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

NCT07446491 | Recruiting Phase 1

• 1 other identifier: CQPJ-PN20-CLDT-Ib
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Thrombocytopenia Associated With Chronic Liver Disease

Keywords

PN20; Thrombocytopenia; Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• The proportion of responders

  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 Outcomes (4)

• Adverse Events

  From dosing of PN20 (Day 1) to Day 28

• Cmax

  From pre-dose to 8 days after dosing

• AUC

  From pre-dose to 8 days after dosing

• Immunogenicity of PN20

  From pre-dose to 28 days after dosing

Study Arms (2)

PN20 treatment group (1~2 dose goups)

EXPERIMENTAL

A single subcutaneous injection

Drug: PN20

Placebo

PLACEBO COMPARATOR

A single subcutaneous injection

Drug: Placebo

Interventions

PN20 DRUG

subcutaneous injection

PN20 treatment group (1~2 dose goups)

Placebo DRUG

subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing Peg-Bio Biopharm Co., Ltd.: lead

Study Sites (8)

Capital Medical University Affiliated Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

RECRUITING

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400072, China

RECRUITING

The Eighth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510405, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Zhenjiang Third People's Hospital

Zhenjiang, Jiangsu, 212021, China

RECRUITING

Jilin University First Hospital

Changchun, Jilin, 130033, China

RECRUITING

Liaocheng People's Hospital

Chaozhou, Shandong, 252000, China

RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, 266001, China

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Central Study Contacts

Jing Sun

CONTACT

86-13983367811; sunj@pegbiocq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1b: Single group; Phase 2: Parallel.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start: June 6, 2025
• Primary Completion: May 30, 2026
• Study Completion (Estimated): June 28, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CN (8)