The purpose of this study is to confirm the safety and efficacy of Herombopag in tumors-associated thrombocytopenia
CIT is one of the most common complications of tumor treatment, which is caused by the inhibition of anticancer chemotherapy drugs on megakaryocytes in bone marrow, resulting in platelet count lower than 100×109/L in peripheral blood, and is a common hematological toxic reaction in clinic. CIT leads to an increased risk of bleeding and transfusion, and severe CIT can cause intracranial bleeding and death. The use of platelet infusion is limited and ineffective in 25% of patients. rhIL-11 increases the incidence of cardiovascular events and rhTPO may produce immunogenicity. Currently, TPO-RA is recommended for the treatment of CIT by consensus guidelines at home and abroad. The study was designed to explore the safety and efficacy of Herombopag in the treatment of tumour-associated thrombocytopenia.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
During the correction period, subjects will receive a dose of Herombopag starting at 5-7.5mg once daily, orally for 14 days, subject to dosing adjustment (or discontinuation) depending on their platelet response or at the investigator's discretion. In the secondary prophylaxis phase, Herombopag 5mg once daily, starting 5 days before antineoplastic therapy and continuing for 10-14 days.
During the correction period, subjects will receive a combination of Herombopag and rhTPO, Herombopag starting at a recommended dose of 5mg once daily for 14 days. The recombinant human thrombopoietin dose is 300U/kg. bw/day or 15000U/day per person, once daily, for 14 consecutive days (or as determined by the investigator). In the secondary prophylaxis phase, Herombopag 5mg once daily, starting 5 days before antineoplastic therapy and continuing for 10-14 days.
During the correction period, the percentage of patients whose platelets returned to normal within 14 days
Percentage of patients whose platelets returned to normal within 14 days
Time frame: up to 14 days
During the correction period, the median time for platelet values to return to normal
Median time for platelet values to return to normal
Time frame: up to 60 days
During the correction period, the Median time for platelet count to return to 75×109/L
Median time for platelet count to return to 75×109/L
Time frame: up to 60 days
During the correction period, the median time for platelet count to return to 50×109/L
Median time for platelet count to return to 50×109/L
Time frame: up to 60 days
During the correction period, the percentage of patients whose platelets returned to75×109/L within 14 days
Percentage of patients whose platelets returned to75×109/L within 14 days
Time frame: up to 14 days
During the correction period, the percentage of patients whose platelets returned to 50×109/L within 14 days
Percentage of patients whose platelets returned to 50×109/L within 14 days
Time frame: up to 14 days
During the correction period, platelet infusion rate after initiation of Herombopag therapy.
During the correction period, platelet infusion rate after initiation of Herombopag therapy.
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Time frame: up to 14 days
During the prophylaxis period, the proportion of patients whose PLT<75×109/L
During the prophylaxis period, the proportion of patients whose PLT\<75×109/L
Time frame: up to 14 days
During the prophylaxis period, the proportion of patients whose PLT<50×109/L
During the prophylaxis period, the proportion of patients whose PLT\<50×109/L
Time frame: up to 14 days
During the prophylaxis period, platelet counts are at their lowest.
During the prophylaxis period, platelet counts are at their lowest.
Time frame: up to 14 days
During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.
During the prophylaxis period, platelet infusion rate after initiation of Herombopag therapy.
Time frame: up to 14 days
Platelet value curve
Platelet value curve
Time frame: up to 60 days