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One-Shot hope: new injection aims to boost platelets before surgery in liver patients

NCT ID NCT07446491

Disease control Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a single injection of PN20, a lab-made protein, to see if it can safely raise platelet counts in adults with chronic liver disease who have low platelets and are scheduled for a minor procedure. About 54 participants will receive either PN20 or a placebo. The main goal is to see if platelet counts stay high enough from one day before to seven days after surgery without needing rescue treatment for bleeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PN20 (a lab-made protein that stimulates platelet production)
What this could lead to
If it works, this could offer a short-term way to safely raise platelet counts before surgery, reducing bleeding risk in liver disease patients.
What could go wrong
This is an early-phase trial with only 54 participants, so results may not apply broadly. The drug may not work as expected or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 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 Criteria: * 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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Conditions

The condition(s) this trial relates to.

acquired thrombocytopenia thrombocytopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thrombocytopenia associated with chronic liver disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Capital Medical University Affiliated Beijing Ditan Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100015, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Jilin University First Hospital

    RECRUITING

    Changchun, Jilin, 130033, China

  • Liaocheng People's Hospital

    RECRUITING

    Chaozhou, Shandong, 252000, China

  • Qingdao Municipal Hospital

    RECRUITING

    Qingdao, Shandong, 266001, China

  • The Eighth Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510405, China

  • The Second Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400072, China

  • Zhenjiang Third People's Hospital

    RECRUITING

    Zhenjiang, Jiangsu, 212021, China