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
Chongqing Peg-Bio Biopharm Co., Ltd.
54 participants
Jun 6, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria15
- 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.
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Interventions
subcutaneous injection
subcutaneous injection
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT07446491