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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Herombopag monotherapy | Experimental |
| |
| Herombopag is treated in combination with rhTPO(Recombinant human thrombopoietin) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPO-RA (Herombopag) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| During the correction period, the median time for platelet values to return to normal | Median time for platelet values to return to normal | up to 60 days |
| During the correction period, the Median time for platelet count to return to 75×109/L |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zong Hong, Professor | Contact | 13523586882 | fcczongh@zzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zong Hong, Professor | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
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| TPO-RA (Herombopag) and rhTPO(Recombinant human thrombopoietin) | Drug | 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. |
|
Median time for platelet count to return to 75×109/L
| 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 | 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 | 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 | 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. | 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 | 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 | up to 14 days |
| During the prophylaxis period, platelet counts are at their lowest. | During the prophylaxis period, platelet counts are at their lowest. | 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. | up to 14 days |
| Platelet value curve | Platelet value curve | up to 60 days |