drugset / Trial / NCT03673215

The Tolerability,Safety,PK/PD Study of rhTPO in the Patients With Liver Function Impairment

NCT03673215

Phase 0 Unknown 58 enrolled Shenyang Sunshine Pharmaceutical Co., LTD.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics and pharmacodynamics of recombinant human thrombopoietin in the patients with different degree of liver function impairment according Child- Pugh class.

Timeline

Start
2018-06-28
Primary completion
2020-10-08
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject recombinant human thrombopoietin Protein / enzyme biologic 150 iu/kg Subcutaneous
Subject recombinant human thrombopoietin Protein / enzyme biologic 300 iu/kg Subcutaneous
Subject recombinant human thrombopoietin Protein / enzyme biologic 450 iu/kg Subcutaneous

Indications