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RECRUITING
NCT07446491
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

DRUG

PN20

subcutaneous injection

DRUG

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