Thrombocytopenia Associated With Chronic Liver DiseasePhase 1/2NCT07446491
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 1/2 study testing PN20 in people with Thrombocytopenia Associated With Chronic Liver Disease, run by Chongqing Peg-Bio Biopharm Co., Ltd. at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia Associated With Chronic Liver Disease
- What is being tested?
- PN20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 8 sitesChina
- Study dates
- 6 Jun 2025to 15 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Capital Medical University Affiliated Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
Jilin University First Hospital
Changchun, Jilin, 130033
Liaocheng People's Hospital
Chaozhou, Shandong, 252000
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400072
The Eighth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510405
Qingdao Municipal Hospital
Qingdao, Shandong, 266001
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Zhenjiang Third People's Hospital
Zhenjiang, Jiangsu, 212021
About this study
Official title: 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.
Read the 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.
- Being tested
- PN20, Placebo
- Keywords
- PN20, Thrombocytopenia, Chronic Liver Disease
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN20Drug
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| PN20 treatment group (1~2 dose goups) | Experimental | A single subcutaneous injection Receives: Drug: PN20 |
| Placebo | Placebo comparator | A single subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 days (from 24 hours pre-surgery through 7 days post-surgery)
Secondary outcomes (4)
Adverse Events
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)
Measured: From dosing of PN20 (Day 1) to Day 28
Cmax
Maximum Plasma Concentration
Measured: From pre-dose to 8 days after dosing
AUC
Area Under the Plasma Concentration-time Curve
Measured: From pre-dose to 8 days after dosing
Immunogenicity of PN20
Using a validated ELISA assay to detect ADAs against the thrombopoietic peptide and polyethylene glycol
Measured: From pre-dose to 28 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start6 Jun 2025
- Primary completion10 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocytopenia Associated With Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1b: Single group; Phase 2: Parallel.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446491
- Sponsor's protocol ID
- CQPJ-PN20-CLDT-Ib
- Status last verified
- Oct 2026
- First submitted
- 26 Feb 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07446491
- Acronym / sponsor ID
- CQPJ-PN20-CLDT-Ib
- Keywords
- PN20, Thrombocytopenia, Chronic Liver Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 10 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase 1b: Single group; Phase 2: Parallel.
| Arm | Type | Receives |
|---|---|---|
| PN20 treatment group (1~2 dose goups) | Experimental | Drug: PN20A single subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboA single subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- The following conditions or medical history:
- Currently using or with a history of the following treatments:
- Significant lab abnormalities;
- Recent participation in other clinical trials;
- Known hypersensitivity to the investigational productstudy drug；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PN20subcutaneous injection | Drug | PN20 treatment group (1~2 dose goups) |
| Placebosubcutaneous injection | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Adverse Events
Time frame: From dosing of PN20 (Day 1) to Day 28
Cmax
Time frame: From pre-dose to 8 days after dosing
AUC
Time frame: From pre-dose to 8 days after dosing
Immunogenicity of PN20
Time frame: From pre-dose to 28 days after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PN20 in people with Thrombocytopenia Associated With Chronic Liver Disease, run by Chongqing Peg-Bio Biopharm Co., Ltd. at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of responders (time frame: 8 days (from 24 hours pre-surgery through 7 days post-surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.