A Phase 2 interventional study of Avatrombopag in Chemotherapy-induced Thrombocytopenia and Avatrombopag, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 2, Interventional, and Treatment
To evaluate the efficacy and safety of Avatrombopag 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 Avatrombopag in China, the investigator also collected the information of Avatrombopag 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 Avatrombopag to treat chemotherapy-induced thrombocytopenia （CIT）in solid tumors. 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 Avatrombopag from week 1 to week 24, and observe incidence of adverse events during the treatment of Avatrombopag. 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 Herombopag treatment in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of Avatrombopag treatment.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's planned enrollment of 50 is close to the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.
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Exclusion Criteria:
50 enrolled subjects will be picked up to take Avatrombopag at the indicated dose.
Drug: Avatrombopag
The subjects will initiate treatment with 60 mg/d Avatrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 60 mg daily. Subjects whose platelet count ≤100×109/L，the Avatrombopag dose will maintain. If platelet count \>100×109/L for 2 weeks, the subjects need to reduce the dose of Avatrombopag 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 Avatrombopag to 20mg once every other day or lower frequency during the treatment period, Avatrombopag 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 Avatrombopag if the platelet is greater than 50×109/L.
Changes of the platelet counts after the treatment of Avatrombopag
The investigator will assess the changes of the platelet counts after the treatment of Avatrombopag 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 and week 24.
Time frame: 24 weeks
Incidence of adverse events after the treatment of Avatrombopag
The investigator will observe incidence of adverse events after the treatment of Avatrombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on.
Time frame: 24 weeks
Changes of concentration of TPO in peripheral blood
The investigator will observe the concentration of TPO in peripheral blood before and after the treatment of Avatrombopag, if necessary.
Time frame: 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 Avatrombopag, if necessary
Time frame: 24 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf
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Institute of Hematology & Blood Diseases Hospital, China