NCT03673215

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

A Phase Ia Dose-escalation Study to Access the Tolerability，Safety，Pharmacokinetics and Pharmacodynamics of Recombinant Human Thrombopoietin in the Patients With Different Degree of Liver Function Impairment

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, placebo controlled, dose-escalation phase Ia study to evaluate the tolerability, safety, pharmacokinetics and pharmacodynamics of recombinant human thrombopoietin. According Child- Pugh class of liver function impairment and different dose of recombinant human thrombopoietin, nine arms be designed in this study. Each subject in Arm A will be only administered recombinant human thrombopoietin. Each subject in Arm B and C will be randomly assigned to accept either recombinant human thrombopoietin or placebo in 5:1 ratio.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	Recombinant human thrombopoietin	Recombinant human thrombopoietin will be administered single dose 300 U/Kg subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class A
DRUG	Recombinant human thrombopoietin	Recombinant human thrombopoietin will be administered single dose 300 U/Kg subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class B.
DRUG	Placebo	Placebo will be administered single dose subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class B.
DRUG	Recombinant human thrombopoietin	Recombinant human thrombopoietin will be administered single dose 150 U/Kg subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C.
DRUG	Placebo	Placebo will be administered single dose subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C
DRUG	recombinant human thrombopoietin	Recombinant human thrombopoietin will be administered single dose 300 U/Kg subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C.
DRUG	placebo	Placebo will be administered single dose subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C
DRUG	Recombinant human thrombopoietin	Recombinant human thrombopoietin will be administered single dose 450 U/Kg subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C.
DRUG	placebo	Placebo will be administered single dose subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C

Timeline

• Start date: 2018-06-28
• Primary completion: 2020-10-08
• Completion: 2020-12-31
• First posted: 2018-09-17
• Last updated: 2020-03-23

Locations

1 site across 1 country: China