drugset / Trial / NCT03633019

High-dose Use of rhTPO in CIT Patients

NCT03633019

NaSingle-groupOpen-labelTreatment

Summary

The research studies the safety and efficacy of high-dose recombinant human TPO in solid tumor patients with moderate or severe thrombocytopenia induced by chemotherapy. Patients with platelet count lower than 50 x 109/L will be enrolled and treated with high-dose rhTPO (300-600U/kg/day) until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L. During the study, the blood routine test will be regularly performed according to the clinical routine (at least once every two days). Finally, the clinical data will be collected and analyzed to validate the efficacy and safety of high-dose rhTPO therapy.

Timeline

Start
2018-09-28
Primary completion
2019-11-30
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject recombinant human thrombopoietin Protein / enzyme biologic 300 iu/kg Other
Subject recombinant human thrombopoietin Protein / enzyme biologic 600 iu/kg Other

Indications