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The Tolerability，Safety，PK/PD Study of rhTPO in the Patients With Liver Function Impairment | Clinical Trials | Clareo Health

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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

NCT03673215•Shenyang Sunshine Pharmaceutical Co., LTD.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Patients with cirrhosis caused by chronic liver disease who have been diagnosed by biopsy/imaging (Child-Pugh class A, B, and C).
•2\. Life expectancy≥3 months.
•3\. Platelet count≤80×109/ L.
•4\. Fertile female subjects with a negative pregnancy test during the screening period and who agree to take effective contraceptive methods Throughout the study period will be eligible for this study.
•5\. Voluntary written informed consent.

Exclusion Criteria

•1 Subjects allergic to any component of investigational drug.
•2 Subjects with cirrhosis caused by drug-induced liver injury.
•3 Subjects with history of splenectomy or liver transplantation.
•4 Liver cirrhosis with serious complications, including: hepatic encephalopathy, intractable ascites, upper gastrointestinal bleeding, etc.
•5 Subjects with Liver failure.
•6 Tthe presence of portal vein thrombosis or tumor thrombus was indicated by doppler ultrasound or CT or MRI and other imaging examinations within 3 months prior to the beginning of screening.
•7 Subjects with history of arterial or venous thromboembolism, or with thromboembolic disease, or with high risk factors for thrombosis, or with a hereditary tendency to thrombosis, including Antithrombin III deficiency, etc.
•8 Subjects with history of any disease other than chronic liver disease and cirrhosis that may result in decreased platelet count and/or abnormal platelet function, including aplastic anemia, myelodysplastic syndrome (MDS), bone marrow fibrosis, etc.;
•9 Subjects with diseases with higher bleeding risk, such as coagulation factor deficiency or Vascular pseudohemophilia factor deficiency.
•10 Subjects with severe infections that are not effectively controlled.
+11 more criteria

Locations (1)

302 Military Hospital of China

Beijing, Beijing Municipality, China

Key Dates

Start Date

June 28, 2018

Primary Completion Date

October 8, 2020

Completion Date

December 31, 2020

Last Updated

March 23, 2020

Enrollment

ESTIMATED participants

Conditions

Liver Cirrhosis

Interventions

Recombinant human thrombopoietin

DRUG

Recombinant human thrombopoietin

DRUG

Placebo

DRUG

Recombinant human thrombopoietin

DRUG

Placebo

DRUG

recombinant human thrombopoietin

DRUG

placebo

DRUG

Recombinant human thrombopoietin

DRUG

placebo

DRUG

Contacts

Quanrui WU, Master

CONTACT

86 10 84892211 wuquanrui@3sbio.com

Sunqiong Cao, MD

CONTACT

86 10 84892211 caosunqiong@3sbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

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Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial

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