NCT07446491

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is aan open-label, single-dose, dose-escalation phase Ib/II study conducted in two stages, Phase Ib and Phase II, designed to evaluate the safety, tolerability, efficacy, PK, PD, and immunogenicity of PN20 in patients with CLDT in patients with CLDT. Phase Ib stage is an open-label, single-dose, dose-escalation study. Three dose levels (8 participants per group) will be administered sequentially from low to high. Phase 2 stage is a randomized, double-blind, single-dose, placebo-controlled study. Eligible patients are randomized in a 1:1 ratio to the treatment or placebo group following informed consent. The dosing regimen in the treatment group is selected based on the Phase Ib results, with one or two dose levels selected. If two PN20 dose levels are selected, randomization follows a 1:1:1 ratio to one of the two treatment groups or to the placebo group.

Conditions

• Thrombocytopenia Associated With Chronic Liver Disease

Interventions

Type	Name	Description
DRUG	PN20	subcutaneous injection
DRUG	Placebo	subcutaneous injection

Timeline

• Start date: 2025-06-06
• Primary completion: 2026-05-30
• Completion: 2026-06-28
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

8 sites across 1 country: China