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A Study to Evaluate the Safety and Efficacy of PN20 in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure
Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd.
Summary
The main aim of this clinical trial is to assess the safety and efficacy of a single dose of PN20 in treatment of thrombocytopenia in adult patients with chronic liver disease undergoing an elective procedure. The main questions it aims to answer are: * How effective is PN20 in treating thrombocytopenia in patients with chronic liver disease? * Is PN20 safe in these patients? Participants will * Receive a single subcutaneous injections of PN20 or placebo according to weight before an elective procedure, * Visit the clinic for assessment.
Official title: A Phase Ib/II Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Characteristics of a Single Subcutaneous Injection of Polyethylene Glycolated Thrombopoietin Peptide (PN20) in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2025-06-06
Completion Date
2026-06-28
Last Updated
2026-03-03
Healthy Volunteers
No
Interventions
PN20
subcutaneous injection
Placebo
subcutaneous injection
Locations (8)
Capital Medical University Affiliated Beijing Ditan Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Eighth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Zhenjiang Third People's Hospital
Zhenjiang, Jiangsu, China
Jilin University First Hospital
Changchun, Jilin, China
Liaocheng People's Hospital
Chaozhou, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China