To evaluate the efficacy and safety of Avatrombopag in patients with thrombocytopenia induced by targeted therapy and immunotherapy combination treatment, and provide evidence-based medication for the clinical use of Avatrombopag in patients with PC ≤50×109/L
This phase II trial is a single-arm, non-randomized and single-center clinical study. It is estimated that 30 patients who met the study criteria will be enrolled in PUMCH and treated with Avatrombopag. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment. Primary outcome measure is percentage of participants whose PLT reaches ≥75×109/L, or increases by ≥50×109/L or ≥100% from baseline at least once within 20 days of initial treatment. Secondary outcome measure:1)Number of days required for PLT to reach ≥50×109/L after treatment; 2)Number of days required for PLT to reach ≥75×109/L after treatment; 3)Percentage of subjects without platelet transfusion within 20 days of treatment; 4)Percentage of subjects without clinically relevant bleeding within 20 days of treatment. Study Type: Interventional. Masking: Open Label.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
* Participants meeting the eligibility criteria receive Avatrombopag treatment (orally, 60 mg/day), for a maximum course of 20 days. * Investigation product withdrawal: PLT ≥75×109/L or increases by at least 50×109/L from the lowest value after targeted therapy and immunotherapy combination treatment.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGPercentage of participants' PLT
Percentage of participants whose PLT reaches ≥75×109/L, or increases by ≥50×109/L or ≥100% from baseline at least once within 20 days of initial treatment.
Time frame: one year
Number of days required for PLT to reach ≥50×109/L after treatment;
Time frame: one year
Number of days required for PLT to reach ≥75×109/L after treatment;
Time frame: one year
Percentage of subjects without platelet transfusion within 20 days of treatment;
Time frame: one year
Percentage of subjects without clinically relevant bleeding within 20 days of treatment.
Time frame: one year
Haitao Haitao, Prof
CONTACT
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