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| Name | Class |
|---|---|
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| Tianjin Medical University Second Hospital | OTHER |
| Tianjin Third Central Hospital | OTHER |
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To evaluate the efficacy and safety of Herombopag to treat chemotherapy-induced thrombocytopenia in Solid Tumors
The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia(NCT04600960). Due to the late launch of Herombopag in China, the investigator also collected the information of Herombopag in the treatment of chemotherapy-induced thrombocytopenia according to the protocal of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia(NCT04600960).
This is a single-arm study to evaluate the safety and efficacy of Herombopag to treat chemotherapy-induced thrombocytopenia(CIT). These subjects have been treated with recombinant human thrombopoietin(rhTPO) or interleukin 11(IL-11) before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of Herombopag from week 1 to week 24, and observe incidence of adverse events during the treatment of Herombopag. The investigator will complete the 4 weeks safety visits(once a week),if the subjects end or withdraw from the clinical trial.
Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment and Eltrombopag or Avatrombopag treatment in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of Herombopag treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 subjects with chemotherapy-induced thrombocytopenia | Experimental | 50 enrolled subjects will be picked up to take Herombopag at the indicated dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herombopag | Drug | The subjects will initiate treatment with 7.5 mg/d Herombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 7.5 mg daily. Subjects whose platelet count ≤100×109/L,the Herombopag dose will maintain. If platelet count >100×109/L for 2 weeks, the subjects need to reduce the dose of Herombopag to the next lower dose or lower frequency. If subjects whose platelet count exceeds 100×109/L for 4 weeks,already have reduced the dose of Herombopag to 2.5mg once every other day or lower frequency during the treatment period, Herombopag can be stopped for observation, until platelet counts fall below 100×109/L. If the subjects do not need further chemotherapy or radiotherapy, the subjects can taper off Herombopag if the platelet is greater than 50×109/L. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the platelet counts after the treatment of Herombopag at week 12 | The investigator will assess the changes of the platelet counts after the treatment of Herombopag from week 1 to week 24,and calculate the proportion of subjects ≥ 30 × 10^9/L , 50 × 10^9/L and 100 × 10^9/L at week 12. | 12 weeks |
| Changes of the platelet counts after the treatment of Herombopag at week 24 | The investigator will assess the changes of the platelet counts after the treatment of Herombopag from week 1 to week 24,and calculate the proportion of subjects ≥ 30 × 10^9/L , 50 × 10^9/L and 100 × 10^9/L at week 24. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events after the treatment of Herombopag | The investigator will observe incidence of adverse events after the treatment of Herombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on. | 24 weeks |
| Changes of concentration of TPO in peripheral blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunfei Chen, MD | Contact | +8618502220788 | chenyunfei@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lei Zhang, MD | Chinese Academy of Medical Science and Blood Disease Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Science and Blood Disease Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.
12 months to 36 months after study completion.
Upon request to PI.
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| Tianjin People's Hospital |
| OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| The Second Affiliated Hospital of Kunming Medical University | OTHER |
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The investigator will observe the concentration of TPO in peripheral blood before and after the treatment of Herombopag, if necessary. |
| 24 weeks |
| Changes of concentration of TPO antibodies,anti-c-Mpl antibodies and TPO neutralizing antibodies in peripheral blood | The investigator will observe the concentration of antibodies in peripheral blood before and after the treatment of Herombopag, if necessary | 24 weeks |