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

February 26, 2026 updated by: Chongqing Peg-Bio Biopharm Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100015
        • Recruiting
        • Capital Medical University Affiliated Beijing Ditan Hospital
        • Principal Investigator:
          • Yao Xie
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400072
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Principal Investigator:
          • Dazhi Zhang
        • Principal Investigator:
          • Xian Yu
    • Guangdong
      • Guangzhou, Guangdong, China, 510405
        • Recruiting
        • The Eighth Affiliated Hospital of Guangzhou Medical University
        • Principal Investigator:
          • Yujuan Guan
        • Principal Investigator:
          • Kaipeng Huang
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
        • Principal Investigator:
          • Jia Shang
    • Jiangsu
      • Zhenjiang, Jiangsu, China, 212021
        • Recruiting
        • Zhenjiang Third People's Hospital
        • Principal Investigator:
          • Youwen Tan
    • Jilin
      • Changchun, Jilin, China, 130033
        • Recruiting
        • Jilin University First Hospital
        • Principal Investigator:
          • Yanhang Gao
    • Shandong
      • Chaozhou, Shandong, China, 252000
        • Recruiting
        • Liaocheng People's Hospital
        • Principal Investigator:
          • sikui wang
      • Qingdao, Shandong, China, 266001
        • Recruiting
        • Qingdao Municipal Hospital
        • Principal Investigator:
          • Wenwen Jin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years, Male or female
  • Diagnosed with chronic liver disease-related thrombocytopenia (baseline platelet count < 50 × 10⁹/L), Child-Pugh score A or B;
  • Planned elective invasive procedure or minor surgery within Days 7-15 post-enrollment, excluding laparotomy, thoracotomy, craniotomy, open-heart surgery, organ resection, or partial organ resection (for tissue biopsy and other types of tissue resection, enrollment is permitted if the investigator considers the risk of bleeding and invasiveness to be comparable to or lower than that of the procedures listed in the surgical examples list);
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Women of childbearing potential must have a negative pregnancy test
  • Agree to use reliable contraception through 3 months post-study.
  • Participants must understand the study requirements and provide written informed consent.

Exclusion Criteria:

  • The following conditions or medical history:

    • Presence of other conditions that may lead to thrombocytopenia;
    • History of thrombotic or significant cardiovascular events;
    • Uncontrolled bleeding;
    • Advanced liver cancer;
    • Severe comorbidities;

  • Currently using or with a history of the following treatments:

    • Recent major surgery or splenectomy;
    • Liver transplant;
    • Recent therapies affecting platelet counts;
  • Significant lab abnormalities;
  • Recent participation in other clinical trials;
  • Known hypersensitivity to the investigational productstudy drug；
  • Active substance abuse;
  • Any condition deemed by the investigator to compromise safety or study integrity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PN20 treatment group (1~2 dose goups)
A single subcutaneous injection
Drug: PN20
subcutaneous injection
Placebo Comparator: Placebo
A single subcutaneous injection
Drug: Placebo
subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of responders
Time Frame: 8 days (from 24 hours pre-surgery through 7 days post-surgery)
Based on the results of hematology tests, calculate the proportion of participants whose platelet counts remained ≥50×10⁹/L from 24 hours pre-surgery through 7 days post-surgery without requiring rescue treatment for bleeding.
8 days (from 24 hours pre-surgery through 7 days post-surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: From dosing of PN20 (Day 1) to Day 28
Incidence and severity of all adverse events related to PN20 observed through vital signs, physical examinations, 12-lead ECGs, clinical laboratory tests (including hematology, urinalysis, blood chemistry, coagulation function, and pregnancy tests for women of childbearing potential)
From dosing of PN20 (Day 1) to Day 28
Cmax
Time Frame: From pre-dose to 8 days after dosing
Maximum Plasma Concentration
From pre-dose to 8 days after dosing
AUC
Time Frame: From pre-dose to 8 days after dosing
Area Under the Plasma Concentration-time Curve
From pre-dose to 8 days after dosing
Immunogenicity of PN20
Time Frame: From pre-dose to 28 days after dosing
Using a validated ELISA assay to detect ADAs against the thrombopoietic peptide and polyethylene glycol
From pre-dose to 28 days after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Peg-Bio Biopharm Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 28, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQPJ-PN20-CLDT-Ib

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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