A Phase 4 interventional study of recombinant human thrombopoietin in Thrombocytopenia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Phase 4, Interventional, and Treatment
In this single-center, randomized, open-label, crossover, prospective clinical trial, a total of 120 AML patients who achieved remission will be randomized into two groups, of 60 cases in each group. Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle, patients received subcutaneous injection of rhTPO. At the control cycle, rhTPO therapy is not given.The safety of rhTPO is evaluated by the monitoring of liver and renal functions, blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO treatment are recorded during the study period.
In this single-center, randomized, open-label, crossover, prospective clinical trial, a total of 120 AML patients who achieved remission following induction chemotherapy will be recruited and randomized into two groups, of 60 cases in each group. For one group, the treatment cycle is in the first chemotherapy cycle and the control cycle is in the second one. For another group, the treatment cycle is in the second chemotherapy cycle and the control cycle is in the first one.
Each subject is required to undergo two cycles of chemotherapy. At the treatment cycle, patients received subcutaneous injection of rhTPO at a dose of 300 U/kg body weight once daily at a platelet count of \< 50×109/L, and rhTPO treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused. At the control cycle, rhTPO therapy is not given.
Each subject is required to be followed up for successive two chemotherapy cycles following inclusion in this study. During the follow-up period, routine blood test is performed once every other day, and platelet transfusion is recorded.
The safety of rhTPO is evaluated by the monitoring of liver and renal functions, blood coagulation, and TPO-neutralizing antibody, and adverse events associated with rhTPO treatment are recorded during the study period.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's enrollment of 58 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:
At the first chemotherapy cycle (treatment cycle), patients receive recombinant human thrombopoietin treatment. At the second chemotherapy cycle (control cycle), recombinant human thrombopoietin therapy is not given.
Drug: recombinant human thrombopoietin
At the first chemotherapy cycle (control cycle), recombinant human thrombopoietin therapy is not given; at the second chemotherapy cycle (treatment cycle), patients receive recombinant human thrombopoietin treatment.
Drug: recombinant human thrombopoietin
Patients received subcutaneous injection of recombinant human thrombopoietin at a dose of 300 U/kg body weight once daily at a platelet count of \< 50×109/L, and recombinant human thrombopoietin treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused.
Also known as: rhTPO
Duration of platelet count of < 20 ´ 109/Lat each cycle of chemotherapy.
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
Time and dose of platelet transfusion at each cycle of chemotherapy
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
The minimum platelet count at each cycle of chemotherapy
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
Duration from the minimum platelet count to ≥ 20´109/L at each cycle of chemotherapy according to CTCAE(v4.0)
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
Number and grade of bleeding Adverse Events at each cycle of chemotherapy
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
Duration of hospital stay (from the first day of chemotherapy to discharge from hospital) at each cycle of chemotherapy
Time frame: From Day1 after chemotherapy up to Day21 after chemotherapy
Plan to share: No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Institute of Hematology & Blood Diseases Hospital, China