The purpose of this study is to explore the multiple-dose regimen of recombinant human thrombopoietin (rhTPO) injection for the treatment of thrombocytopenia in patients with chronic liver disease.
This is a multi-center, open label, phase Ib clinical study. The effectiveness of the multiple-dose regimen of recombinant human thrombopoietin injection in the treatment of thrombocytopenia in patients with chronic liver disease is mainly verified by evaluating the proportion of responders with platelet count in the first 8 days after treatment. Cohort 1 (n=18) : 50\*10\^9/L ≤ Baseline of PLT \< 75\*10\^9/L. Cohort 2 (n=36) : 30\*10\^9/L ≤ Baseline of PLT \< 50\*10\^9/L.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
recombinant human thrombopoietin: 15000 U subcutaneous injection once a day for 7 days
Peking University First Hospital
Beijing, Beijing Municipality, China
the proportion of responders with platelet count
Based on the results of routine blood tests, calculate the proportion of responders with platelet counts in the first 8 days after treatment
Time frame: Up to 8 days
the proportion of responders with platelet count
Based on the results of routine blood tests, calculate the proportion of responders with platelet counts during the study
Time frame: Up to 36 days
Platelet count
Based on the results of routine blood tests, calculate the change in platelet count from baseline at different visit times after treatment. Calculate the duration of alleviation of thrombocytopenia symptom relief to different levels (≥50×10\^9/L; ≥75×10\^9/L; ≥100×10\^9/L).
Time frame: Up to 36 days
Platelet peak
Based on the results of routine blood tests, observe the peak value of platelets and record the peak time after treatment.
Time frame: Up to 36 days
AE
All adverse events related to rhTPO observed through various tests (including blood routine, liver function, pregnancy test, electrocardiogram, etc.)
Time frame: Up to 36 days
Immunogenicity of rhTPO
Detect the presence of anti-rhTPO antibodies through the subject's blood sample
Time frame: At Day 1, Day 14, Day 36
Cmax
Detect the blood concentration of rhTPO by the subject's blood sample
Time frame: Up to 36 days
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AUC
Detect the blood concentration of rhTPO by the subject's blood sample, then calculate the area under the curve (AUC)
Time frame: Up to 36 days