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Tests treatment safety and results for Thrombocytopenia Associated With Chronic Liver Disease
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
ClinicalTrials.gov ID: NCT07446491
What this study is testing
What is PN20?
PN20 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for thrombocytopenia associated with chronic liver disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Women of childbearing potential must have a negative pregnancy test
You likely can't join 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;
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Zhenjiang, Jiangsu, China
- Changchun, Jilin, China
- Chaozhou, Shandong, China
- Qingdao, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Zhenjiang, Jiangsu, China; Changchun, Jilin, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.