drugset / Trial / NCT02267993

Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia After Chemotherapy in AML Patients

NCT02267993

RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2014-10
Primary completion
2018-08-01
Completion
2018-08-31

Drugs

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

Indications