Actively Recruiting
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
Led by Chongqing Peg-Bio Biopharm Co., Ltd. · Updated on 2026-03-03
54
Participants Needed
8
Research Sites
55 weeks
Total Duration
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AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Diagnosed with thrombocytopenia related to chronic liver disease with baseline platelet count less than 50 × 10⁹/L and Child-Pugh score A or B
- Scheduled for an elective invasive procedure or minor surgery between 7 and 15 days after enrollment, excluding major surgeries such as laparotomy, thoracotomy, craniotomy, open-heart surgery, or organ resections unless judged similar in risk
- 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 after the study
- Understand study requirements and provide written informed consent
You will not qualify if you...
- Presence of other conditions that may cause thrombocytopenia
- History of thrombotic or significant cardiovascular events
- Uncontrolled bleeding
- Advanced liver cancer
- Severe comorbidities
- Recent major surgery or splenectomy
- Liver transplant
- Recent therapies affecting platelet counts
- Significant laboratory abnormalities
- Recent participation in other clinical trials
- Known hypersensitivity to the study drug
- Active substance abuse
- Any condition the investigator believes compromises safety or study integrity
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Capital Medical University Affiliated Beijing Ditan Hospital
Beijing, Beijing Municipality, China, 100015
Actively Recruiting
2
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400072
Actively Recruiting
3
The Eighth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510405
Actively Recruiting
4
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
5
Zhenjiang Third People's Hospital
Zhenjiang, Jiangsu, China, 212021
Actively Recruiting
6
Jilin University First Hospital
Changchun, Jilin, China, 130033
Actively Recruiting
7
Liaocheng People's Hospital
Chaozhou, Shandong, China, 252000
Actively Recruiting
8
Qingdao Municipal Hospital
Qingdao, Shandong, China, 266001
Actively Recruiting
Research Team
J
Jing Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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