenia increases from Grade 3 or 4 to Grade 1 or 2
Time frame: through study completion, an average of 5 months
The average number of days when the platelet count reaches 100×10^9/L or the absolute platelet count increases by 50×10^9/L
Time frame: through study completion, an average of 5 months
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 1 week of treatment
Time frame: Within 1 weeks after receiving treatment
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 2 weeks of treatment
Time frame: Within 2 weeks after receiving treatment
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 3 weeks of treatment
Time frame: Within 3 weeks after receiving treatment
Proportion of patients with PLT reaching 100×10^9/L or absolute platelet count increase of 50×10^9/L after 4 weeks of treatment
Time frame: Within 4 weeks after receiving treatment
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Thrombocytopenia level in X+1 cycle of antitumor therapy
Time frame: through study completion, an average of 5 months
Proportion of bleeding patients
Time frame: through study completion, an average of 5 months
The incidence of platelet transfusion
Time frame: through study completion, an average of 5 months
The absolute increase in platelet count after the medication was discontinued
Time frame: through study completion, an average of 5 months
Effect of Romiplostim N01 on hemoglobin and leukocyte
Time frame: through study completion, an average of 5 months
Adverse events (evaluated using the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0), laboratory tests, vital signs, electrocardiograms, and physical examinations, etc
Time frame: through study completion, an average of 5 months
The incidence and severity of bleeding events ( being evaluated using the WHO Bleeding Scale) should be closely monitored for participants' drug allergies, cardiovascular adverse events, risk of thrombosis, and rhIL-11 related adverse events
Time frame: through study completion, an average of 5 months