The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery

August 27, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

The Efficacy and Safety of Herombopag in Treating Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery - A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study

This study includes Part A and Part B. Part A is a dose-finding study for subjects with chronic liver disease-related thrombocytopenia scheduled for elective surgery. Part B is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Herombopag compared to placebo in patients with chronic liver disease-related thrombocytopenia undergoing elective invasive surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital, affiliated with Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males or females aged 18 years or older withc a Child-Pugh score of Class A or Class B;
  2. Platelet count less than 50×10^9/L on baseline;
  3. Elective invasive procedures or surgeries that are planned.

Exclusion Criteria:

  1. Any history of arterial or venous thrombosis, including partial or complete thrombosis;
  2. Evidence of thrombosis (partial or complete) in the main portal vein, portal vein branches, or any part of the splenic mesenteric system at Screening;
  3. Portal vein blood flow velocity rate <10 centimeters/second at Screening;
  4. There are other diseases that may cause thrombocytopenia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group 1
Drug: Herombopag tablets
Herombopag tablets; dose 1 or dose 2, for 5 days
Drug: Herombopag placebo tablets
Herombopag placebo tablets; dose 1 or dose 2, for 5 days
Experimental: Treatment group 2
Drug: Herombopag tablets
Herombopag tablets; dose 1 or dose 2, for 5 days
Drug: Herombopag placebo tablets
Herombopag placebo tablets; dose 1 or dose 2, for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: CL/F
Time Frame: 0 minute to 5 days
0 minute to 5 days
Part A: Vc/F
Time Frame: 0 minute to 5 days
0 minute to 5 days
Part A: ka
Time Frame: 0 minute to 5 days
0 minute to 5 days
Part A: Q/F
Time Frame: 0 minute to 5 days
0 minute to 5 days
Part A: AUC0-tau
Time Frame: 0 minute to 5 days
0 minute to 5 days
Part A: Cmax
Time Frame: 0 minute to 5 days
0 minute to 5 days
Part A: Kin
Time Frame: 0 minute to 35 days
0 minute to 35 days
Part A: Kout
Time Frame: 0 minute to 35 days
0 minute to 35 days
Part A: Kdeg
Time Frame: 0 minute to 35 days
0 minute to 35 days
Part A: Slope
Time Frame: 0 minute to 35 days
0 minute to 35 days
The proportion of subjects whose platelet count is ≥50×10^9/L within 24 hours before surgery and has increased by ≥20×10^9/L from baseline, and who have not received platelet transfusion or other treatments to raise platelet levels before surgery
Time Frame: 0 minute to 11 days
Part B
0 minute to 11 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects with a platelet count of ≥50×10^9/L within 24 hours before surgery
Time Frame: 0 minute to 11 days
0 minute to 11 days
The duration of time during the study when the platelet count remains ≥50×10^9/L
Time Frame: 0 minute to 35 days
0 minute to 35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2024

Primary Completion (Actual)

August 14, 2026

Study Completion (Actual)

August 14, 2026

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR8735-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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