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

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.

Conditions

• Liver Cirrhosis

Interventions

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

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-28

Primary Completion

2020-10-08

Completion

2020-12-31

Countries

• China

Study Locations